Schistosoma HaematobiumPhase 2/3NCT00510159
Comparing Praziquantel Versus Artesunate + Sulfamethoxypyrazine/Pyrimethamine for Treating Schistosomiasis
A Phase 2/3 study testing Artesunate+Sulfamethoxypyrazine/pyrimethamin and Praziquantel in people with Schistosoma Haematobium, run by Dafra Pharma at 1 site in Mali.
Trial summary
The purpose of this study is to evaluate the efficacy of praziquantel versus As+SMP (Co-Arinate FDC ®) in the treatment of Schistosoma haematobium in 6-15 year old Malian children. The nul-hypothesis in this study is that the combination of As+SMP is more effective than praziquantel in the treatment of S. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Schistosoma Haematobium
- What is being tested?
- Artesunate+Sulfamethoxypyrazine/pyrimethamin and Praziquantel
- How many people
- 800 participants
- Where
- 1 siteMali
- Study dates
- Aug 2007to Dec 2007
- Phase
- Phase 2/3
- 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 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged between 6-15 years
- In good health, according to study doctor
- Suffering from urinary schistosomiasis, as diagnosed by the presence of S. haematobium eggs in the urine.
- Residents of Djalakorodji
- Capable of taking oral medication
- Written informed consent to participate in the study, obtained from parent or legal guardian.
Who cannot join
- Weighing more than 50 kg
- Being pregnant or lactating at the time of the study
- Patient has a severe concomitant disease, as determined by the clinical examination, such as cerebral cysticercosis, HIV,...
- Signs of severe malnutrition (children weighing/measuring more than 3 standard deviations or less than 70% of the median standard reference values determined by WHO, or with systemic oedema affecting both feet).
- Hypersensitivity to As, SMP or PZQ
- Having taken other antimalarial or antischistosomal medication during the study.
- Having participated in previous similar studies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Double Blind Clinical Trial in Mali, Comparing the Effectiveness of Artesunate + Sulfamethoxypyrazine/Pyrimethamine Versus Praziquantel in the Treatment of S. Haematobium in Children
The purpose of this study is to evaluate the efficacy of praziquantel versus As+SMP (Co-Arinate FDC ®) in the treatment of Schistosoma haematobium in 6-15 year old Malian children. The nul-hypothesis in this study is that the combination of As+SMP is more effective than praziquantel in the treatment of S. haematobium infected children.
- Conditions
- Schistosoma Haematobium
- Being tested
- Artesunate+Sulfamethoxypyrazine/pyrimethamin, Praziquantel
- Keywords
- Schistosoma haematobium, Praziquantel, Artesunate + Sulfamethoxypyrazine/pyrimethamine, Randomized double blind placebo controlled clinical trial
- Medical subject headings
- Schistosomiasis haematobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artesunate+Sulfamethoxypyrazine/pyrimethaminDrug
Also called Co-Arinate FDC ®
PraziquantelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the parasite load between the two treatment arms
Measured: After 28 days
Compare the amount of eggs produced between the two treatment arms
Measured: After 28 days
Compare cure rate between the two treatment arms
Measured: After 28 days
Secondary outcomes (2)
Evaluate changes in urine appearance before and after treatment
Measured: After 28 days
Evaluate changes in haematuria frequency before and after treatment
Measured: After 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionOct 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Schistosoma HaematobiumStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dafra Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mahamadou S Sissoko, MD, MSPH, Principal investigator, University of Bamako, Mali
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00510159
- Sponsor's protocol ID
- 2007/S4
- Status last verified
- Jul 2007
- First submitted
- 31 Jul 2007
- Last updated
- 18 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Sissoko MS, Dabo A, Traore H, Diallo M, Traore B, Konate D, Niare B, Diakite M, Kamate B, Traore A, Bathily A, Tapily A, Toure OB, Cauwenbergh S, Jansen HF, Doumbo OK. Efficacy of artesunate + sulfamethoxypyrazine/pyrimethamine versus praziquantel in the treatment of Schistosoma haematobium in children. PLoS One. 2009 Oct 5;4(10):e6732. doi: 10.1371/journal.pone.0006732.
PubMed 19802383
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blind Clinical Trial in Mali, Comparing the Effectiveness of Artesunate + Sulfamethoxypyrazine/Pyrimethamine Versus Praziquantel in the Treatment of S. Haematobium in Children
- ClinicalTrials.gov ID
- NCT00510159
- Acronym / sponsor ID
- 2007/S4
- Conditions
- Schistosoma Haematobium
- Keywords
- Schistosoma haematobium, Praziquantel, Artesunate + Sulfamethoxypyrazine/pyrimethamine, Randomized double blind placebo controlled clinical trial
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Dafra PharmaIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 1 Aug 2007 (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.
The purpose of this study is to evaluate the efficacy of praziquantel versus As+SMP (Co-Arinate FDC ®) in the treatment of Schistosoma haematobium in 6-15 year old Malian children. The nul-hypothesis in this study is that the combination of As+SMP is more effective than praziquantel in the treatment of S. haematobium infected children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Aged between 6-15 years
- In good health, according to study doctor
- Suffering from urinary schistosomiasis, as diagnosed by the presence of S. haematobium eggs in the urine.
- Residents of Djalakorodji
- Capable of taking oral medication
Key exclusion criteria (7 listed)
- Weighing more than 50 kg
- Being pregnant or lactating at the time of the study
- Patient has a severe concomitant disease, as determined by the clinical examination, such as cerebral cysticercosis, HIV,...
- Signs of severe malnutrition (children weighing/measuring more than 3 standard deviations or less than 70% of the median standard reference values determined by WHO, or with systemic oedema affecting both feet).
- Hypersensitivity to As, SMP or PZQ
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 |
|---|---|---|
| Artesunate+Sulfamethoxypyrazine/pyrimethaminAlso: Co-Arinate FDC ® | Drug | – |
| Praziquantel | Drug | – |
Primary outcome
Compare the parasite load between the two treatment arms
Time frame: After 28 days
Compare the amount of eggs produced between the two treatment arms
Time frame: After 28 days
Compare cure rate between the two treatment arms
Time frame: After 28 days
2 secondary outcomes
Evaluate changes in urine appearance before and after treatment
Time frame: After 28 days
Evaluate changes in haematuria frequency before and after treatment
Time frame: After 28 days
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 18 Jan 2008.
- Derived from this study: PubMed 19802383Sissoko MS, Dabo A, Traore H, Diallo M, Traore B, Konate D, Niare B, Diakite M, Kamate B, Traore A, Bathily A, Tapily A, Toure OB, Cauwenbergh S, Jansen HF, Doumbo OK. Efficacy of artesunate + sulfamethoxypyrazine/pyrimethamine versus praziquantel in the treatment of Schistosoma haematobium in children. PLoS One. 2009 Oct 5;4(10):e6732. doi: 10.1371/journal.pone.0006732.
Related trials for Schistosoma Haematobium
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Possible Diagnostic Protein Markers in Schistosoma Related Bladder Diseases.
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.
Mahamadou S Sissoko, MD, MSPH principal investigator
University of Bamako, Mali
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Artesunate+Sulfamethoxypyrazine/pyrimethamin and Praziquantel in people with Schistosoma Haematobium, run by Dafra Pharma at 1 site in Mali.
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 6 inclusion and 7 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 18 Jan 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 Mali. 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.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Compare the parasite load between the two treatment arms (time frame: After 28 days). The study lists 3 primary outcomes in all. 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 NCT00510159, which also lists 1 linked publication.
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 18 Jan 2008.