Influence of Transmission Season on Outcome of Treatment of Schistosoma Haematobium Infection in Mozambique
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| ClinicalTrials.gov Identifier: NCT00231322 |
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Recruitment Status :
Completed
First Posted : October 4, 2005
Last Update Posted : April 20, 2007
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hematuria Hydronephrosis | Drug: praziquantel | Not Applicable |
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 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 |
- cure rate
- egg reduction rate
- re-infection prevalence and intensity of infection *resolution of urinary tract pathology
- re-appearance of pathology after re-infection.
- reduction in worm burden (CAA);
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| Ages Eligible for Study: | 8 Years to 12 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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
| Mozambique | |
| Matola | |
| Maputo, Maputo Province, Mozambique | |
| Principal Investigator: | Gerito Augusto, Msc | Instituto Nacional de Saúde |
Additional Information:
| ClinicalTrials.gov Identifier: | NCT00231322 History of Changes |
| 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:
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Schistosoma haematobium haematuria ultrasonography Uganda Vesical polyps |
Additional relevant MeSH terms:
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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 |