Chagas DiseaseNCT00699387
Population Pharmacokinetics of Benznidazole in Children With Chagas Disease
A study testing Benznidazole in people with Chagas Disease, run by Hospital de Niños R. Gutierrez de Buenos Aires at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Chagas Disease
- What is being tested?
- Benznidazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteArgentina
- Study dates
- Apr 2007to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires
Buenos Aires, Buenos Aires, 1425
About this study
Official title: Population Pharmacokinetics Study of Benznidazole in Children With Chagas Disease
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.
Read more
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
- Being tested
- Benznidazole
- Keywords
- Chagas disease, Pediatrics, benznidazole, population pharmacokinetics, neglected diseases, parasitology, pediatric clinical pharmacology
- Medical subject headings
- Chagas Disease, Neglected Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BenznidazoleDrug
Also called Children with Chagas Disease Treated with Benznidazole, Niños con Chagas en Tratamiento con Benznidazol
benznidazole (RADANIL®, Roche) 5-8 mg/kg/d bid PO for 60 days
| Study group | Role | What they receive |
|---|---|---|
| Benznidazole | Experimental | Treatment of pediatric Chagas disease with benznidazole Receives: Drug: Benznidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of Population pharmacokinetics parameters of benznidazole (i.e. median population clearance, absorption and volume of distribution, and their respective inter-individual variabilities)
Measured: 2 months (treatment period)
Secondary outcomes (1)
Adverse events
Measured: 2 months (treatment period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startApr 2007
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chagas DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Niños R. Gutierrez de Buenos Aires
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Jaime Altcheh, MD, Study director, Parasitology Service, Children's Hospital "R. Gutierrez" of Buenos AiresFacundo Garcia Bournissen, MD, Principal investigator, Division of Clinical Pharmacology & Toxicology, Hospital for Sick Children, University of TorontoNorberto Giglio, MD, Principal investigator, Epidemiology Service, Children's Hospital "R. Gutierrez" of Buenos AiresGideon Koren, MD, Principal investigator, Division of Clinical Pharmacology &Toxicology, Hospital for Sick Children, University of TorontoOscar Della Vedova, Principal investigator, Universidad Nacional de La PlataGuido Mastrantonio, Principal investigator, Facultad de Ciencias Exactas, Universidad Nacional de La Plata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00699387
- Sponsor's protocol ID
- CHAGAS-CHILDREN-POPPK
- Status last verified
- Jul 2011
- First submitted
- 16 Jun 2008
- Last updated
- 1 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24853169
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetics Study of Benznidazole in Children With Chagas Disease
- ClinicalTrials.gov ID
- NCT00699387
- Acronym / sponsor ID
- CHAGAS-CHILDREN-POPPK
- Conditions
- Chagas Disease
- Keywords
- Chagas disease, Pediatrics, benznidazole, population pharmacokinetics, neglected diseases, parasitology, pediatric clinical pharmacology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Hospital de Niños R. Gutierrez de Buenos AiresUniversity, hospital or other
- 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
- Study start
- Apr 2007
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 18 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Benznidazole | Experimental | Drug: BenznidazoleTreatment of pediatric Chagas disease with benznidazole |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BenznidazoleAlso: Children with Chagas Disease Treated with Benznidazole, Niños con Chagas en Tratamiento con Benznidazolbenznidazole (RADANIL®, Roche) 5-8 mg/kg/d bid PO for 60 days | Drug | Benznidazole |
Primary outcome
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)
1 secondary outcome
Adverse events
Time frame: 2 months (treatment period)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2011.
- Derived from this study: PubMed 24853169Altcheh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaime Altcheh, MD study director
Parasitology Service, Children's Hospital "R. Gutierrez" of Buenos Aires
Facundo Garcia Bournissen, MD principal investigator
Division of Clinical Pharmacology & Toxicology, Hospital for Sick Children, University of Toronto
Norberto Giglio, MD principal investigator
Epidemiology Service, Children's Hospital "R. Gutierrez" of Buenos Aires
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Benznidazole in people with Chagas Disease, run by Hospital de Niños R. Gutierrez de Buenos Aires at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00699387, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2011.