NCT00713999

Urogenital Schistosomiasis and Sexually Transmitted Infections in Madagascar

Study of Reproductive Health in Rural Madagascar With Emphasis on Urogenital Schistosomiasis and Sexually Transmitted Infections

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 680 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 15 Years – 49 Years
• Healthy volunteers: Accepted

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.

Conditions

• Sexually Transmitted Infections
• Schistosoma Haematobium

Interventions

Type	Name	Description
DRUG	Treatment with anti-STI and anti-schistosoma regimens	Anti-STI regimen: ciprofloxacin 500mg orally, doxycycline 100mg BID orally 7 days and metronidazole 2g orally (cefuroxime im and/or azithromycin alternatively for pregnant and breastfeeding women) Anti-schistosoma regimen: Praziquantel 40mg/kg

Timeline

• Start date: 2001-08-01
• Primary completion: 2002-04-01
• Completion: 2003-09-01
• First posted: 2008-07-14
• Last updated: 2008-07-14

Locations

1 site across 1 country: Madagascar