Urogenital Schistosomiasis and Sexually Transmitted Infections in Madagascar (FGS/MGS/STI)
| Tracking Information | |||||
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| First Received Date ICMJE | July 8, 2008 | ||||
| Last Updated Date | July 11, 2008 | ||||
| Start Date ICMJE | August 2001 | ||||
| Primary Completion Date | April 2002 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Measurement of urogenital schistosomiasis and STI prevalence [ Time Frame: 2 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00713999 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Urogenital and STI associated morbidity [ Time Frame: 2 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Urogenital Schistosomiasis and Sexually Transmitted Infections in Madagascar | ||||
| Official Title ICMJE | Study of Reproductive Health in Rural Madagascar With Emphasis on Urogenital Schistosomiasis and Sexually Transmitted Infections | ||||
| 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. |
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| 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:
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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label |
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| Condition ICMJE |
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| Intervention ICMJE | 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 |
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| Study Arm (s) | Experimental: STI/PZQ 1
Baseline and post-treatment follow-up (anti-STI and praziquantel Rx)
Intervention: Drug: Treatment with anti-STI and anti-schistosoma regimens |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 680 | ||||
| Completion Date | September 2003 | ||||
| Primary Completion Date | April 2002 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 15 Years to 49 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Madagascar | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00713999 | ||||
| Other Study ID Numbers ICMJE | IPM/DBL 01, RFU 1008600437 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Peter Derek Christian Leutscher, MD,PhD, Danish Bilharziasis Laboratory | ||||
| Study Sponsor ICMJE | University of Aarhus | ||||
| Collaborators ICMJE | Statens Serum Institut | ||||
| Investigators ICMJE |
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| Information Provided By | University of Aarhus | ||||
| Verification Date | July 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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