Urogenital Schistosomiasis and Sexually Transmitted Infections in Madagascar

Sexually Transmitted Infections Clinical Trial

— FGS/MGS/STI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00713999
• Other study ID #: IPM/DBL 01
• Secondary ID: RFU 1008600437
• Status: Completed
• Phase: N/A
• First received: July 8, 2008
• Last updated: July 11, 2008
• Start date: August 2001
• Est. completion date: September 2003

Study information

• Verified date: July 2008
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Madagascar: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 680
• Est. completion date: September 2003
• Est. primary completion date: April 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 49 Years

Eligibility

Inclusion Criteria:

• adults

• positive Schistosoma haematobium egg excretion in urine

• signed written consensus

Exclusion Criteria:

• children

• negative Schistosoma haematobium egg excretion in urine

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Schistosoma Haematobium
• Schistosomiasis
• Schistosomiasis haematobia
• Sexually Transmitted Diseases
• Sexually Transmitted Infections

Intervention

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

Locations

Country	Name	City	State
Madagascar	Institut Pasteur	Antananarivo

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Statens Serum Institut

Country where clinical trial is conducted

Madagascar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of urogenital schistosomiasis and STI prevalence		2 months	No
Secondary	Urogenital and STI associated morbidity		2 months	No