Schistosoma MansoniPhase 3NCT01054651
A Randomised Trial of Artesunate-sulfamethoxypyrazine/Pyrimethamine Versus Praziquantel for the Treatment of S. Mansoni
A Phase 3 study testing Artesunate+Sulfamethoxypyrazine/pyrimethamine and Praziquantel in people with Schistosoma Mansoni, run by Kenya Medical Research Institute at 1 site in Kenya.
Trial summary
The purpose of this study is to determine the comparative efficacy of artesunate plus sulfamethoxypyrazine-pyrimethamine versus Praziquantel in the treatment of school children infected with S.mansoni in western Kenya. Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Schistosoma Mansoni
- What is being tested?
- Artesunate+Sulfamethoxypyrazine/pyrimethamine and Praziquantel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteKenya
- Study dates
- Oct 2009to Dec 2009
- Phase
- Phase 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged between 6 and 15 years old
- Study participants appear healthy at enrollment, as assessed by the study clinician
- Suffering from S. mansoni infection, excreting eggs in stool
- Residing in Uyoma area, near Lake Victoria
- Able to receive oral treatment
- Parent/legal guardian gives informed written consent for the child to participate in the study
- Child assent to participate in study
Who cannot join
- Weighing more than 50 kg
- Pregnant or lactating at the time of the study
- Presence of infection with Plasmodium falciparum or other Plasmodium spp.
- Presence of severe illness, such as cerebral cysticercosis
- Signs of severe malnutrition (defined as children with weight/height ratio below 3 standard deviations or below 70% of the median of the WHO standardized reference values, or still with symmetrical oedema affecting both feet)
- Hypersensitivity to As, sulfonamides or PZQ.
- Use of another anti-malaria or anti-schistosomal drug during the study, or within 28 days before the administration of treatment.
- Previous participation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Randomized Clinical Trial in Kenya to Determine the Effectiveness of Artesunate + Sulfamethoxypyrazine/Pyrimethamine Vs. Praziquantel in the Treatment of S. Mansoni in Children
The purpose of this study is to determine the comparative efficacy of artesunate plus sulfamethoxypyrazine-pyrimethamine versus Praziquantel in the treatment of school children infected with S.mansoni in western Kenya.
Read the detailed description
Schistosomiasis remains an important parasitic disease in the tropics, including Kenya. In the absence of a vaccine, the major control strategy is the reduction of morbidity by chemotherapy using Praziquantel. Evidence from laboratory studies and field trials continue to show that schistosome worms have developed reduced susceptibility to Praziquantel. These observations indicate the need for research to monitor the trends in efficacy of praziquantel and the need for research to develop novel antischistosomal drugs. Randomized controlled trials have also shown that Artemisinin derivatives (artesunate, artemether) have antischistosomal activity against S. mansoni, S. haematobium and S. japonicum. We propose to conduct an open-label, randomized trial to evaluate the comparative efficacy of artesunate plus sulfamethoxypyrazine-pyrimethamine versus Praziquantel in the treatment of 212 school children infected with S.mansoni in Rarieda district in western Kenya. To do this we will screen about 1000 school children by examination of stool for schistosome eggs. Eligible children will be randomized to receive either artesunate plus sulfamethoxypyrazine-pyrimethamine over 3 days or a single dose of Praziquantel. Four weeks after treatment, the participants will be assessed for cure and egg reduction.Our study may provide vital information regarding an alternative treatment for S. mansoni infection in children.
- Conditions
- Schistosoma Mansoni
- Being tested
- Artesunate+Sulfamethoxypyrazine/pyrimethamine, Praziquantel
- Keywords
- Schistosoma mansoni, Praziquantel, Artesunate + Sulfamethoxypyrazine/pyrimethamine, Randomized open-label controlled clinical trial
- Medical subject headings
- Schistosomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artesunate+Sulfamethoxypyrazine/pyrimethamineDrug
Also called Co-arinate FDC
PraziquantelDrug
Also called Biltricide
| Study group | Role | What they receive |
|---|---|---|
| Artesunate+Sulfamethoxypyrazine/pyrimethamine | Experimental | Not described Receives: Drug: Artesunate+Sulfamethoxypyrazine/pyrimethamine |
| Praziquantel | Active comparator | Not described Receives: Drug: Praziquantel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the cure rate between the two treatment arms
Measured: after 28 days
Secondary outcomes (3)
Compare the proportion of children excreting schistosoma eggs between the two treatment arms
Measured: after 28 days
Compare the amount of eggs produced between the two arms
Measured: after 28 days
Compare the incidence of clinical and biological adverse events
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 posted22 Jan 2010 (estimated)
- Study startOct 2009
- Primary completionDec 2009
- Study completionDec 2009
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 MansoniStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kenya Medical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Dafra Pharma
- Investigators
- Pauline N Mwinzi, PhD, Study director, Kenya Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01054651
- Sponsor's protocol ID
- KEMRI SSC 1582
- Other IDs
- DRD140 - S6.2008
- Status last verified
- Jan 2010
- First submitted
- 21 Jan 2010
- Last updated
- 22 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Obonyo CO, Muok EM, Mwinzi PN. Efficacy of artesunate with sulfalene plus pyrimethamine versus praziquantel for treatment of Schistosoma mansoni in Kenyan children: an open-label randomised controlled trial. Lancet Infect Dis. 2010 Sep;10(9):603-11. doi: 10.1016/S1473-3099(10)70161-4. Epub 2010 Aug 10.
PubMed 20705516
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Randomized Clinical Trial in Kenya to Determine the Effectiveness of Artesunate + Sulfamethoxypyrazine/Pyrimethamine Vs. Praziquantel in the Treatment of S. Mansoni in Children
- ClinicalTrials.gov ID
- NCT01054651
- Acronym / sponsor ID
- KEMRI SSC 1582
- Conditions
- Schistosoma Mansoni
- Keywords
- Schistosoma mansoni, Praziquantel, Artesunate + Sulfamethoxypyrazine/pyrimethamine, Randomized open-label controlled clinical trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Kenya Medical Research InstituteUniversity, hospital or other
- Collaborators
- Dafra Pharma
- Study start
- Oct 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 22 Jan 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.
The purpose of this study is to determine the comparative efficacy of artesunate plus sulfamethoxypyrazine-pyrimethamine versus Praziquantel in the treatment of school children infected with S.mansoni in western Kenya.
Detailed description
Schistosomiasis remains an important parasitic disease in the tropics, including Kenya. In the absence of a vaccine, the major control strategy is the reduction of morbidity by chemotherapy using Praziquantel. Evidence from laboratory studies and field trials continue to show that schistosome worms have developed reduced susceptibility to Praziquantel. These observations indicate the need for research to monitor the trends in efficacy of praziquantel and the need for research to develop novel antischistosomal drugs. Randomized controlled trials have also shown that Artemisinin derivatives (artesunate, artemether) have antischistosomal activity against S. mansoni, S. haematobium and S. japonicum. We propose to conduct an open-label, randomized trial to evaluate the comparative efficacy of artesunate plus sulfamethoxypyrazine-pyrimethamine versus Praziquantel in the treatment of 212 school children infected with S.mansoni in Rarieda district in western Kenya. To do this we will screen about 1000 school children by examination of stool for schistosome eggs. Eligible children will be randomized to receive either artesunate plus sulfamethoxypyrazine-pyrimethamine over 3 days or a single dose of Praziquantel. Four weeks after treatment, the participants will be assessed for cure and egg reduction.Our study may provide vital information regarding an alternative treatment for S. mansoni infection in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Artesunate+Sulfamethoxypyrazine/pyrimethamine | Experimental | Drug: Artesunate+Sulfamethoxypyrazine/pyrimethamine |
| Praziquantel | Active comparator | Drug: Praziquantel |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Aged between 6 and 15 years old
- Study participants appear healthy at enrollment, as assessed by the study clinician
- Suffering from S. mansoni infection, excreting eggs in stool
- Residing in Uyoma area, near Lake Victoria
- Able to receive oral treatment
Key exclusion criteria (8 listed)
- Weighing more than 50 kg
- Pregnant or lactating at the time of the study
- Presence of infection with Plasmodium falciparum or other Plasmodium spp.
- Presence of severe illness, such as cerebral cysticercosis
- Signs of severe malnutrition (defined as children with weight/height ratio below 3 standard deviations or below 70% of the median of the WHO standardized reference values, or still with symmetrical oedema affecting both feet)
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/pyrimethamineAlso: Co-arinate FDC | Drug | Artesunate+Sulfamethoxypyrazine/pyrimethamine |
| PraziquantelAlso: Biltricide | Drug | Praziquantel |
Primary outcome
Compare the cure rate between the two treatment arms
Time frame: after 28 days
3 secondary outcomes
Compare the proportion of children excreting schistosoma eggs between the two treatment arms
Time frame: after 28 days
Compare the amount of eggs produced between the two arms
Time frame: after 28 days
Compare the incidence of clinical and biological adverse events
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 22 Jan 2010.
- Derived from this study: PubMed 20705516Obonyo CO, Muok EM, Mwinzi PN. Efficacy of artesunate with sulfalene plus pyrimethamine versus praziquantel for treatment of Schistosoma mansoni in Kenyan children: an open-label randomised controlled trial. Lancet Infect Dis. 2010 Sep;10(9):603-11. doi: 10.1016/S1473-3099(10)70161-4. Epub 2010 Aug 10.
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Schistosomiasis, Schistosoma Mansoni
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.
Pauline N Mwinzi, PhD study director
Kenya Medical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Artesunate+Sulfamethoxypyrazine/pyrimethamine and Praziquantel in people with Schistosoma Mansoni, run by Kenya Medical Research Institute at 1 site in Kenya.
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 7 inclusion and 8 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 22 Jan 2010. 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 Kenya. 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 phase mean?
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 cure rate between the two treatment arms (time frame: after 28 days). 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 NCT01054651, 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 22 Jan 2010.