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Clinical Trial Summary

A cross-sectional study of urogenital schistosomiasis and sexually transmitted infections (STI) prevalence and associated morbidity in a rural community in Madagascar. Clearance of infections and resolution of morbidity were subsequently studied in two phases following systematic anti-STI and anti-schistosoma treatment, respectively.

Clinical Trial Description

The study was conducted in the Schistosoma haematobium high-endemic SIRAMA sugarcane plantation near the Ambilobe town in the northern province of Diego Suarez in Madagascar. A neighboring low-endemic village, Mataipako, was selected a control village. Participants aged 15 to 49 years old from SIRAMA were included in the study if positive for S.haematobium egg in urine.

A questionnaire addressing previous medical history and current urogenital symptoms was applied. A physical examination, including ultrasonophical (US) examination of urinary tract by transabdominal route, was undertaken. A pelvic examination, including transvaginal US was performed in women. In men, the prostate and the seminal vesicles were examined by transrectal US.

The following sexually transmitted infections (STI) were systematically assessed:

- Neisseria gonorrheae

- Chlamydia trachomatis

- Mycoplasma genitalium

- Trichomonas

- Treponema pallidum

- Herpes simplex 1 and 2

After baseline assessment, all participants (and partners) were systematically treated with an anti-STI regimen according to the existing guidelines by the Ministry of Health in Madagascar.

Re-assessment by questionnaire, physical examination and sampling for STIs was undertaken 4 weeks later followed by systematic praziquantel treatment to general community, including study participants.

A final follow-up study following the baseline protocol was conducted 5 months later. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

NCT number NCT00713999
Study type Interventional
Source University of Aarhus
Status Completed
Phase N/A
Start date August 2001
Completion date September 2003

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