Sexually Transmitted InfectionsFGS/MGS/STINCT00713999
Urogenital Schistosomiasis and Sexually Transmitted Infections in Madagascar
A study testing Treatment with anti-STI and anti-schistosoma regimens in people with Sexually Transmitted Infections and Schistosoma Haematobium, run by University of Aarhus at 1 site in Madagascar.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Infections, Schistosoma Haematobium
- What is being tested?
- Treatment with anti-STI and anti-schistosoma regimens
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 680 participants
- Where
- 1 siteMadagascar
- Study dates
- Aug 2001to Sep 2003
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- adults
- positive Schistosoma haematobium egg excretion in urine
- signed written consensus
Who cannot join
- children
- negative Schistosoma haematobium egg excretion in urine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Being tested
- Treatment with anti-STI and anti-schistosoma regimens
- Keywords
- Sexually transmitted infections, Urogenital schistosomiasis, Schistosoma haematobium, Reproductive health, Pelvic examination, Ultrasonography, Questionnaire, Madagascar
- Medical subject headings
- Sexually Transmitted Diseases, Schistosomiasis haematobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with anti-STI and anti-schistosoma regimensDrug
Also called Biltricide
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
| Study group | Role | What they receive |
|---|---|---|
| STI/PZQ 1 | Experimental | Baseline and post-treatment follow-up (anti-STI and praziquantel Rx) Receives: Drug: Treatment with anti-STI and anti-schistosoma regimens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of urogenital schistosomiasis and STI prevalence
Measured: 2 months
Secondary outcomes (1)
Urogenital and STI associated morbidity
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startAug 2001
- Primary completionApr 2002
- Study completionSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexually Transmitted InfectionsStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 680 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Statens Serum Institut
- Investigators
- Peter DC Leutscher, MD, PhD, Principal investigator, Danish Bilharziasis Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00713999
- Sponsor's protocol ID
- IPM/DBL 01
- Other IDs
- RFU 1008600437
- Acronym
- FGS/MGS/STI
- Status last verified
- Jul 2008
- First submitted
- 8 Jul 2008
- Last updated
- 14 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Reproductive Health in Rural Madagascar With Emphasis on Urogenital Schistosomiasis and Sexually Transmitted Infections
- ClinicalTrials.gov ID
- NCT00713999
- Acronym / sponsor ID
- FGS/MGS/STI / IPM/DBL 01
- Keywords
- Sexually transmitted infections, Urogenital schistosomiasis, Schistosoma haematobium, Reproductive health, Pelvic examination, Ultrasonography, Questionnaire, Madagascar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 680 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Statens Serum Institut
- Study start
- Aug 2001
- Primary completion
- Apr 2002 (actual)
- Study completion
- Sep 2003 (actual)
- First posted
- 14 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STI/PZQ 1 | Experimental | Drug: Treatment with anti-STI and anti-schistosoma regimensBaseline and post-treatment follow-up (anti-STI and praziquantel Rx) |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- adults
- positive Schistosoma haematobium egg excretion in urine
- signed written consensus
Key exclusion criteria (2 listed)
- children
- negative Schistosoma haematobium egg excretion in urine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment with anti-STI and anti-schistosoma regimensAlso: BiltricideAnti-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 | Drug | STI/PZQ 1 |
Primary outcome
Measurement of urogenital schistosomiasis and STI prevalence
Time frame: 2 months
1 secondary outcome
Urogenital and STI associated morbidity
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2008.
Related trials for Sexually Transmitted Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Enrolling by invitation
Promoting Aging and Thriving With HIV
HIV (Human Immunodeficiency Virus), Geriatric
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter DC Leutscher, MD, PhD principal investigator
Danish Bilharziasis Laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with anti-STI and anti-schistosoma regimens in people with Sexually Transmitted Infections and Schistosoma Haematobium, run by University of Aarhus at 1 site in Madagascar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Madagascar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of urogenital schistosomiasis and STI prevalence (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2008.