Urinary SchistosomiasisPhase 2NCT01132248
Activity of Mefloquine Against Urinary Schistosomiasis
A Phase 2 study testing Mefloquine and S/P in people with Urinary Schistosomiasis, run by Albert Schweitzer Hospital at 2 sites in Gabon.
Trial summary
Urinary schistosomiasis is a debilitating disease in Central Africa and pregnant women are frequently suffering from this condition. Mefloquine is currently investigated as preventive treatment against malaria in pregnancy and mefloquine is also known to exert activity against schistosomiasis. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Urinary Schistosomiasis
- What is being tested?
- Mefloquine and S/P
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 2 sitesGabon
- Study dates
- May 2010to Dec 2012
- Phase
- Phase 2
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant women after first trimester and before 28th week of pregnancy
- HIV negative
- Egg excretion of Schistosoma haematobium (mean >10 eggs per mL urine)
- Asymptomatic (no signs of complicated Schistosomiasis, no severe anemia)
- Ability to comply with study protocol
Who cannot join
- Intake of anthelminthic or antimalarial drug within 2 months prior to inclusion
- Allergy to study drugs
Trial locations and contacts
2 sites in 1 country.
Gabon2 sites
Albert Schweitzer Hospital
Lambaréné, Moyen-Ogooué Province, BP 115
Albert Schweitzer Hospital
Lambaréné
About this study
Urinary schistosomiasis is a debilitating disease in Central Africa and pregnant women are frequently suffering from this condition. Mefloquine is currently investigated as preventive treatment against malaria in pregnancy and mefloquine is also known to exert activity against schistosomiasis. The investigators want to test the hypothesis whether mefloquine may active against urinary schistosomiasis when used as preventive treatment against malaria in pregnancy.
Read the detailed description
Objectives
The principal aim of this clinical trial is to evaluate whether mefloquine - when given as intermittent preventive treatment against malaria in pregnancy - shows in vivo activity against concomitant Schistosoma haematobium infection. This study is therefore a "proof of principle" study and is not intended to establish a clinically satisfying cure rate or to formally compare the efficacy of mefloquine with the standard therapy.
Hypothesis
Two underlying hypotheses have been formulated for this proof of principle study.
Primary hypothesis: Mefloquine reduces egg excretion of Schistosoma haematobium by 50% compared to sulfadoxine/pyrimethamine (S/P) treatment when given as IPTp Secondary hypothesis: Mefloquine may lead to an adequate cure rates of Schistosoma haematobium infections compared to S/P (>80%)
Trial Design
The evaluation of mefloquine activity against S. haematobium will be evaluated in the course of an open label multicenter randomized controlled trial assessing the efficacy, tolerability, and safety of mefloquine IPTp against malaria. This study is therefore a nested randomized controlled trial taking advantage of the randomization and treatment allocation procedures of the IPTp trial and assessing the additional efficacy outcome of reduction of S. haematobium egg excretion.
- Conditions
- Urinary Schistosomiasis
- Being tested
- Mefloquine, S/P
- Keywords
- schistosomiasis, schistosoma haematobium
- Medical subject headings
- Schistosomiasis haematobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MefloquineDrug
15mg/kg mefloquine per dose Women receive two doses: One after the first trimester of pregnancy and the second at least one month after the first dose
S/PDrug
sulfadoxine-pyrimethamine IPTp will be administered following current WHO recommendations
| Study group | Role | What they receive |
|---|---|---|
| Mefloquine | Experimental | 15mg/kg mefloquine per dose Women receive two doses: One after the first trimester of pregnancy and the second at least one month after the first dose Receives: Drug: Mefloquine |
| S/P | Placebo comparator | sulfadoxine-pyrimethamine IPTp will be administered following current WHO recommendations Receives: Drug: S/P |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of egg excretion
Mefloquine reduces egg excretion of Schistosoma haematobium by 50% compared to sulfadoxine/pyrimethamine (S/P) treatment when given as IPTp
Measured: 6 weeks after second IPTp
Secondary outcomes (1)
Cure rate
Mefloquine may lead to an adequate cure rates of Schistosoma haematobium infections compared to S/P (>80%)
Measured: 6 weeks after first and second IPTp
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urinary SchistosomiasisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Schweitzer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Ramharter, Albert Schweitzer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01132248
- Sponsor's protocol ID
- IDC-2010-1
- Status last verified
- Jan 2013
- First submitted
- 27 May 2010
- Last updated
- 24 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Salam RA, Das JK, Bhutta ZA. Effect of mass deworming with antihelminthics for soil-transmitted helminths during pregnancy. Cochrane Database Syst Rev. 2021 May 17;5(5):CD005547. doi: 10.1002/14651858.CD005547.pub4.
PubMed 33998661Basra A, Mombo-Ngoma G, Melser MC, Diop DA, Wurbel H, Mackanga JR, Furstenau M, Zoleko RM, Adegnika AA, Gonzalez R, Menendez C, Kremsner PG, Ramharter M. Efficacy of mefloquine intermittent preventive treatment in pregnancy against Schistosoma haematobium infection in Gabon: a nested randomized controlled assessor-blinded clinical trial. Clin Infect Dis. 2013 Mar;56(6):e68-75. doi: 10.1093/cid/cis976. Epub 2012 Nov 21.
PubMed 23175561
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activity of Mefloquine Against Urinary Schistosomiasis
- ClinicalTrials.gov ID
- NCT01132248
- Acronym / sponsor ID
- IDC-2010-1
- Conditions
- Urinary Schistosomiasis
- Keywords
- schistosomiasis, schistosoma haematobium
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Albert Schweitzer HospitalUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 28 May 2010 (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.
Urinary schistosomiasis is a debilitating disease in Central Africa and pregnant women are frequently suffering from this condition. Mefloquine is currently investigated as preventive treatment against malaria in pregnancy and mefloquine is also known to exert activity against schistosomiasis. The investigators want to test the hypothesis whether mefloquine may active against urinary schistosomiasis when used as preventive treatment against malaria in pregnancy.
Detailed description
Objectives
The principal aim of this clinical trial is to evaluate whether mefloquine - when given as intermittent preventive treatment against malaria in pregnancy - shows in vivo activity against concomitant Schistosoma haematobium infection. This study is therefore a "proof of principle" study and is not intended to establish a clinically satisfying cure rate or to formally compare the efficacy of mefloquine with the standard therapy.
Hypothesis
Two underlying hypotheses have been formulated for this proof of principle study.
Primary hypothesis: Mefloquine reduces egg excretion of Schistosoma haematobium by 50% compared to sulfadoxine/pyrimethamine (S/P) treatment when given as IPTp Secondary hypothesis: Mefloquine may lead to an adequate cure rates of Schistosoma haematobium infections compared to S/P (>80%)
Trial Design
The evaluation of mefloquine activity against S. haematobium will be evaluated in the course of an open label multicenter randomized controlled trial assessing the efficacy, tolerability, and safety of mefloquine IPTp against malaria. This study is therefore a nested randomized controlled trial taking advantage of the randomization and treatment allocation procedures of the IPTp trial and assessing the additional efficacy outcome of reduction of S. haematobium egg excretion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mefloquine | Experimental | Drug: Mefloquine15mg/kg mefloquine per dose Women receive two doses: One after the first trimester of pregnancy and the second at least one month after the first dose |
| S/P | Placebo comparator | Drug: S/Psulfadoxine-pyrimethamine IPTp will be administered following current WHO recommendations |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Pregnant women after first trimester and before 28th week of pregnancy
- HIV negative
- Egg excretion of Schistosoma haematobium (mean >10 eggs per mL urine)
- Asymptomatic (no signs of complicated Schistosomiasis, no severe anemia)
- Ability to comply with study protocol
Key exclusion criteria (2 listed)
- Intake of anthelminthic or antimalarial drug within 2 months prior to inclusion
- Allergy to study drugs
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 |
|---|---|---|
| Mefloquine15mg/kg mefloquine per dose Women receive two doses: One after the first trimester of pregnancy and the second at least one month after the first dose | Drug | Mefloquine |
| S/Psulfadoxine-pyrimethamine IPTp will be administered following current WHO recommendations | Drug | S/P |
Primary outcome
Reduction of egg excretion
Time frame: 6 weeks after second IPTp
Mefloquine reduces egg excretion of Schistosoma haematobium by 50% compared to sulfadoxine/pyrimethamine (S/P) treatment when given as IPTp
1 secondary outcome
Cure rate
Time frame: 6 weeks after first and second IPTp
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 24 Jan 2013.
- Derived from this study: PubMed 33998661Salam RA, Das JK, Bhutta ZA. Effect of mass deworming with antihelminthics for soil-transmitted helminths during pregnancy. Cochrane Database Syst Rev. 2021 May 17;5(5):CD005547. doi: 10.1002/14651858.CD005547.pub4.
- Derived from this study: PubMed 23175561Basra A, Mombo-Ngoma G, Melser MC, Diop DA, Wurbel H, Mackanga JR, Furstenau M, Zoleko RM, Adegnika AA, Gonzalez R, Menendez C, Kremsner PG, Ramharter M. Efficacy of mefloquine intermittent preventive treatment in pregnancy against Schistosoma haematobium infection in Gabon: a nested randomized controlled assessor-blinded clinical trial. Clin Infect Dis. 2013 Mar;56(6):e68-75. doi: 10.1093/cid/cis976. Epub 2012 Nov 21.
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Schistosoma Haematobium
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mefloquine and S/P in people with Urinary Schistosomiasis, run by Albert Schweitzer Hospital at 2 sites in Gabon.
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 5 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 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Gabon. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Reduction of egg excretion (time frame: 6 weeks after second IPTp). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01132248, which also lists 2 linked publications.
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 24 Jan 2013.