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Urogenital Schistosomiasis and Sexually Transmitted Infections in Madagascar (FGS/MGS/STI)

This study has been completed.
Sponsor:
Collaborator:
Statens Serum Institut
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00713999
First received: July 8, 2008
Last updated: July 11, 2008
Last verified: July 2008
History of Changes
  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: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Study of Reproductive Health in Rural Madagascar With Emphasis on Urogenital Schistosomiasis and Sexually Transmitted Infections

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Measurement of urogenital schistosomiasis and STI prevalence [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Urogenital and STI associated morbidity [ Time Frame: 2 months ] [ Designated as safety issue: No ]

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
Experimental: STI/PZQ 1
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
Other Name: Biltricide

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.

  Eligibility

Ages Eligible for Study:   15 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • children
  • negative Schistosoma haematobium egg excretion in urine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00713999

Locations
Madagascar
Institut Pasteur
Antananarivo, Madagascar, 100
Sponsors and Collaborators
University of Aarhus
Statens Serum Institut
Investigators
Principal Investigator: Peter DC Leutscher, MD, PhD Danish Bilharziasis Laboratory
  More Information

No publications provided

Responsible Party: Peter Derek Christian Leutscher, MD,PhD, Danish Bilharziasis Laboratory
ClinicalTrials.gov Identifier: NCT00713999     History of Changes
Other Study ID Numbers: IPM/DBL 01, RFU 1008600437
Study First Received: July 8, 2008
Last Updated: July 11, 2008
Health Authority: Madagascar: Ministry of Health

Keywords provided by University of Aarhus:
Sexually transmitted infections
Urogenital schistosomiasis
Schistosoma haematobium
Reproductive health
 Pelvic examination
Ultrasonography
Questionnaire
Madagascar

Additional relevant MeSH terms:
Schistosomiasis haematobia
Schistosomiasis
Sexually Transmitted Diseases
Urinary Tract Infections
Infection
Trematode Infections
 Helminthiasis
Parasitic Diseases
Urologic Diseases
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 22, 2013