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NCT Number: NCT00713999

Urogenital Schistosomiasis and Sexually Transmitted Infections in Madagascar

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • children
  • negative Schistosoma haematobium egg excretion in urine

Treatment and study plan

Treatment with anti-STI and anti-schistosoma regimens

Drug

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 names: Biltricide

Primary outcomes

  1. Measurement of urogenital schistosomiasis and STI prevalence

    Time frame: 2 months

Secondary outcomes

  1. Urogenital and STI associated morbidity

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Statens Serum Institut

Registry information

Official study title

Study of Reproductive Health in Rural Madagascar With Emphasis on Urogenital Schistosomiasis and Sexually Transmitted Infections

Acronym: FGS/MGS/STI

Important dates

Study start
2001
Primary completion
2002
Study completion
2003
First posted
Jul 14, 2008
Registry last updated
Jul 14, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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