Uncomplicated MalariaNCT00460369
Treatment of Uncomplicated Malaria in Benin
A study testing sulfadoxine-pyrimethamine, artemether-lumefantrine and amodiaquine-artesunate coformulation in people with Uncomplicated Malaria, run by Institut de Recherche pour le Developpement at 1 site in Benin.
Trial summary
Malaria is a life-threatening disease especially in small children. A high degree of Plasmodium falciparum resistance to chloroquine has already spread to South-Benin where this study is taking place. Read more about this study
- Who is it for?
- Ages 6 to 119 months
- Conditions the study is for
- Uncomplicated Malaria
- What is being tested?
- sulfadoxine-pyrimethamine, artemether-lumefantrine and amodiaquine-artesunate coformulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteBenin
- Study dates
- Apr 2007to Nov 2007
- 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 6 to 119 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 6-119 months old
- fever or history of fever of less than 24 hours
- p falciparum parasitemia > 1000 trophozoïtes/µL
- informed consent signed
Who cannot join
- < 5 kg
- danger or severity signs of malaria
- known underlying chronic disease
- Hb < 5g/dL
- adequate malaria treatment taken within 3 days before visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sulfadoxine-Pyrimethamine Versus Artemether-Lumefantrine Versus Amodiaquine-Artesunate Coformulation in Uncomplicated Plasmodium Falciparum Malaria : an Open Randomized Study
Malaria is a life-threatening disease especially in small children. A high degree of Plasmodium falciparum resistance to chloroquine has already spread to South-Benin where this study is taking place. In the past few years, the recommendation for a first-line treatment in this area has moved from chloroquine to sulfadoxine-pyrimethamine (SP). There is growing evidence that Plasmodium falciparum resistance to SP has come to South-Benin. The aim of the study is to compare the efficacy of SP to two compact artemisinin-based therapies (ACT): artemether-lumefantrine and the amodiaquine-artesunate coformulation. ACT will be unsupervised.
The primary endpoint is an effectiveness comparison (PCR corrected) at day 28. Secondary outcomes are effectiveness comparisons (PCR corrected) at day 14 and 42 and a study on the relationships between ACT PK data (day 3) and outcome.
Read more
Expected total enrollment: 225 patients
Study start: April 2007; expected completion: December 2007
- Conditions
- Uncomplicated Malaria
- Being tested
- sulfadoxine-pyrimethamine, artemether-lumefantrine, amodiaquine-artesunate coformulation
- Keywords
- uncomplicated malaria, children, treatment, effectiveness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sulfadoxine-pyrimethamineDrug
Also called Fansidar
tablets 1,25/25 mg
1 tablet per 20 kg of body weight Single drug intake
artemether-lumefantrineDrug
Also called coartem
tablets 20/120 mg
- 1 tablet twice daily for 3 days below 15 kg of bodyweight
- 2 tablets twice daily for 3 days below 24 kg of bodyweight
- 3 tablets twice daily for 3 days below 35 kg of bodyweight
amodiaquine-artesunate coformulationDrug
Also called coarsucam
one 25mg/67,5mg tablet, once daily for 3 days below 9 kg
one 50/135mg tablet, once daily for 3 days below 18 kg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | sulfadoxine-pyrimethamine Receives: Drug: sulfadoxine-pyrimethamine |
| 2 | Active comparator | artemether-lumefantrine Receives: Drug: artemether-lumefantrine |
| 3 | Active comparator | amodiaquine-artesunate coformulation Receives: Drug: amodiaquine-artesunate coformulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy
Measured: day 28
Secondary outcomes (2)
effectiveness comparisons (PCR corrected)
Measured: day 14 and day 42
incidence of adverse events
Measured: day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionNov 2007
- Study completionNov 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 Uncomplicated MalariaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche pour le Developpement
- Sponsor type
- Other government
- Investigators
- Jean-François Faucher, MD PhD, Principal investigator, Institut de recherche pour le développement UR010Philippe Deloron, MD PhD, Study director, Institut de Recherche pour le Développement UR010
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00460369
- Sponsor's protocol ID
- Malariallada
- Status last verified
- Apr 2008
- First submitted
- 12 Apr 2007
- Last updated
- 14 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Faucher JF, Aubouy A, Adeothy A, Cottrell G, Doritchamou J, Gourmel B, Houze P, Kossou H, Amedome H, Massougbodji A, Cot M, Deloron P. Comparison of sulfadoxine-pyrimethamine, unsupervised artemether-lumefantrine, and unsupervised artesunate-amodiaquine fixed-dose formulation for uncomplicated plasmodium falciparum malaria in Benin: a randomized effectiveness noninferiority trial. J Infect Dis. 2009 Jul 1;200(1):57-65. doi: 10.1086/599378.
PubMed 19469703
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sulfadoxine-Pyrimethamine Versus Artemether-Lumefantrine Versus Amodiaquine-Artesunate Coformulation in Uncomplicated Plasmodium Falciparum Malaria : an Open Randomized Study
- ClinicalTrials.gov ID
- NCT00460369
- Acronym / sponsor ID
- Malariallada
- Conditions
- Uncomplicated Malaria
- Keywords
- uncomplicated malaria, children, treatment, effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Institut de Recherche pour le DeveloppementOther government
- Study start
- Apr 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 13 Apr 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.
Malaria is a life-threatening disease especially in small children. A high degree of Plasmodium falciparum resistance to chloroquine has already spread to South-Benin where this study is taking place. In the past few years, the recommendation for a first-line treatment in this area has moved from chloroquine to sulfadoxine-pyrimethamine (SP). There is growing evidence that Plasmodium falciparum resistance to SP has come to South-Benin. The aim of the study is to compare the efficacy of SP to two compact artemisinin-based therapies (ACT): artemether-lumefantrine and the amodiaquine-artesunate coformulation. ACT will be unsupervised.
The primary endpoint is an effectiveness comparison (PCR corrected) at day 28. Secondary outcomes are effectiveness comparisons (PCR corrected) at day 14 and 42 and a study on the relationships between ACT PK data (day 3) and outcome.
Expected total enrollment: 225 patients
Study start: April 2007; expected completion: December 2007
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: sulfadoxine-pyrimethaminesulfadoxine-pyrimethamine |
| 2 | Active comparator | Drug: artemether-lumefantrineartemether-lumefantrine |
| 3 | Active comparator | Drug: amodiaquine-artesunate coformulationamodiaquine-artesunate coformulation |
Who may qualify
- Ages
- 6 to 119 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 6-119 months old
- fever or history of fever of less than 24 hours
- p falciparum parasitemia > 1000 trophozoïtes/µL
- informed consent signed
Key exclusion criteria (5 listed)
- < 5 kg
- danger or severity signs of malaria
- known underlying chronic disease
- Hb < 5g/dL
- adequate malaria treatment taken within 3 days before visit
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 |
|---|---|---|
| sulfadoxine-pyrimethamineAlso: Fansidartablets 1,25/25 mg 1 tablet per 20 kg of body weight Single drug intake | Drug | 1 |
| artemether-lumefantrineAlso: coartemtablets 20/120 mg * 1 tablet twice daily for 3 days below 15 kg of bodyweight * 2 tablets twice daily for 3 days below 24 kg of bodyweight * 3 tablets twice daily for 3 days below 35 kg of bodyweight | Drug | 2 |
| amodiaquine-artesunate coformulationAlso: coarsucamone 25mg/67,5mg tablet, once daily for 3 days below 9 kg one 50/135mg tablet, once daily for 3 days below 18 kg | Drug | 3 |
Primary outcome
efficacy
Time frame: day 28
2 secondary outcomes
effectiveness comparisons (PCR corrected)
Time frame: day 14 and day 42
incidence of adverse events
Time frame: day 42
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 Apr 2008.
- Derived from this study: PubMed 19469703Faucher JF, Aubouy A, Adeothy A, Cottrell G, Doritchamou J, Gourmel B, Houze P, Kossou H, Amedome H, Massougbodji A, Cot M, Deloron P. Comparison of sulfadoxine-pyrimethamine, unsupervised artemether-lumefantrine, and unsupervised artesunate-amodiaquine fixed-dose formulation for uncomplicated plasmodium falciparum malaria in Benin: a randomized effectiveness noninferiority trial. J Infect Dis. 2009 Jul 1;200(1):57-65. doi: 10.1086/599378.
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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.
Jean-François Faucher, MD PhD principal investigator
Institut de recherche pour le développement UR010
Philippe Deloron, MD PhD study director
Institut de Recherche pour le Développement UR010
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sulfadoxine-pyrimethamine, artemether-lumefantrine and amodiaquine-artesunate coformulation in people with Uncomplicated Malaria, run by Institut de Recherche pour le Developpement at 1 site in Benin.
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 4 inclusion and 5 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 Apr 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 Benin. 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?
efficacy (time frame: day 28). 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 NCT00460369, 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 14 Apr 2008.