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

Hematuria Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00231322
• Other study ID #: 30/CNSB/03/624-03-0021
• Status: Completed
• Phase: N/A
• First received: September 30, 2005
• Last updated: April 19, 2007
• Start date: March 2004
• Est. completion date: March 2006

Study information

• Verified date: April 2007
• Source: DBL -Institute for Health Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mozambique:Comité Nacional de Bioetica Para a Saúde
• Study type: Interventional

Clinical Trial Summary

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

Description:

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 will be carried out in 4 primary schools; two from Machava J area and two from Costa do Sol area. The schools will be selected based on the following criteria: similar prevalence (> 50%) and intensity of S. haematobium infection; absence or very low levels of S. mansoni infection; a minimum of 2 classes (>35 pupils per class) at each level (3rd and 4th level) and similar distribution of boys and girls.Examinations will include urine for parasitology and haematuria and ultrasonography of upper and lower urinary tract

Recruitment information / eligibility

• Status: Completed
• Enrollment: 520
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria:

• children aged 8-12 years

Exclusion Criteria:

• All children presenting with macro-haematuria or severe pathology detected by ultrasonography (large masses, pseudo-polyps or hydronephrosis/hydroureter) at the 6 months follow-up examination will be treated with praziquantel and excluded in the data analysis.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hematuria
• Hydronephrosis
• Schistosomiasis haematobia

Intervention

Drug:
• praziquantel

Locations

Country	Name	City	State
Mozambique	Matola	Maputo	Maputo Province

Sponsors (2)

Lead Sponsor	Collaborator
DBL -Institute for Health Research and Development	Durban University of Technology South Africa

Country where clinical trial is conducted

Mozambique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cure rate
Primary	egg reduction rate
Primary	re-infection prevalence and intensity of infection *resolution of urinary tract pathology
Primary	re-appearance of pathology after re-infection.
Secondary	reduction in worm burden (CAA);

External Links

•   Link