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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00713999
Recruitment Status : Completed
First Posted : July 14, 2008
Last Update Posted : July 14, 2008
Statens Serum Institut
Information provided by:
University of Aarhus

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.

Condition or disease Intervention/treatment Phase
Sexually Transmitted Infections Schistosoma Haematobium Drug: Treatment with anti-STI and anti-schistosoma regimens Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 680 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Study of Reproductive Health in Rural Madagascar With Emphasis on Urogenital Schistosomiasis and Sexually Transmitted Infections
Study Start Date : August 2001
Actual Primary Completion Date : April 2002
Actual Study Completion Date : September 2003

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Measurement of urogenital schistosomiasis and STI prevalence [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Urogenital and STI associated morbidity [ Time Frame: 2 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00713999

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

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Responsible Party: Peter Derek Christian Leutscher, MD,PhD, Danish Bilharziasis Laboratory Identifier: NCT00713999     History of Changes
Other Study ID Numbers: IPM/DBL 01
RFU 1008600437
First Posted: July 14, 2008    Key Record Dates
Last Update Posted: July 14, 2008
Last Verified: July 2008

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

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