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Urogenital Schistosomiasis and Sexually Transmitted Infections in Madagascar

NCT ID: NCT00713999

Last Updated: 2008-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

680 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-08-31

Study Completion Date

2003-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sexually Transmitted Infections Schistosoma Haematobium

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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STI/PZQ 1

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

Group Type EXPERIMENTAL

Treatment with anti-STI and anti-schistosoma regimens

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Biltricide

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* children
* negative Schistosoma haematobium egg excretion in urine
Minimum Eligible Age

15 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Statens Serum Institut

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Danish Bilharziasis Laboratory

Principal Investigators

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Peter DC Leutscher, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Danish Bilharziasis Laboratory

Locations

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Institut Pasteur

Antananarivo, , Madagascar

Site Status

Countries

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Madagascar

Other Identifiers

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RFU 1008600437

Identifier Type: -

Identifier Source: secondary_id

IPM/DBL 01

Identifier Type: -

Identifier Source: org_study_id