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| Sponsors and Collaborators: |
University of Aarhus Statens Serum Institut |
|---|---|
| Information provided by: | University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT00713999 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Sexually Transmitted Infections Schistosoma Haematobium |
Drug: Treatment with anti-STI and anti-schistosoma regimens |
| Study Type: | Interventional |
| Study Design: | Open Label, Uncontrolled, Single Group Assignment |
| Official Title: | Study of Reproductive Health in Rural Madagascar With Emphasis on Urogenital Schistosomiasis and Sexually Transmitted Infections |
| Enrollment: | 680 |
| Study Start Date: | August 2001 |
| Study Completion Date: | September 2003 |
| Primary Completion Date: | April 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
STI/PZQ 1: Experimental
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
|
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:
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.
Eligibility| Ages Eligible for Study: | 15 Years to 49 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Madagascar | |
| Institut Pasteur | |
| Antananarivo, Madagascar, 100 | |
| Principal Investigator: | Peter DC Leutscher, MD, PhD | Danish Bilharziasis Laboratory |
More Information
| Responsible Party: | Danish Bilharziasis Laboratory ( Peter Derek Christian Leutscher, MD,PhD ) |
| Study ID Numbers: | IPM/DBL 01, RFU 1008600437 |
| Study First Received: | July 8, 2008 |
| Last Updated: | July 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00713999 History of Changes |
| Health Authority: | Madagascar: Ministry of Health |
|
Sexually transmitted infections Urogenital schistosomiasis Schistosoma haematobium Reproductive health |
Pelvic examination Ultrasonography Questionnaire Madagascar |
|
Metronidazole Schistosomiasis Genital Diseases, Male Virus Diseases Genital Diseases, Female Ciprofloxacin Cefuroxime |
Cefuroxime axetil Azithromycin Sexually Transmitted Diseases Parasitic Diseases Praziquantel Helminthiasis Doxycycline |
|
Genital Diseases, Female Virus Diseases Trematode Infections Communicable Diseases Sexually Transmitted Diseases |
Schistosomiasis Parasitic Diseases Genital Diseases, Male Infection Helminthiasis |
