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Population Pharmacokinetics of Benznidazole in Children With Chagas Disease

Primary Purpose

Chagas Disease

Status
Completed
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Benznidazole
Sponsored by
Hospital de Niños R. Gutierrez de Buenos Aires
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chagas Disease focused on measuring Chagas disease, Pediatrics, benznidazole, population pharmacokinetics, neglected diseases, parasitology, pediatric clinical pharmacology

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Benznidazole

Arm Description

Treatment of pediatric Chagas disease with benznidazole

Outcomes

Primary Outcome Measures

Description of Population pharmacokinetics parameters of benznidazole (i.e. median population clearance, absorption and volume of distribution, and their respective inter-individual variabilities)

Secondary Outcome Measures

Adverse events

Full Information

First Posted
June 16, 2008
Last Updated
July 29, 2011
Sponsor
Hospital de Niños R. Gutierrez de Buenos Aires
Collaborators
Thrasher Research Fund, The Hospital for Sick Children, Fundacion Bunge y Born (Argentina), Universidad Nacional de La Plata, Consejo de Investigacion en Salud Gobierno de Buenos Aires
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1. Study Identification

Unique Protocol Identification Number
NCT00699387
Brief Title
Population Pharmacokinetics of Benznidazole in Children With Chagas Disease
Official Title
Population Pharmacokinetics Study of Benznidazole in Children With Chagas Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital de Niños R. Gutierrez de Buenos Aires
Collaborators
Thrasher Research Fund, The Hospital for Sick Children, Fundacion Bunge y Born (Argentina), Universidad Nacional de La Plata, Consejo de Investigacion en Salud Gobierno de Buenos Aires

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chagas Disease
Keywords
Chagas disease, Pediatrics, benznidazole, population pharmacokinetics, neglected diseases, parasitology, pediatric clinical pharmacology

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Benznidazole
Arm Type
Experimental
Arm Description
Treatment of pediatric Chagas disease with benznidazole
Intervention Type
Drug
Intervention Name(s)
Benznidazole
Other Intervention Name(s)
Children with Chagas Disease Treated with Benznidazole, Niños con Chagas en Tratamiento con Benznidazol
Intervention Description
benznidazole (RADANIL®, Roche) 5-8 mg/kg/d bid PO for 60 days
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
Adverse events
Time Frame
2 months (treatment period)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaime Altcheh, MD
Organizational Affiliation
Parasitology Service, Children's Hospital "R. Gutierrez" of Buenos Aires
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Facundo Garcia Bournissen, MD
Organizational Affiliation
Division of Clinical Pharmacology & Toxicology, Hospital for Sick Children, University of Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Norberto Giglio, MD
Organizational Affiliation
Epidemiology Service, Children's Hospital "R. Gutierrez" of Buenos Aires
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gideon Koren, MD
Organizational Affiliation
Division of Clinical Pharmacology &Toxicology, Hospital for Sick Children, University of Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Oscar Della Vedova
Organizational Affiliation
Universidad Nacional de La Plata
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guido Mastrantonio
Organizational Affiliation
Facultad de Ciencias Exactas, Universidad Nacional de La Plata
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires
City
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina

12. IPD Sharing Statement

Citations:
PubMed Identifier
24853169
Citation
Altcheh J, Moscatelli G, Mastrantonio G, Moroni S, Giglio N, Marson ME, Ballering G, Bisio M, Koren G, Garcia-Bournissen F. Population pharmacokinetic study of benznidazole in pediatric Chagas disease suggests efficacy despite lower plasma concentrations than in adults. PLoS Negl Trop Dis. 2014 May 22;8(5):e2907. doi: 10.1371/journal.pntd.0002907. eCollection 2014 May.
Results Reference
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Population Pharmacokinetics of Benznidazole in Children With Chagas Disease

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