Population Pharmacokinetics of Benznidazole in Children With Chagas Disease

Summary

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.

Conditions

• Chagas Disease

Interventions

DRUG

Benznidazole

benznidazole (RADANIL®, Roche) 5-8 mg/kg/d bid PO for 60 days

Sponsors & Collaborators

• Thrasher Research Fund

  collaborator OTHER

• The Hospital for Sick Children

  collaborator OTHER

• Fundacion Bunge y Born (Argentina)

  collaborator UNKNOWN

• Universidad Nacional de La Plata

  collaborator OTHER

• Consejo de Investigacion en Salud Gobierno de Buenos Aires

  collaborator OTHER

• Hospital de Niños R. Gutierrez de Buenos Aires

  lead OTHER

Principal Investigators

• Jaime Altcheh, MD · Parasitology Service, Children's Hospital "R. Gutierrez" of Buenos Aires

• Facundo Garcia Bournissen, MD · Division of Clinical Pharmacology & Toxicology, Hospital for Sick Children, University of Toronto

• Norberto Giglio, MD · Epidemiology Service, Children's Hospital "R. Gutierrez" of Buenos Aires

• Gideon Koren, MD · Division of Clinical Pharmacology &Toxicology, Hospital for Sick Children, University of Toronto

• Oscar Della Vedova · Universidad Nacional de La Plata

• Guido Mastrantonio · Facultad de Ciencias Exactas, Universidad Nacional de La Plata

Study Design

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

2 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-04-30

Primary Completion

2011-05-31

Completion

2011-05-31

Countries

• Argentina