This protocol is intended to provide a cross-sectional survey of the level of severe disease and heavy infection in the S. haematobium-endemic area of southern Kwale District, Kenya. The primary purpose is to determine the impact of prior school-age therapy on the natural history of disease due to urinary schistosomiasis

Condition
Diseases of the Urinary System

Further Study Details: 

Expected Total Enrollment:  4400

The primary study objective is to compare the rates of moderate-to-severe urinary tract morbidity associated with S.haematobium infection for older children and adults residing in previously-treated and previously-untreated villages in the endemic southern Kwale District, Coast Province, Kenya. and to compare the rates of heavy S. haematobium infection for individuals residing in these previously-treated and untreated villages. And to identify subjects for participation in more detailed study of late S. haematobium-related disease, hereditary predisposition to morbidity, the association of cytokine response to morbidity and the effects of in utero sensitization to S. haematobium on disease in later life.

Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

Inclusion Criteria:

1. Kenyan residents, newborn to adult, either male or female.
2. Residence in areas of Kwale District endemic for Schistosoma haematobium

Exclusion Criteria:

Exclusion Criteria:

Pregnancy. (this is a partial exclusion) Pregnant women will participate in the parasitological screening phase of the study. However, because of pregnancy-related effects on the urinary system, their ultrasound examinations will be excluded from the analysis of hydronephrosis. Further, because of potential toxicity of praziquantel (Category B) and its alternative, metrifonate (an anticholinesterase), post-protocol anti-parasitic therapy will be delayed until the mother delivers and has stopped breastfeeding her infant.

Kenya
      KEMRI Centre for Geographic Medicine Research, Kilifi,  Kenya

Study ID Numbers:  01-588
Last Updated:  September 12, 2005
Record first received:  August 26, 2005
ClinicalTrials.gov Identifier:  NCT00138450
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-13