Clinical Trial: Urinary Schistosomiasis Infection
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Village Surveys of Morbidity Due to S. Haematobium for 1U01AI4547 Urinary Schistosomiasis-Determinants of Infection and Disease
Brief Summary: The purpose of this study is to determine what causes some people to become sick, and others not, when they are infected with the parasite Schistosoma haematobium, also known as Bilharzia. This is an infection of the urinary tract blood vessels and can cause serious disease. Approximately 4400 adults and children of any age will participate in this study. They must be residents of the Msambweni Area, Kwale District, Coast Province, Kenya, where infection with S. haematobium parasites are common. To find out if people are infected, they will first provide 1 or more urine samples for a microscope examination to detect if the S. haematobium parasites are present in the body. Volunteers then will be examined by ultrasound to see if they have kidney or bladder disease. (Ultrasound examination is the use of a non-painful machine that uses sound waves to examine the condition of the internal organs.) Treatment with the drug praziquantel will be offered if S. haematobium infection is found.
Detailed Summary: The goal of this project is to focus both field and laboratory research on specific epidemiological, genetic and immunological features that underline the greatest susceptibility to S. haematobium infection and disease. This information, combined with epidemiological modeling of control strategies, will allow accelerated synthesis of the next generation of control programs. The studies in this initial Protocol A involve a large-scale survey of study villages to determine current population demography, general health, infection with S. haematobium, and, specifically, prevalence of parasite-related morbidity. Once evaluated, participants in Protocol A may be subsequently enrolled in Project Protocols B through F if they meet inclusion criteria. The size of the observational Protocol A study cohort (~4,400) is, in part, based on one of its secondary aims: i.e., the need to identify sufficient numbers of morbidity-concordant sibling pairs for genetic studies performed under Protocol D, and sufficient mother-infant pairs for Protocol F. Beyond initial screening, no further investigation occurs in Protocol A per se. Standard doses of praziquantel therapy will be given to treat S. haematobium infection diagnosed under Protocol A. Longitudinal follow-up of a subset of these treated individuals will be performed in Protocols B, C and E of the project. The study will enroll approximately 1100 adults and 1100 children from each of 2 types of rural S. haematobium-endemic village: a) those that have had prior participation in schistosomiasis control programs (1984-1993) and b) those that have not. The Msambweni area of Kwale District in southern Coast Province, Kenya will serve as the 'previously-treated' area. This area has participated in a long-term study of S. haematobium treatment since 1983. Three additional area villages (population ~4,000) that have not previously participated in treatment programs will be included as control 'previously-untreated' areas for comparison p
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
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Information By: National Institute of Allergy and Infectious Diseases (NIAID)
Dates:
Date Received: August 26, 2005
Date Started:
Date Completion: November 2004
Last Updated: August 26, 2010
Last Verified: March 2007
