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

This study has been completed.
Sponsor:
Collaborator:
Durban University of Technology South Africa
Information provided by:
DBL -Institute for Health Research and Development
ClinicalTrials.gov Identifier:
NCT00231322
First received: September 30, 2005
Last updated: April 19, 2007
Last verified: April 2007
  Purpose

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


Condition Intervention
Hematuria
Hydronephrosis
Drug: praziquantel

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

Resource links provided by NLM:


Further study details as provided by DBL -Institute for Health Research and Development:

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

Secondary Outcome Measures:
  • reduction in worm burden (CAA);

Estimated Enrollment: 520
Study Start Date: March 2004
Estimated Study Completion Date: March 2006
Detailed 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

  Eligibility

Ages Eligible for Study:   8 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00231322

Locations
Mozambique
Matola
Maputo, Maputo Province, Mozambique
Sponsors and Collaborators
DBL -Institute for Health Research and Development
Durban University of Technology South Africa
Investigators
Principal Investigator: Gerito Augusto, Msc Instituto Nacional de Saúde
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00231322     History of Changes
Other Study ID Numbers: 30/CNSB/03/624-03-0021
Study First Received: September 30, 2005
Last Updated: April 19, 2007
Health Authority: Mozambique:Comité Nacional de Bioetica Para a Saúde

Keywords provided by DBL -Institute for Health Research and Development:
Schistosoma haematobium
haematuria
ultrasonography
Uganda
Vesical polyps

Additional relevant MeSH terms:
Hematuria
Hydronephrosis
Schistosomiasis haematobia
Helminthiasis
Hemorrhage
Infection
Kidney Diseases
Parasitic Diseases
Pathologic Processes
Schistosomiasis
Trematode Infections
Urinary Tract Infections
Urination Disorders
Urologic Diseases
Praziquantel
Anthelmintics
Anti-Infective Agents
Antiparasitic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014