NCT00138450

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,400

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 30, 2005

Completed
Last Updated

January 30, 2019

Status Verified

March 1, 2007

First QC Date

August 26, 2005

Last Update Submit

January 28, 2019

Conditions

Keywords

Schistosomiasis, S. haematobium, morbidity, Kenya

Eligibility Criteria

AgeUp to 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KEMRI Centre for Geographic Medicine Research

Kilifi, Kenya

Location

MeSH Terms

Conditions

Urologic DiseasesSchistosomiasis haematobiaSchistosomiasis

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesTrematode InfectionsHelminthiasisParasitic DiseasesInfectionsUrinary Tract InfectionsVector Borne Diseases

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

August 26, 2005

First Posted

August 30, 2005

Study Completion

November 1, 2004

Last Updated

January 30, 2019

Record last verified: 2007-03

Locations