Urogenital Schistosomiasis and Sexually Transmitted Infections in Madagascar

Not Applicable

Completed

• Conditions: Sexually Transmitted Infections; Schistosoma Haematobium
• Interventions: Drug: Treatment with anti-STI and anti-schistosoma regimens

• Registration Number: NCT00713999
• Lead Sponsor: University of Aarhus

Brief 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.

Detailed 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 Timeline

• Study Start: 2001-08
• Primary Completion: 2002-04
• Study Completion: 2003-09
• Status Verified: 2008-07
• Study First Submitted: 2008-07-08
• Study First Submitted QC: 2008-07-11
• Last Update Submitted: 2008-07-11
• Study First Posted: 2008-07-14
• Last Update Posted: 2008-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 680

Inclusion Criteria

• adults
• positive Schistosoma haematobium egg excretion in urine
• signed written consensus

Exclusion Criteria

• children
• negative Schistosoma haematobium egg excretion in urine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
STI/PZQ 1	Treatment with anti-STI and anti-schistosoma regimens	Baseline and post-treatment follow-up (anti-STI and praziquantel Rx)

Primary Outcome Measures

Name	Time	Method
Measurement of urogenital schistosomiasis and STI prevalence	2 months

Secondary Outcome Measures

Name	Time	Method
Urogenital and STI associated morbidity	2 months

Trial Locations

Locations (1)

Institut Pasteur; 🇲🇬 Antananarivo, Madagascar