Urogenital Schistosomiasis and Sexually Transmitted Infections in Madagascar (FGS/MGS/STI)
|ClinicalTrials.gov Identifier: NCT00713999|
Recruitment Status : Completed
First Posted : July 14, 2008
Last Update Posted : July 14, 2008
|Condition or disease||Intervention/treatment||Phase|
|Sexually Transmitted Infections Schistosoma Haematobium||Drug: Treatment with anti-STI and anti-schistosoma regimens||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||680 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Reproductive Health in Rural Madagascar With Emphasis on Urogenital Schistosomiasis and Sexually Transmitted Infections|
|Study Start Date :||August 2001|
|Actual Primary Completion Date :||April 2002|
|Actual Study Completion Date :||September 2003|
Experimental: STI/PZQ 1
Baseline and post-treatment follow-up (anti-STI and praziquantel Rx)
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
Other Name: Biltricide
- Measurement of urogenital schistosomiasis and STI prevalence [ Time Frame: 2 months ]
- Urogenital and STI associated morbidity [ Time Frame: 2 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00713999
|Antananarivo, Madagascar, 100|
|Principal Investigator:||Peter DC Leutscher, MD, PhD||Danish Bilharziasis Laboratory|