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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00713999
Acronym
FGS/MGS/STI
Enrollment
680
Registered
2008-07-14
Start date
2001-08-31
Completion date
2003-09-30
Last updated
2008-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schistosoma Haematobium, Sexually Transmitted Infections

Keywords

Sexually transmitted infections, Urogenital schistosomiasis, Schistosoma haematobium, Reproductive health, Pelvic examination, Ultrasonography, Questionnaire, Madagascar

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.

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.

Interventions

DRUGTreatment 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

Sponsors

Statens Serum Institut
CollaboratorOTHER
University of Aarhus
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 49 Years
Healthy volunteers
Yes

Inclusion criteria

* adults * positive Schistosoma haematobium egg excretion in urine * signed written consensus

Exclusion criteria

* children * negative Schistosoma haematobium egg excretion in urine

Design outcomes

Primary

MeasureTime frame
Measurement of urogenital schistosomiasis and STI prevalence2 months

Secondary

MeasureTime frame
Urogenital and STI associated morbidity2 months

Countries

Madagascar

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026