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Influence of Transmission Season on Outcome of Treatment of Schistosoma Haematobium Infection in Mozambique
This study has been completed.
Study NCT00231322   Information provided by DBL -Institute for Health Research and Development
First Received: September 30, 2005   Last Updated: April 19, 2007   History of Changes

September 30, 2005
April 19, 2007
March 2004
 
  • cure rate
  • egg reduction rate
  • re-infection prevalence and intensity of infection *resolution of urinary tract pathology
  • re-appearance of pathology after re-infection.
  • *cure rate
  • *egg reduction rate
  • *re-infection prevalence and intensity of infection *resolution of urinary tract pathology
  • *re-appearance of pathology after re-infection.
Complete list of historical versions of study NCT00231322 on ClinicalTrials.gov Archive Site
reduction in worm burden (CAA);
Same as current
 
Influence of Transmission Season on Outcome of Treatment of Schistosoma Haematobium Infection in Mozambique
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

 
Interventional
Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
  • Hematuria
  • Hydronephrosis
Drug: praziquantel
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
520
March 2006
 

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.
Both
8 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
Mozambique
 
NCT00231322
 
30/CNSB/03/624-03-0021
DBL -Institute for Health Research and Development
Durban University of Technology South Africa
Principal Investigator: Gerito Augusto, Msc Instituto Nacional de Saúde
DBL -Institute for Health Research and Development
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP