NCT00713999

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
680

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2001

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2002

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 14, 2008

Completed
Last Updated

July 14, 2008

Status Verified

July 1, 2008

Enrollment Period

8 months

First QC Date

July 8, 2008

Last Update Submit

July 11, 2008

Conditions

Sexually Transmitted InfectionsSchistosoma Haematobium

Keywords

Sexually transmitted infectionsUrogenital schistosomiasisSchistosoma haematobiumReproductive healthPelvic examinationUltrasonographyQuestionnaireMadagascar

Outcome Measures

Primary Outcomes (1)

  • Measurement of urogenital schistosomiasis and STI prevalence

    2 months

Secondary Outcomes (1)

  • Urogenital and STI associated morbidity

    2 months

Study Arms (1)

STI/PZQ 1

EXPERIMENTAL

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

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

Interventions

Treatment with anti-STI and anti-schistosoma regimensDRUG

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
STI/PZQ 1

Eligibility Criteria

Age15 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • children
  • negative Schistosoma haematobium egg excretion in urine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Pasteur

Antananarivo, 100, Madagascar

Location

MeSH Terms

Conditions

Sexually Transmitted DiseasesSchistosomiasis haematobia

Interventions

TherapeuticsPraziquantel

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSchistosomiasisTrematode InfectionsHelminthiasisParasitic DiseasesUrinary Tract InfectionsVector Borne DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

IsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Peter DC Leutscher, MD, PhD

    Danish Bilharziasis Laboratory

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 8, 2008

First Posted

July 14, 2008

Study Start

August 1, 2001

Primary Completion

April 1, 2002

Study Completion

September 1, 2003

Last Updated

July 14, 2008

Record last verified: 2008-07

Locations

MA(1)