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Evaluation of Praziquantel Dosage for Treatment of Schistosomiasis in Brazil

NCT00403611 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2015-06-17

No results posted yet for this study

Summary

The primary objective of this project is to evaluate the efficacy and safety of praziquantel 60 mg/kg in the treatment of schistosomiasis, as compared to the standard 40 mg/kg therapy in a representative community from a highly endemic area of schistosomiasis in Northeastern Brazil. Cure rates, reduction in egg counts and proportions of reported side-effects in children at the 10-19 y age-range with at least 100 eggs per gram of faeces will be compared between regimens, aiming to evaluate the superiority of 60 mg/kg over the 40mg/kg dose currently recommended by the WHO. Reinfection rates will also be evaluated aiming to improve transmission control within the local health system, including re-treatment combined with auxiliary control measures. Features related to the clinical, nutritional and immunological status of the patients prior to treatment will also be investigated in association with the outcome of praziquantel treatment.

Conditions

  • Schistosomiasis Mansoni

Interventions

DRUG

Praziquantel 60 mg/kg

Praziquantel (Distocide) 60 mg/kg single oral dose

DRUG

Praziquantel 40 mg/kg

Praziquantel (Distocide) 40 mg/kg single oral dose

Sponsors & Collaborators

  • World Health Organization

    collaborator OTHER

  • Universidade Federal de Pernambuco

    collaborator OTHER

  • Oswaldo Cruz Foundation

    lead OTHER

Principal Investigators

  • Otavio S Pieri, PhD · Fundação Oswaldo Cruz

  • Ana Lucia C Domingues, MD · Universidade Federal de Pernambuco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2007-10-31
Completion
2008-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00403611 on ClinicalTrials.gov