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

History of Changes

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:

Drug Information available for: Praziquantel

Genetic and Rare Diseases Information Center resources: Schistosomiasis Helminthiasis

U.S. FDA Resources

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 (Child)
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:

Related Info This link exits the ClinicalTrials.gov site


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:


Hydronephrosis Hematuria Schistosomiasis haematobia Kidney Diseases Urologic Diseases Urination Disorders Hemorrhage Pathologic Processes Urinary Tract Infections	Infection Schistosomiasis Trematode Infections Helminthiasis Parasitic Diseases Praziquantel Anthelmintics Antiparasitic Agents Anti-Infective Agents

ClinicalTrials.gov processed this record on September 23, 2016

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