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

Primary Purpose

Hematuria, Hydronephrosis

Status
Completed
Phase
Not Applicable
Locations
Mozambique
Study Type
Interventional
Intervention
praziquantel
Sponsored by
DBL -Institute for Health Research and Development
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematuria focused on measuring Schistosoma haematobium, haematuria, ultrasonography, Uganda, Vesical polyps

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Matola

Outcomes

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);

Full Information

First Posted
September 30, 2005
Last Updated
April 19, 2007
Sponsor
DBL -Institute for Health Research and Development
Collaborators
Durban University of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT00231322
Brief Title
Influence of Transmission Season on Outcome of Treatment of Schistosoma Haematobium Infection in Mozambique
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
DBL -Institute for Health Research and Development
Collaborators
Durban University of Technology

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematuria, Hydronephrosis
Keywords
Schistosoma haematobium, haematuria, ultrasonography, Uganda, Vesical polyps

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
520 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
praziquantel
Primary Outcome Measure Information:
Title
cure rate
Title
egg reduction rate
Title
re-infection prevalence and intensity of infection *resolution of urinary tract pathology
Title
re-appearance of pathology after re-infection.
Secondary Outcome Measure Information:
Title
reduction in worm burden (CAA);

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerito Augusto, Msc
Organizational Affiliation
Instituto Nacional de Saúde
Official's Role
Principal Investigator
Facility Information:
Facility Name
Matola
City
Maputo
State/Province
Maputo Province
Country
Mozambique

12. IPD Sharing Statement

Links:
URL
http://www.dblnet.dk
Description
Related Info

Learn more about this trial

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

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