Clinical Trial: Influence of Transmission Season on Outcome of Treatment of Schistosoma Haematobium Infection in Mozambique

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

Official Title: The Influence of Transmission Season on Outcome of Schistosoma Haematobium Infection Treatment Among School Children in Urban and Peri-Urban Areas of Maputo and Matola, Mozambique

Brief Summary: To assess the influence of seasonal variations in Schistosoma haematobium transmission on treatment outcome (morbidity and re-infection)

Detailed Summary:

General objective To provide knowledge about the influence of transmission season (high and low) on the outcome of treatment assessed by cure rate, re-infection rate, regression and reappearance of urinary tract morbidity rate after treatment in order to optimise praziquantel treatment strategies for morbidity control in urinary schistosomiasis.

Specific objectives To determine the prevalence and intensity of Schistosoma haematobium infection before chemotherapy and compare cure rates and levels of re-infection after chemotherapy administered during high and low transmission seasons.

To assess urinary tract morbidity due to Schistosoma haematobium by ultrasonography and compare the regression and reappearance of urinary tract pathology chemotherapy administered during high and low transmission seasons.

To correlate morbidity determined by ultrasound with infection and morbidity parameters such as intensity of infection, micro- and macrohematuria, circulating cathodic antigen (CCA) in urine, proteinuria and leucocyturia and determine sensitivity, specificity and positive predictive values in relation to urinary tract morbidity.

Study design The main research question concerning the influence of transmission season on treatment outcome will be addressed in a consecutive cohort study with two separate but comparable cohorts. The first cohort will be examined and treated with praziquantel during the season with high transmission, February/Mach (group A) and the second cohort will be examined and treated during the low transmission season, in July approximately 5 months later (group B). Each cohort will be examined before treatment and 2, 6 and 18 months after treatment.

The study
Sponsor: DBL -Institute for Health Research and Development

Current Primary Outcome:

  • cure rate
  • egg reduction rate
  • re-infection prevalence and intensity of infection *resolution of urinary tract pathology
  • re-appearance of pathology after re-infection.


Original Primary Outcome:

  • *cure rate
  • *egg reduction rate
  • *re-infection prevalence and intensity of infection *resolution of urinary tract pathology
  • *re-appearance of pathology after re-infection.


Current Secondary Outcome: reduction in worm burden (CAA);

Original Secondary Outcome: Same as current

Information By: DBL -Institute for Health Research and Development

Dates:
Date Received: September 30, 2005
Date Started: March 2004
Date Completion: March 2006
Last Updated: April 19, 2007
Last Verified: April 2007