NCT00403611

Evaluation of Praziquantel Dosage for Treatment of Schistosomiasis in Highly Endemic Areas of Northeastern Brazil

Completed Phase 4 Last updated 16 June 2015

What this trial tests

Phase 4 trial testing Praziquantel 60 mg/kg in Schistosomiasis Mansoni in 196 participants. Completed in 1 May 2008.

Timeline

1 March 2006

Primary endpoint
1 October 2007

1 May 2008

Quick facts

Lead sponsor	Oswaldo Cruz Foundation
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	196
Start date	1 March 2006
Primary completion	1 October 2007
Estimated completion	1 May 2008

Drugs / interventions tested

• Praziquantel 60 mg/kg — full drug profile →
• Praziquantel 40 mg/kg — full drug profile →

Conditions studied

• Schistosomiasis Mansoni — all drugs for Schistosomiasis Mansoni →

Sponsor

Oswaldo Cruz Foundation

Who can join

Adults 10 to 19, any sex, with Schistosomiasis Mansoni. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Cure rate and egg reduction rate at twenty-one days after treatment
  Time frame: 21 days

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A multicentre randomized controlled trial of the efficacy and safety of single-dose praziquantel at 40 mg/kg vs. 60 mg/kg for treating intestinal schistosomiasis in the Philippines, Mauritania, Tanzania and Brazil.
   Olliaro PL, Vaillant MT, Belizario VJ, Lwambo NJ, et al · · 2011 · cited 66× · PMID 21695161 · DOI 10.1371/journal.pntd.0001165