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
To assess the influence of seasonal variations in Schistosoma haematobium transmission on treatment outcome (morbidity and re-infection)
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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