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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00231322
Other study ID # 30/CNSB/03/624-03-0021
Secondary ID
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
Est. primary completion date
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


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);
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