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

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ClinicalTrials.gov Identifier: NCT00231322
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : April 20, 2007
Sponsor:
Collaborator:
Durban University of Technology
Information provided by:
DBL -Institute for Health Research and Development

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

Condition or disease Intervention/treatment Phase
Hematuria Hydronephrosis Drug: praziquantel Not Applicable

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 520 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2004
Study Completion Date : March 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. cure rate
  2. egg reduction rate
  3. re-infection prevalence and intensity of infection *resolution of urinary tract pathology
  4. re-appearance of pathology after re-infection.

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

Eligibility Criteria
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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00231322


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

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ClinicalTrials.gov Identifier: NCT00231322    
Other Study ID Numbers: 30/CNSB/03/624-03-0021
First Posted: October 4, 2005    Key Record Dates
Last Update Posted: April 20, 2007
Last Verified: April 2007
Keywords provided by DBL -Institute for Health Research and Development:
Schistosoma haematobium
haematuria
ultrasonography
Uganda
Vesical polyps
Additional relevant MeSH terms:
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Schistosomiasis haematobia
Hematuria
Hydronephrosis
Infections
Urination Disorders
Urologic Diseases
Hemorrhage
Pathologic Processes
Kidney Diseases
Schistosomiasis
 Trematode Infections
Helminthiasis
Parasitic Diseases
Urinary Tract Infections
Vector Borne Diseases
Praziquantel
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents