Clinical Trial: Evaluation of Praziquantel Dosage for Treatment of Schistosomiasis in Brazil

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:

This is a double blind, randomized, PZQ 40mg/Kg- controlled clinical trial. Subjects 10-19 years old living in communities of the Northeast of Brazil will be identified and invited to participate in this study.

Well trained field health agents will first make a sketch map of the village (depicting the location of houses, main water courses, snail habitats and water-contact sites) and apply a household questionnaire to obtain personal data from residents to identify the individuals in the 10-19 years age range, as well as to record sanitary standards of the houses and water-contact reported behaviour as described by Pieri et al. (1998, Mem. Inst. Oswaldo Cruz, 93, Suppl 1: 259-264).

Meetings with the Caricé Community Association will be held in order to explain to the inhabitants the purpose, the objectives of the study, and how the study will be conducted.

Thereafter, all residents between 10 and 19 yrs of age will be interviewed at their homes regarding the fulfilment of the inclusion/exclusion criteria. Those who fulfil the criteria and agree to participate in the screening phase of the trial (signed Screening Informed Consent) will be given stool vials and asked to provide stool samples (two samples within 5-day intervals) that will be collected at their homes in the following days, stored in heat-proof containers and taken to the premises of the Service of Reference for Schistosomiasis Diagnosis of the CPqAM to be promptly prepared for examination by the Kato-Katz method (Katz et al, 1972, Rev. Inst. Med. Trop. Sao Paulo, 14: 397-400) aiming to identify positive cases and estimate individual egg load. Females on childbearing age will also be asked to provide a urine sample for pregnancy test. Pregnant women will only be treated with Praziquantel after weaning, as c
Sponsor: Oswaldo Cruz Foundation

Current Primary Outcome: Cure rate and egg reduction rate at twenty-one days after treatment [ Time Frame: 21 days ]

Original Primary Outcome:

  • Cure rate and egg reduction rate at twenty-one days after treatment
  • Reinfection rate and Egg reduction rate at six and twelve months after treatment


Current Secondary Outcome:

  • Occurrence of the following symptoms following praziquantel administration: abdominal pain, diarrhea, vomiting, nausea, drowsiness, general malaise, edema, skin rash, urticaria, myalgia, heartburn, fever, dizziness and headache. [ Time Frame: 21 days ]
  • Weight (Kg) and height (m) measured at Day 0, 6 months and 12 months follow-up visits. [ Time Frame: 12 months ]
  • Presence/absence of periportal fibrosis and liver or spleen enlargement at Day 0, 6 months and 12 months follow-up visits. [ Time Frame: 12 months ]
  • Factors associated with cure/failure at Day 21 evaluation: [ Time Frame: 21 days ]
  • Haematological: Haemoglobin/ Hematocrit, leukocytes count, lymphocytes and eosinophiles count. [ Time Frame: 0 days ]
  • Biochemistry: liver function will be evaluated by serum bilirubin, alkaline phosphatase, aspartate aminotransferase, and alamin aminotransferase levels. [ Time Frame: 0 days ]
  • Immunological: Titles of anti-SEA and anti-SWAB antibodies. [ Time Frame: 0 days ]
  • Reinfection rate and Egg reduction rate at six and twelve months after treatment [ Time Frame: 12 months ]


Original Secondary Outcome:

  • Occurrence of the following symptoms following praziquantel administration: abdominal pain, diarrhea, vomiting, nausea, drowsiness, general malaise, edema, skin rash, urticaria, myalgia, hearthburn, fever, dizziness and headache.
  • Weight (Kg) and height (m) measured at Day 0, 6 months and 12 months follow-up visits.
  • Presence/absence of periportal fibrosis and liver or spleen enlargement at Day 0, 6 months and 12 months follow-up visits.
  • Factors associated with cure/failure at Day 21 evaluation:
  • Haematological: Haemoglobin/ Hematocrit, leukocytes count, lymphocytes and eosynophyles count.
  • Biochemistry: liver function will be evaluated by serum bilirubin, alkaline phosphatase, asparte aminotransferase, and alamine aminotransferase levels.
  • Immunological: Titles of anti-SEA and anti-SWAB antibodies.
  • Periportal fibrosis and liver/spleen enlargement


Information By: Oswaldo Cruz Foundation

Dates:
Date Received: November 24, 2006
Date Started: March 2006
Date Completion:
Last Updated: June 16, 2015
Last Verified: June 2015