Population Pharmacokinetics of Benznidazole in Children With Chagas Disease
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Purpose
Background: Chagas disease is a parasitic infection caused by the Trypanosome cruzi. The initial phase of the infection happens mainly in children. Up to 10% of infected children die. Survivors often develop chronic infection leading to heart disease and other complications in 30% of patients. These complications often result in death or severe handicaps in early adulthood, depriving societies of individuals in their most productive years.
There are 20 million people infected in Latin America. Complications lead to 20,000 deaths every year.
Treatment during the acute phase with benznidazole leads to a high cure rate. However, there are very few studies of this drug and virtually none in children, even though benznidazole was developed over 30 years ago.
Hypotheses and Specific Aims: We hypothesize that the pharmacokinetics of benznidazole in children is different from adults, and that obtaining information on how it is absorbed, distributed and eliminated in children will allow optimization of treatment of Chagas disease in this population. This will in turn improve the outlook for children by reducing mortality and long term complications. We aim to study the pharmacokinetics of benznidazole in children receiving the drug for treatment of Chagas disease, and to correlate it with treatment effectiveness and incidence of adverse effects.
Potential Impact: This novel knowledge will allow better and more rational approaches to the treatment of Chagas disease. It will also set the foundation for further studies that will be able to test improved therapies that may increase treatment response in vulnerable children.
| Condition | Intervention |
|---|---|
|
Chagas Disease |
Drug: Benznidazole |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Population Pharmacokinetics Study of Benznidazole in Children With Chagas Disease |
- Description of Population pharmacokinetics parameters of benznidazole (i.e. median population clearance, absorption and volume of distribution, and their respective inter-individual variabilities) [ Time Frame: 2 months (treatment period) ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: 2 months (treatment period) ] [ Designated as safety issue: Yes ]
| Enrollment: | 37 |
| Study Start Date: | April 2007 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Benznidazole
Treatment of pediatric Chagas disease with benznidazole
|
Drug: Benznidazole
benznidazole (RADANIL®, Roche) 5-8 mg/kg/d bid PO for 60 days
Other Names:
|
Eligibility| Ages Eligible for Study: | 2 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Children 2 - 12 years old of both sexes, with a diagnosis of Chagas' disease and eligible for treatment with benznidazole, as per current treatment protocols.
- Chagas disease diagnostic criteria: At least 2 positive serological tests for Trypanosoma cruzi infection (ELISA, hemoagglutination, particle agglutination tests).
- Informed consent signed by the parents, and consent or assent of the patients (according to age and consenting capacity).
Exclusion Criteria:
- Patients with a history of hypersensitivity to benznidazole or any of the drug excipients
- Immunocompromised patients
- Altered hepatic function (increase in AST/ALT x3 or bilirubin x3) or altered renal function (increase in creatinine x3)
- Pregnancy
Contacts and Locations| Argentina | |
| Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires | |
| Buenos Aires, Argentina, 1425 | |
| Study Director: | Jaime Altcheh, MD | Parasitology Service, Children's Hospital "R. Gutierrez" of Buenos Aires |
| Principal Investigator: | Facundo Garcia Bournissen, MD | Division of Clinical Pharmacology & Toxicology, Hospital for Sick Children, University of Toronto |
| Principal Investigator: | Norberto Giglio, MD | Epidemiology Service, Children's Hospital "R. Gutierrez" of Buenos Aires |
| Principal Investigator: | Gideon Koren, MD | Division of Clinical Pharmacology &Toxicology, Hospital for Sick Children, University of Toronto |
| Principal Investigator: | Oscar Della Vedova | Universidad Nacional de La Plata |
| Principal Investigator: | Guido Mastrantonio | Facultad de Ciencias Exactas, Universidad Nacional de La Plata |
More Information
No publications provided
| Responsible Party: | Dr Jaime Altcheh, Servicio de Parasitología, Hospital de Niños "R Gutiérrez" de Buenos Aires |
| ClinicalTrials.gov Identifier: | NCT00699387 History of Changes |
| Other Study ID Numbers: | CHAGAS-CHILDREN-POPPK |
| Study First Received: | June 16, 2008 |
| Last Updated: | July 29, 2011 |
| Health Authority: | Argentina: Human Research Bioethics Committee Argentina: Ministry of Health Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
Keywords provided by Hospital de Niños R. Gutierrez de Buenos Aires:
|
Chagas disease Pediatrics benznidazole population pharmacokinetics |
neglected diseases parasitology pediatric clinical pharmacology |
Additional relevant MeSH terms:
|
Chagas Disease Trypanosomiasis Euglenozoa Infections Protozoan Infections Parasitic Diseases Benzonidazole Immunosuppressive Agents Immunologic Factors |
Physiological Effects of Drugs Pharmacologic Actions Trypanocidal Agents Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013