Global & Disaster Medicine

Archive for the ‘Neglected Tropical Diseases’ Category

Madariaga virus in Haitian children

PLOS

Lednicky JA, White SK, Mavian CN, El Badry MA, Telisma T, Salemi M, et al. (2019) Emergence of Madariaga virus as a cause of acute febrile illness in children, Haiti, 2015-2016. PLoS Negl Trop Dis 13(1): e0006972. https://doi.org/10.1371/journal.pntd.0006972 

“……While most MADV case reports have involved patients with encephalitis, it is likely that the majority of infections occur in persons who are asymptomatic or who have only relatively mild disease …..In Haiti, no prior data are available on MADV in vectors, animal reservoirs, or humans. While we cannot exclude the possibility that MADV was present in Haiti before the current case cluster, our phylogenetic studies are strongly suggestive of recent introduction of the virus into Haiti from Panama. ….”

The hump-nosed pit viper (Hypnale hypnale)

Kumar KS, Narayanan S, Udayabhaskaran V, Thulaseedharan NK.

Clinical and epidemiologic profile and predictors of outcome of poisonous snake bites – an analysis of 1,500 cases from a tertiary care center in Malabar, North Kerala, India. Int J Gen Med. 2018;11:209-216. Published 2018 Jun 5. doi:10.2147/IJGM.S136153

  • No antidote available for its deadly venom.
  • Also called the hump-nosed moccasin for its pointed and upturned snout
  • A major killer endemic to the Western Ghats, a mountain range of South India, and Sri Lanka.
  • The standard polyvalent antivenom used for the four most poisonous snakes of the region — the Indian cobra (Naja naja), Indian krait (Bangarus caeruleus), Russell’s viper (Daboia russelii) and saw-scaled viper (Echis carinatus) — does not work on hump-nosed pit viper venom.
  • Hump-nosed pit viper envenomation typically brings on acute kidney injury leading to corticoid necrosis and death

Black mamba: One of the most feared snake species of the African savanna.

Nature

In vivo neutralization of dendrotoxin-mediated neurotoxicity of black mamba venom by oligoclonal human IgG antibodies

Nature Communications volume 9, Article number: 3928 (2018)

“…..The black mamba (Dendroaspis polylepis) is one of the most feared snake species of the African savanna. It has a potent, fast-acting neurotoxic venom comprised of dendrotoxins and α-neurotoxins associated with high fatality in untreated victims. Current antivenoms are both scarce on the African continent and present a number of drawbacks as they are derived from the plasma of hyper-immunized large mammals…..”

  • “…Snakebite envenoming exacts a death toll of 80–150,000 victims each year, leaves approximately four times as many maimed for life1, and has recently been recognized as a Neglected Tropical Disease by the World Health Organization (WHO)….”
  • “:…..The notorious black mamba (Dendroaspis polylepis) from sub-Saharan Africa is a particularly dangerous species due to its size, defensive nature, and fast-acting neurotoxic venom. Life threatening clinical manifestations of D. polylepis envenoming include flaccid paralysis due to blockade of neuromuscular transmission resulting from inhibition of nicotinic acetylcholine receptors in the peripheral nervous system caused by α-neurotoxins (both short-chain and long-chain types) of the three-finger toxin superfamily….”

Image result for Black Mamba

The Black Mamba


Small molecule therapeutics (SMTs) polymer nanoparticles (NP) and have been proposed as potential prereferral treatments for snakebite

Bulfone TC, Samuel SP, Bickler PE, Lewin MR.

Developing Small Molecule Therapeutics for the Initial and Adjunctive Treatment of Snakebite.

J Trop Med. 2018;2018:4320175. Published 2018 Jul 30. doi:10.1155/2018/4320175

  • Snakebite envenomation is a neglected tropical disease that causes more than 100,000 deaths every year
  • SMTs represent a potentially useful adjunctive therapy to antivenoms, the current mainstay of care for symptomatic snakebite.

Engineered nanoparticles bind elapid snake venom toxins and inhibit venom-induced dermonecrosis

  • Jeffrey O’Brien,
  • Shih-Hui Lee,
  • José María Gutiérrez,
  • Kenneth J. Shea
PLOS

“…..The work describes hope for treatment of snakebite, a broad-spectrum antivenom comprised polymer nanoparticles (NPs) engineered to sequester the major protein toxins in elapid snakes. The stable, low-cost NPs can be administered subcutaneously immediately after the bite at the site of envenoming to halt or reduce the extent of local tissue damage and mitigate the systemic distribution of toxins post-envenoming…..”

 

 


India experiences the world’s largest absolute burden of at least 11 major NTDs.

PLOS

Hotez PJ, Damania A (2018) India’s neglected tropical diseases. PLoS Negl Trop Dis 12(3): e0006038. https://doi.org/10.1371/journal.pntd.0006038


The U.S. FDA today granted accelerated approval to benznidazole for use in children ages 2 to 12 years old with Chagas disease — the first treatment approved in the United States for the treatment of Chagas disease.

FDA

WHO

The U.S. Food and Drug Administration today granted accelerated approval to benznidazole for use in children ages 2 to 12 years old with Chagas disease. It is the first treatment approved in the United States for the treatment of Chagas disease.

Chagas disease, or American trypanosomiasis, is a parasitic infection caused by Trypanosoma cruzi and can be transmitted through different routes, including contact with the feces of a certain insect, blood transfusions, or from a mother to her child during pregnancy. After years of infection, the disease can cause serious heart illness, and it also can affect swallowing and digestion. While Chagas disease primarily affects people living in rural parts of Latin America, recent estimates are that there may be approximately 300,000 persons in the United States with Chagas disease.

Adult Rhodnius prolixus taking a blood meal through human skin

“The FDA is committed to making available safe and effective therapeutic options to treat tropical diseases,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

The safety and efficacy of benznidazole were established in two placebo-controlled clinical trials in pediatric patients 6 to 12 years old. In the first trial, approximately 60 percent of children treated with benznidazole had an antibody test change from positive to negative compared with approximately 14 percent of children who received a placebo. Results in the second trial were similar: Approximately 55 percent of children treated with benznidazole had an antibody test change from positive to negative compared with 5 percent who received a placebo. An additional study of the safety and pharmacokinetics (how the body absorbs, distributes and clears the drug) of benznidazole in pediatric patients 2 to 12 years of age provided information for dosing recommendations down to 2 years of age.

 

The most common adverse reactions in patients taking benznidazole were stomach pain, rash, decreased weight, headache, nausea, vomiting, abnormal white blood cell count, urticaria (hives), pruritus (itching) and decreased appetite. Benznidazole is associated with serious risks including serious skin reactions, nervous system effects and bone marrow depression. Based on findings from animal studies, benznidazole could cause fetal harm when administered to a pregnant woman.

Benznidazole was approved using the Accelerated Approval pathway. The Accelerated Approval pathway allows the FDA to approve drugs for serious conditions where there is unmet medical need and adequate and well-controlled trials establish that the drug has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients. Further study is required to verify and describe the anticipated clinical benefit of benznidazole.

The FDA granted benznidazole priority review and orphan product designation. These designations were granted because Chagas disease is a rare disease, and until now, there were no approved drugs for Chagas disease in the United States.

With this approval, benznidazole’s manufacturer, Chemo Research, S. L., is awarded a Tropical Disease Priority Review Voucher in accordance with a provision included in the Food and Drug Administration Amendments Act of 2007 that aims to encourage development of new drugs and biological products for the prevention and treatment of certain tropical diseases.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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WHO reinstates snake-bite envenoming to its list of category A neglected tropical diseases

Lancet

Every year, more than 95 000 people die from snake bite, and a further 300 000 survive but with permanent disability or disfigurement.

An estimated 1·8–2·7 million people a year develop serious clinical illness (envenoming) after snake bite.

Most victims of snake bite live in the world’s poorest communities, with agricultural workers, children, and rural dwellers most at risk. About half of documented deaths from snake bite are in India but data from sub-Saharan Africa are fragmentary, and the burden of disease and the poverty it causes is likely to be underestimated. In Africa, a young farmer bitten by a puff adder might suffer terrible disfigurement rendering him fit only to beg, or the stigmatisation of scars from a spitting cobra bite might lead to a girl being unmarriageable.

WHO added snake bite to the list of NTDs in 2009, but it was later removed without explanation. …..”


WHO’s new list of neglected tropical diseases

 

WHO

Neglected tropical diseases (NTDs)– a diverse group of communicable diseases that prevail in tropical and subtropical conditions in 149 countries – affect more than one billion people and cost developing economies billions of dollars every year. Populations living in poverty, without adequate sanitation and in close contact with infectious vectors and domestic animals and livestock are those worst affected.

Effective control can be achieved when selected public health approaches are combined and delivered locally. Interventions are guided by the local epidemiology and the availability of appropriate measures to detect, prevent and control diseases. Implementation of appropriate measures with high coverage will contribute to achieving the targets of the WHO NTD Roadmap on neglected tropical diseases, resulting in the elimination of many and the eradication of at least two by 2020.

In May 2013, the 66th World Health Assembly resolved to intensify and integrate measures against neglected tropical diseases and to plan investments to improve the health and social well-being of affected populations. WHO is working with Member States to ensure the implementation of resolution WHA66.12.

In 2016, the 69th Assembly adopted resolution WHA69.21 on addressing the burden of mycetoma and requested WHO, through the Strategic and Technical Advisory for Neglected Tropical Diseases, “to define a systematic, technically-driven process for evaluation and potential inclusion of additional diseases among the ‘neglected tropical diseases’”.

Accordingly, in 2017 the 10th meeting of the Strategic and Technical Advisory Group for Neglected Tropical Diseases received proposals for the addition of diseases and, pursuant to the required procedures, chromoblastomycosis and other deep mycosesscabies and other ectoparasites and snakebite envenoming have been added to the NTD portfolio:


CDC’s Emergency Drugs for US Clinicians and Hospitals

CDC

Our Formulary

The following information is provided as an informational resource for guidance only. It is not intended as a substitute for professional judgment. These highlights and any hyperlinks may not include all the information needed to use each respective drug or biologic safely and effectively. See full prescribing information (package insert) or IND protocol for each respective drug or biologic, which accompany the product when it is delivered to the treating physician and/or pharmacist.

The Drug Service formulary is subject to change based on current public health needs, updates to treatment guidelines, and/or drug availability. For historical reference, we have included products no longer supplied by the Drug Service.

Product & Supplier Indication & Eligibility How Supplied
Anthrax Vaccine Absorbed

(Also known as “AVA”; BioThrax®, Emergent BioSolutions)

For the active immunization for the prevention of disease caused by Bacillus anthracis, in persons 18 through 65 years of age at high risk for exposure

Because the risk for anthrax infection in the general population is low, routine immunization is not recommended

The safety and efficacy of BioThrax® in a post-exposure setting have not been established.

Suspension for injection in 5 mL multidose vials, each containing 10 doses
Artesunate, intravenous

(Supplied to CDC by the Walter Reed Army Institute of Research)

For the treatment of severe malaria in patients who require parenteral (IV) therapy

Patient must meet the eligibility criteria in the IND protocol

110 mg; sterile dry-filled powder with phosphate buffer diluent for reconstitution
Benznidazole

(Benznidazol, Manufactured by LAFEPE)

For the treatment of American trypanosomiasis (Chagas disease)

Patient must meet the eligibility criteria in the IND protocol

100 mg double-scored tablet

12.5 mg dispersible tablet for pediatric use

Botulism Antitoxin Heptavalent (Equine), Types A-G

(Also known as “HBAT”; Manufactured by Cangene Corp. – BAT™)

For the treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin 20 mL or 50 mL single-use glass vial

May be received frozen or thawed

Diethylcarbamazine

(Also known as “DEC”; Supplied to CDC by the World Health Organization; Manufactured by E.I.P.I.C.O.)

For the treatment of certain filarial diseases, including lymphatic filariasis caused by infection with Wuchereria bancrofti, Brugia malayi, or Brugia timori; tropical pulmonary eosinophilia; and loiasis

For prophylactic use in persons determined to be at increased risk for Loa loa infection

Patient must meet the eligibility criteria in the IND protocol

100 mg tablet
Diphtheria Antitoxin (Equine)

(Also known as “DAT”; Manufactured by Instituto Butantan)

For prevention or treatment of actual or suspected cases of diphtheria

Patient must meet the eligibility criteria in the IND protocol

1 mL single-use ampule containing 10,000 units
Eflornithine

(Also known as “DFMO”; Supplied to CDC by the World Health Organization; Manufactured by Sanofi Aventis – Ornidyl®)

For the treatment of second-stage African trypanosomiasis (sleeping sickness) caused by Trypanosoma brucei gambiense, with involvement of the central nervous system 20 g/100 mL hypertonic solution for IV infusion

Must be diluted with Sterile Water for Injection before use

Melarsoprol

(Supplied to CDC by the World Health Organization; Manufactured by Sanofi Aventis – Arsobal®)

For the treatment of second-stage African trypanosomiasis (sleeping sickness), with involvement of the central nervous system

Patient must meet the eligibility criteria in the IND protocol

5 mL glass ampule containing 180 mg/5 mL (36 mg/mL)
Nifurtimox

(Supplied to CDC by the World Health Organization; Manufactured by Bayer – Lampit®)

For the treatment of American trypanosomiasis (Chagas disease)

Patient must meet the eligibility criteria in the IND protocol

120 mg double-scored tablet
Sodium Stibogluconate

(Manufactured by GlaxoSmithKline, UK – Pentostam®)

For the treatment of leishmaniasis

Patient must meet the eligibility criteria in the IND protocol

Solution for injection in 100 mL multidose bottle

100 mg pentavalent antimony (Sb) per mL

Suramin

(Supplied to CDC by the World Health Organization; Manufactured by Bayer – Germanin)

For the treatment of first-stage African trypanosomiasis (sleeping sickness) caused by Trypanosoma brucei rhodesiense, without involvement of the central nervous system

Patient must meet the eligibility criteria in the IND protocol

1 gram of suramin for injection in a 10 mL vial (100 mg/mL solution of suramin sodium)

Must be reconstituted with 10 mL Sterile Water for Injection before use

Vaccinia Vaccine

(Also known as the “Smallpox Vaccine”; Manufactured by Sanofi Aventis – ACAM2000®)

For active immunization against smallpox disease for persons determined to be at high risk for smallpox infection Lyophilized powder reconstituted with diluent (provided)

Contains 100 doses per vial

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Anthrax Vaccine Adsorbed

Anthrax Vaccine Adsorbed (AVA) is indicated for the active immunization for the prevention of disease caused by Bacillus anthracis, in persons 18 through 65 years of age at high risk for exposure. The safety and efficacy of AVA in a post-exposure setting have not been established.

CDC provides anthrax vaccine for laboratory workers conducting research under federally funded projects who require preexposure vaccination based on their occupational risk.

Preexposure vaccination is recommended for laboratorians at risk for repeated exposure to fully virulent B. anthracis spores, such as those who 1) work with high concentrations of spores with potential for aerosol production; 2) handle environmental samples that might contain powders and are associated with anthrax investigations; 3) routinely work with pure cultures of B. anthracis; 4) frequently work in spore-contaminated areas after a bioterrorism attack; or 5) work in other settings where repeated exposures to B. anthracis aerosols may occur. Read more[PDF – 36 pages](https://www.cdc.gov/mmwr/pdf/rr/rr5906.pdf).

More Information for Clinicians

CDC’s Anthrax Vaccination Website

Educational Toolkit for Clinicians (from Department of Defense Anthrax Immunization Program)

Vaccine Information Statement (VIS) for Anthrax Vaccine[PDF – 2 pages](https://www.cdc.gov/vaccines/hcp/vis/vis-statements/anthrax.pdf)

Full Prescribing Information for BioThrax®

How to Request

Anthrax vaccine must be administered by or under the supervision of the physician who registers with CDC.

Contact the CDC Drug Service for more information.

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Artesunate, Intravenous

Artesunate is in the class of medications known as artemesinins, which are derivatives from the “qinghaosu” or sweet wormwood plant (Artemisia annua). Artesunate is not currently licensed by FDA but is made available in the United States under a CDC-sponsored IND protocol for treatment of documented cases of severe malaria(https://www.cdc.gov/malaria/about/index.html) that require parenteral therapy. Read more(https://www.cdc.gov/malaria/diagnosis_treatment/artesunate.html).

More Information for Clinicians

Diagnostic assistance for malaria is available through DPDx.

How to Request

Clinicians who wish to obtain artesunate for severe malaria should contact the CDC Malaria Hotline at 770-488-7788 (M-F, 8am-4:30pm, Eastern time) or, after hours, the CDC Emergency Operations Center (EOC) at 770-488-7100, and request to speak with a CDC Malaria Branch clinician. A Malaria Branch clinician will provide clinical consultation by telephone and, if indicated, authorize the emergency release of artesunate from one of the CDC Quarantine Stations located in major airports around the nation, ensuring delivery to any location in the United States within hours.

Requests for unapproved uses cannot be granted.

For non-emergency questions related to artesunate IV, contact the CDC Drug Service.

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Benznidazole

Benznidazole is a 2-nitroimidazole trypanocidal agent that was introduced in 1971 for the treatment of Trypanosoma cruzi infection—i.e., Chagas disease, also known as American trypanosomiasis(https://www.cdc.gov/parasites/chagas/). Benznidazole is one of two drugs available from CDC for the treatment of Chagas disease (the other is nifurtimox). In the United States, the need to have drugs available for treating Chagas disease has been increasing, largely because of implementation of T. cruzi blood-donor screening in 2007, which has identified chronically infected persons (mainly Latin American immigrants) who might benefit from treatment and has heightened awareness of Chagas disease.

More Information for Clinicians

Evaluation and Treatment of Chagas Disease in the United States: A Systematic Review (JAMA 2007: 298:2171-81)

Screening and Treatment of Chagas Disease in Organ Transplant Recipients in the United States: Recommendations from the Chagas in Transplant Working Group (American Journal of Transplantation, 2011: 672–680)

Diagnostic assistance for American trypanosomiasis is available through DPDx.

How to Request

Contact the CDC Drug Service for more information.

Questions regarding treatment of Chagas disease should be directed to CDC Parasitic Diseases Inquiries (404-718-4745; email chagas@cdc.gov) M-F 7:30am-4pm EST.

For emergencies (for example, acute Chagas disease with severe manifestations, Chagas disease in a newborn, or Chagas disease in an immunocompromised person) outside of regular business hours, call the CDC Emergency Operations Center (770-488-7100) and ask for the person on call for Parasitic Diseases.

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Botulism Antitoxin Heptavalent (Equine), Types A-G

Botulism Antitoxin Heptavalent (HBAT) contains equine-derived antibody to the seven known botulinum toxin types (A-G). HBAT is composed of <2% intact immunoglobulin G (IgG) and ≥90% Fab and F(ab’)2 immunoglobulin fragments. These fragments are created by the enzymatic cleavage and removal of Fc immunoglobulin components in a process sometimes referred to as despeciation. HBAT is supplied on an emergency basis for the treatment of persons thought to be suffering from botulism and works by neutralizing unbound toxin molecules. In 2010, HBAT became the only botulism antitoxin available in the United States for naturally occurring non-infant botulism.

It is available only from CDC because of its limited use and its relatively short expiration date. The antitoxin is stored at CDC Quarantine Stations located in major airports around the nation, ensuring delivery to any location in the United States within hours.

BabyBIG® (botulism immune globulin) remains available for infant botulism through the California Infant Botulism Treatment and Prevention Program.

More Information for Clinicians

Clinical Guidance

How to Request

Clinicians who suspect a diagnosis of botulism in a patient should immediately call their state health department’s 24-hour telephone number(https://www.cdc.gov/mmwr/international/relres.html) to maintain effective botulism surveillance and to facilitate rapid detection of outbreaks. The state health department will contact CDC to arrange for a clinical consultation by telephone and, if indicated, release of botulism antitoxin. State health departments requesting botulism antitoxin should contact the CDC Emergency Operations Center (EOC) at 770-488-7100. Read more(https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5232a8.htm).

For non-emergency questions concerning botulism antitoxin, contact the CDC Drug Service.

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Diethylcarbamazine (DEC)

DEC is an antihelminthic agent used for treatment of lymphatic filariasis (caused by infection with Wuchereria bancrofti, Brugia malayi, or Brugia timori), tropical pulmonary eosinophilia, and loiasis(https://www.cdc.gov/parasites/loiasis/); DEC also has prophylactic benefit for Loa loa infection. DEC has been used worldwide for more than 50 years. In the past, Wyeth-Ayerst Laboratories made DEC available as a licensed drug; in the late 1990s, because of unavailability of a bulk chemical supplier, Wyeth-Ayerst discontinued distribution of DEC in the United States.

More Information for Clinicians

Diagnostic assistance for filarial diseases is available through DPDx.

How to Request

Contact the CDC Drug Service for more information.

Questions regarding treatment of filarial diseases should be directed to CDC Parasitic Diseases Inquiries (404-718-4745; email parasites@cdc.gov) M-F 7:30am-4pm EST.

After-hours emergencies: 1-770-488-7100

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Diphtheria Antitoxin (Equine)

Diphtheria antitoxin (DAT) is used to prevent or treat diphtheria by neutralizing the toxins produced by Corynebacterium diphtheriae. DAT is a sterile, aqueous solution of the refined and concentrated proteins, chiefly globulins, containing antibodies obtained from the serum of horses that have been immunized against diphtheria toxin. DAT is available under an IND protocol sponsored by CDC and is released only for actual or suspected cases of diphtheria(https://www.cdc.gov/diphtheria/about/index.html). The antitoxin is stored at CDC Quarantine Stations located in major airports around the nation, ensuring delivery to any location in the United States within hours.

More Information for Clinicians

CDC’s Vaccine-Related Topics: Diphtheria Antitoxin(https://www.cdc.gov/diphtheria/dat.html)

How to Request

Clinicians who suspect a diagnosis of respiratory diphtheria can obtain DAT by contacting the Emergency Operations Center at 770-488-7100. They will be connected with the diphtheria duty officer, who will provide clinical consultation and, if indicated, initiate the release of diphtheria antitoxin.

For non-emergency questions concerning diphtheria antitoxin, contact the CDC Drug Service.

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Eflornithine

Eflornithine is an antitrypanosomal agent that inhibits the enzyme ornithine decarboxylase. Antitrypanosomal treatment is indicated for all persons diagnosed with African trypanosomiasis (sleeping sickness)(https://www.cdc.gov/parasites/sleepingsickness/); the choice of therapy depends on the infecting subspecies of the parasite and on the stage of the infection. Eflornithine is considered the drug of choice for the treatment of second-stage Trypanosoma brucei gambiense (West African) infection, with involvement of the central nervous system. It is not effective against T. b. rhodesiense (East African) infection (see melarsoprol). Although the manufacturer, Aventis, maintains its US licensure, eflornithine is not commercially available in the United States.

More Information for Clinicians

Human African trypanosomiasis, WHO

Diagnostic assistance for African trypanosomiasis is available through DPDx.

How to Request

Contact the CDC Drug Service for more information.

Questions regarding treatment of African trypanosomiasis should be directed to CDC Parasitic Diseases Inquiries (404-718-4745; email parasites@cdc.gov) M-F 7:30am-4pm EST.

For emergencies outside of regular business hours, call the CDC Emergency Operations Center (770-488-7100) and ask for the person on call for Parasitic Diseases.

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Melarsoprol

Melarsoprol is an organoarsenic compound with trypanocidal effects that has been used outside the United States since 1949. Antitrypanosomal treatment is indicated for all persons diagnosed with African trypanosomiasis (sleeping sickness)(https://www.cdc.gov/parasites/sleepingsickness/); the choice of therapy depends on the infecting subspecies of the parasite and on the stage of the infection. Melarsoprol is used for the treatment of second-stage infection (involving the central nervous system). It is the only available therapy for second-stage Trypanosoma brucei rhodesiense (East African) infection, whereas eflornithine typically is used for second-stage T. b. gambiense (West African) infection.

More Information for Clinicians

Human African trypanosomiasis, WHO

Diagnostic assistance for African trypanosomiasis is available through DPDx.

How to Request

Contact the CDC Drug Service for more information.

Questions regarding treatment of African trypanosomiasis should be directed to CDC Parasitic Diseases Inquiries (404-718-4745; email parasites@cdc.gov) M-F 7:30am-4pm EST.

For emergencies outside of regular business hours, call the CDC Emergency Operations Center (770-488-7100) and ask for the person on call for Parasitic Diseases.

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Nifurtimox

Nifurtimox is a nitrofuran analog that was introduced in 1965 for the treatment of Trypanosoma cruzi infection—i.e., Chagas disease, also known as American trypanosomiasis(https://www.cdc.gov/parasites/chagas/). Nifurtimox is one of two drugs available from CDC for the treatment of Chagas disease (the other is benznidazole). In the United States, the need to have drugs available for treating Chagas disease has been increasing, largely because of implementation of T. cruzi blood-donor screening in 2007, which has identified chronically infected persons (mainly Latin American immigrants) who might benefit from treatment and has heightened awareness of Chagas disease.

More Information for Clinicians

Evaluation and Treatment of Chagas Disease in the United States: A Systematic Review (JAMA 2007: 298:2171-81)

Screening and Treatment of Chagas Disease in Organ Transplant Recipients in the United States: Recommendations from the Chagas in Transplant Working Group (American Journal of Transplantation, 2011: 672–680)

Diagnostic assistance for American trypanosomiasis is available through DPDx.

How to Request

Contact the CDC Drug Service for more information.

Questions regarding treatment of Chagas disease should be directed to CDC Parasitic Diseases Inquiries (404-718-4745; email chagas@cdc.gov) M-F 7:30am-4pm EST.

For emergencies (for example, acute Chagas disease with severe manifestations, Chagas disease in a newborn, or Chagas disease in an immunocompromised person) outside of regular business hours, call the CDC Emergency Operations Center (770-488-7100) and ask for the person on call for Parasitic Diseases.

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Sodium Stibogluconate

Sodium stibogluconate (Pentostam®) is a pentavalent antimony compound used for treatment of leishmaniasis(https://www.cdc.gov/parasites/leishmaniasis). The three main clinical syndromes in humans are visceral, cutaneous, and mucosal leishmaniasis. Pentostam is a well-established antileishmanial agent that has been used in many countries of the world for more than half a century.

More Information for Clinicians

Recommendations for Treating Leishmaniasis with Sodium Stibogluconate (Pentostam) and Review of Pertinent Clinical Studies (Am J Trop Med 1992:46(3):296-306)[PDF, 11 pages]

Diagnostic assistance for leishmaniasis is available through DPDx.

Practical Guide for Laboratory Diagnosis of Leishmaniasis[PDF, 4 pages](https://www.cdc.gov/parasites/leishmaniasis/resources/pdf/cdc_diagnosis_guide_leishmaniasis.pdf)

How to Request

Contact the CDC Drug Service for more information.

Questions regarding treatment of leishmaniasis should be directed to CDC Parasitic Diseases Inquiries (404-718-4745; email parasites@cdc.gov) M-F 7:30am-4pm EST.

After-hours emergencies: 1-770-488-7100

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Suramin

Suramin is a negatively charged, high-molecular-weight sulfated naphthylamine. It was introduced in the 1920s for the treatment of African trypanosomiasis (sleeping sickness)(https://www.cdc.gov/parasites/sleepingsickness/). Suramin generally is considered the drug of choice for first-stage Trypanosoma brucei rhodesiense (East African) infection, without involvement of the central nervous system. Pentamidine typically is used for first-stage T. b. gambiense (West African) infection.

More Information for Clinicians

Human African trypanosomiasis, WHO

Diagnostic assistance for African trypanosomiasis is available through DPDx.

How to Request

Contact the CDC Drug Service for more information.

Questions regarding treatment of African trypanosomiasis should be directed to CDC Parasitic Diseases Inquiries (404-718-4745; email parasites@cdc.gov) M-F 7:30am-4pm EST.

For emergencies outside of regular business hours, call the CDC Emergency Operations Center (770-488-7100) and ask for the person on call for Parasitic Diseases.

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Vaccinia Vaccine, “Smallpox Vaccine”

Smallpox vaccine is made of live vaccinia virus derived from plaque purification cloning of Dryvax® (calf lymph vaccine, New York City Board of Health Strain) and grown in African Green Monkey kidney (Vero) cells and tested to be free of adventitious agents. It contains approximately 2.5 – 12.5 x 105 plaque-forming units per dose.

Smallpox was declared globally eradicated in 1980. In 1982, Wyeth Laboratories, the only active manufacturer of licensed vaccinia vaccine in the United States, discontinued production; and, in 1983, distribution to the civilian population was discontinued. Since January 1982, smallpox vaccination has not been required for international travelers, and International Certificates of Vaccination no longer include smallpox vaccination. ACAM2000® is a new-generation smallpox vaccine that was licensed in 2010 for use as a medical countermeasure held by the Strategic National Stockpile.

CDC recommends vaccinia vaccine for laboratory workers who directly handle a) cultures or b) animals contaminated or infected with nonhighly attenuated vaccinia virus, recombinant vaccinia viruses derived from nonhighly attenuated vaccinia strains, or other orthopoxviruses that infect humans (e.g., monkeypox, cowpox, vaccinia, and variola). Other health-care workers (e.g., physicians and nurses) whose contact with nonhighly attenuated vaccinia viruses is limited to contaminated materials (e.g., dressings) and who adhere to appropriate infection control measures are at lower risk for inadvertent infection than laboratory workers. However, because a theoretical risk for infection exists, vaccination can be offered to this group. Read more[PDF – 930KB](https://www.cdc.gov/mmwr/pdf/rr/rr5010.pdf).

More Information for Clinicians

Full Prescribing Information for ACAM2000®[PDF – 11 pages]

ACAM2000® Medication Guide[PDF – 6 pages]

MMWR Notice to Readers: Newly Licensed Smallpox Vaccine to Replace Old Smallpox Vaccine(https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5708a6.htm)

CDC’s Vaccine-Related Topics: Smallpox Vaccine

How to Request

Smallpox vaccine must be administered by or under the supervision of the physician who registers with CDC.

Ancillary supplies, such as bifurcated needles (for administration) and 1 mL tuberculin syringes with 25 gauge x 5/8″ needles (for reconstitution), are supplied with the vaccine.

Contact the CDC Drug Service for more information.

Requests for unapproved uses cannot be granted.

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Products No Longer Supplied by Drug Service*

Botulinum Toxoid

Pentavalent (ABCDE) botulinum toxoid is a combination of aluminum phosphate-adsorbed toxoid derived from formalin-inactivated types A, B, C, D, and E botulinum toxins, with formaldehyde and thimerosal used as preservatives. Botulinum toxoid was distributed by CDC under an IND protocol for at-risk persons who were actively working or expected to be working with cultures of Clostridium botulinum or the toxins; in 2011, CDC discontinued its program to supply this vaccine. Read more(https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6042a3.htm).

Botulinum Antitoxin Types AB & E

In March 2010, CDC announced the availability of a new heptavalent botulinum antitoxin (HBAT, Cangene Corporation). HBAT replaced the licensed bivalent botulinum antitoxin AB and an investigational monovalent botulinum antitoxin E (BAT-AB and BAT-E, Sanofi Pasteur), becoming the only botulinum antitoxin available in the United States for naturally occurring non-infant botulism. Read more(https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5910a4.htm).

Vaccinia Immune Globulin (VIG)

Vaccinia immune globulin (VIG) is released from the CDC Strategic National Stockpile, if indicated, for the treatment of complications associated with vaccinia vaccination. Clinicians wishing to obtain VIG should contact the Emergency Operations Center (EOC) at 770-488-7100. They will be connected with CDC medical staff who can assist them in the diagnosis and management of patients with suspected complications of vaccinia vaccination.

*this list is not all-inclusive

Use of trade names is for identification only and does not imply endorsement by the U.S. Department of Health and Human Services.


WHO: Fact sheets relating to NTD

WHO

WHO maintains a complete list of fact sheets.


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