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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

July 8, 2008
July 11, 2008
August 2001
April 2002   (final data collection date for primary outcome measure)
Measurement of urogenital schistosomiasis and STI prevalence [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00713999 on ClinicalTrials.gov Archive Site
Urogenital and STI associated morbidity [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Urogenital Schistosomiasis and Sexually Transmitted Infections in Madagascar
Study of Reproductive Health in Rural Madagascar With Emphasis on Urogenital Schistosomiasis and Sexually Transmitted Infections

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
  • Sexually Transmitted Infections
  • Schistosoma Haematobium
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
Experimental: STI/PZQ 1
Baseline and post-treatment follow-up (anti-STI and praziquantel Rx)
Intervention: Drug: Treatment with anti-STI and anti-schistosoma regimens
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
680
September 2003
April 2002   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • children
  • negative Schistosoma haematobium egg excretion in urine
Both
15 Years to 49 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Madagascar
 
NCT00713999
IPM/DBL 01, RFU 1008600437
Yes
Peter Derek Christian Leutscher, MD,PhD, Danish Bilharziasis Laboratory
University of Aarhus
Statens Serum Institut
Principal Investigator: Peter DC Leutscher, MD, PhD Danish Bilharziasis Laboratory
University of Aarhus
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP