ClinicalTrials.gg
CompletedNCT00713999FGS/MGS/STIUpdated Jul 14, 2008

Urogenital Schistosomiasis and Sexually Transmitted Infections in Madagascar

An interventional study of Treatment with anti-STI and anti-schistosoma regimens in Sexually Transmitted Infections and Schistosoma Haematobium, sponsored by University of Aarhus. Completed at 1 site in Madagascar. Open to participants aged 15 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-07-14.

Sponsored by University of Aarhus · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
680
Allocation
Not applicable
Ages
15 Years to 49 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Sexually Transmitted Infections
  • Schistosoma Haematobium

Keywords

  • Sexually transmitted infections
  • Urogenital schistosomiasis
  • Schistosoma haematobium
  • Reproductive health
  • Pelvic examination
  • Ultrasonography
  • Questionnaire
  • Madagascar
03

In context

Sexually Transmitted Diseases

523 studies on the registry are indexed under Sexually Transmitted Diseases; 77 are open to participants now.

This study's enrollment of 680 is above the median of 449 across 425 interventional studies indexed under Sexually Transmitted Diseases.

Browse Sexually Transmitted Diseases studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 49 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • children
  • negative Schistosoma haematobium egg excretion in urine
05

Study design

Phase
Not applicable
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
680 participants (actual)

Study arms

  • Experimental
    STI/PZQ 1

    Baseline and post-treatment follow-up (anti-STI and praziquantel Rx)

    Drug: Treatment with anti-STI and anti-schistosoma regimens

Interventions

  • DrugTreatment with anti-STI and anti-schistosoma regimens

    Drug page: Praziquantel

    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

    Also known as: Biltricide

06

What researchers measure

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

07

Study locations

1 site
  • Institut Pasteur
    Antananarivo, 100, Madagascar
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2001, a primary completion of Apr 2002 and a completion of Sep 2003. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 8, 2008
First posted
Jul 14, 2008
Start
Aug 2001
Primary completionActual
Apr 2002
CompletionActual
Sep 2003
Last update
Jul 14, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 14, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00713999
Collaborators
Statens Serum Institut
First posted
Jul 14, 2008
Start date
Aug 2001
Primary completion
Apr 2002
Completion
Sep 2003
Last update
Jul 14, 2008

Study contacts

Peter DC Leutscher, MD, PhD
principal investigator · Danish Bilharziasis Laboratory

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Praziquantel

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