Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00138450
Status:
COMPLETED
Last Update Posted:
2019-01-30
First Post:
2005-08-26
Brief Title:
Urinary Schistosomiasis Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Village Surveys of Morbidity Due to S Haematobium for 1U01AI4547 Urinary Schistosomiasis-Determinants of Infection and Disease
Status:
COMPLETED
Status Verified Date:
2007-03
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:
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 Description:
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 4400 is in part based on one of its secondary aims ie 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 4000 that have not previously participated in treatment programs will be included as control previously-untreated areas for comparison purposes to confirm the natural history of untreated infection Like Msambweni area villages the comparison villages Mbuani Mabakoni and Gonjora will be located in southern Kwale District Coast Province Kenya In order to mirror the pre-control experience of the Msambweni villages comparison villages will be selected primarily for their high S haematobium prevalence 40 as determined in prior Ministry of Health sample surveys in schools Secondary selection criteria will be village size 1200 to 2000 per village and a rural mostly agrarian environment Residents will update their demography and kinship data then receive physical examinations urinalysis ultrasound and parasitological examinations to determine infection and morbidity status Because of its size the population will be surveyed on a systematic village-by village basis over the first 2 years of the project These surveys will provide an effective cross-sectional evaluation of current levels of disease in treated and untreated communities at-large Subjects with suspicion for severe renal dysfunction or bladder cancer a known late complication of S haematobium will be referred to Msambweni or Mombasa Hospitals for further care The primary study objective is to compare 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 Secondary objectives are to 1 compare rates of heavy S haematobium infection for individuals residing in these previously-treated and -untreated villages and 2 identify eligible subjects for participation in more detailed study of late S haematobium-related disease hereditary predisposition to morbidity association of cytokine response to morbidity and effects of in utero sensitization to S haematobium on disease in later life Protocols B-F of the project
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