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Diseases of the Urinary SystemNCT00138450

Urinary Schistosomiasis Infection

An observational study of Diseases of the Urinary System and Schistosomiasis Haematobia, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 99 yearsHealthy volunteers can take part
How many people
4,400 participants
Where
1 siteKenya
Study dates
Start not givento Nov 2004
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Kenya1 site
  • KEMRI Centre for Geographic Medicine Research

    Kilifi

Other trials in Kenya

About this study

Official title: Village Surveys of Morbidity Due to S. Haematobium for 1U01AI4547 Urinary Schistosomiasis-Determinants of Infection and Disease

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.

Read the 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 (~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 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).

Keywords
Schistosomiasis, S. haematobium, morbidity, Kenya
Medical subject headings
Urologic Diseases, Schistosomiasis haematobia, Schistosomiasis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2005 (estimated)
  2. Study completionNov 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
4,400 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00138450
Sponsor's protocol ID
01-588
Status last verified
Mar 2007
First submitted
26 Aug 2005
Last updated
30 Jan 2019
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Diseases of the Urinary System and Schistosomiasis Haematobia, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Kenya.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019.

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