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.
Full Title of Study: “Study of Reproductive Health in Rural Madagascar With Emphasis on Urogenital Schistosomiasis and Sexually Transmitted Infections”
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Study Primary Completion Date: April 2002
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
- 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.
- 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
Arms, Groups and Cohorts
- Experimental: STI/PZQ 1
- Baseline and post-treatment follow-up (anti-STI and praziquantel Rx)
Clinical Trial Outcome Measures
- Measurement of urogenital schistosomiasis and STI prevalence
- Time Frame: 2 months
- Urogenital and STI associated morbidity
- Time Frame: 2 months
Participating in This Clinical Trial
- positive Schistosoma haematobium egg excretion in urine
- signed written consensus
- negative Schistosoma haematobium egg excretion in urine
Gender Eligibility: All
Minimum Age: 15 Years
Maximum Age: 49 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- University of Aarhus
- Statens Serum Institut
- Provider of Information About this Clinical Study
- Peter Derek Christian Leutscher, MD,PhD, Danish Bilharziasis Laboratory
- Overall Official(s)
- Peter DC Leutscher, MD, PhD, Principal Investigator, Danish Bilharziasis Laboratory
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.