Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00231322
Status:
COMPLETED
Last Update Posted:
2007-04-20
First Post:
2005-09-30
Brief Title:
Influence of Transmission Season on Outcome of Treatment of Schistosoma Haematobium Infection in Mozambique
Sponsor:
DBL -Institute for Health Research and Development
Organization:
DBL -Institute for Health Research and Development
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 FebruaryMach 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 girlsExaminations will include urine for parasitology and haematuria and ultrasonography of upper and lower urinary tract
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 FebruaryMach 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 girlsExaminations will include urine for parasitology and haematuria and ultrasonography of upper and lower urinary tract
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None