MalariaPhase 3NCT00386763
Efficacy and Safety of the Pediatric Formulation of Artemether- Lumefantrine in Children With Uncomplicated P. Falciparum Malaria.
A Phase 3 study testing Artemether-lumefantrine in people with Malaria and Falciparum, run by Novartis at 5 sites in 5 countries.
Trial summary
This study will evaluate the safety and efficacy of artemether-lumefantrine against uncomplicated malaria caused P. falciparum in children of 5-35 kg bodyweight. Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Malaria, Falciparum
- What is being tested?
- Artemether-lumefantrine
- How many people
- 890 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Aug 2006to Mar 2007
- 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 Up to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- male or female infants and children ≤12 years of age
- body weight of ≥5 kg and <35 kg,
- with a confirmed diagnosis of uncomplicated malaria caused by the P. falciparum parasite
Who cannot join
- complicated malaria
- persistent vomiting
- malaria due to parasites other than P. falciparum
- antimalarial treatment received in the past 2 weeks
- known chronic disease e.g. positive HIV status, severe cardiac, renal, or hepatic disease
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
About this study
Official title: A Randomized, Investigator-Blinded, Multicenter, Parallel-Group Study to Compare Efficacy, Safety and Tolerability of Arthemeter/ Lumefantrine Dispersible Tablet Formulation vs. Artemether/ Lumefantrine 6-Dose Crushed Tablet in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Infants and Children.
This study will evaluate the safety and efficacy of artemether-lumefantrine against uncomplicated malaria caused P. falciparum in children of 5-35 kg bodyweight.
- Conditions
- Malaria, Falciparum
- Being tested
- Artemether-lumefantrine
- Keywords
- Marsh fever, Plasmodium infections, Remittent fever, Paludism, Artemether, Artemisinins, Malaria, Benflumetol, Lumefantrine
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artemether-lumefantrineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients free of parasites at day 28.
Secondary outcomes (5)
Proportion of patients free of parasites at 7 days and at 14 days
Time to clearance from parasites
Time to clearance of fever
Hematology and biochemistry parameters
Electrocardiogram
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2006 (estimated)
- Study startAug 2006
- Study completionMar 2007
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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 890 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study chair, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00386763
- Sponsor's protocol ID
- CCOA566B2303
- Status last verified
- Mar 2009
- First submitted
- 11 Oct 2006
- Last updated
- 12 Mar 2009
- Results posted
- No
Publications
Belard S, Ramharter M, Kurth F. Paediatric formulations of artemisinin-based combination therapies for treating uncomplicated malaria in children. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD009568. doi: 10.1002/14651858.CD009568.pub2.
PubMed 33289099Abdulla S, Sagara I, Borrmann S, D'Alessandro U, Gonzalez R, Hamel M, Ogutu B, Martensson A, Lyimo J, Maiga H, Sasi P, Nahum A, Bassat Q, Juma E, Otieno L, Bjorkman A, Beck HP, Andriano K, Cousin M, Lefevre G, Ubben D, Premji Z. Efficacy and safety of artemether-lumefantrine dispersible tablets compared with crushed commercial tablets in African infants and children with uncomplicated malaria: a randomised, single-blind, multicentre trial. Lancet. 2008 Nov 22;372(9652):1819-27. doi: 10.1016/S0140-6736(08)61492-0. Epub 2008 Oct 14.
PubMed 18926569
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Investigator-Blinded, Multicenter, Parallel-Group Study to Compare Efficacy, Safety and Tolerability of Arthemeter/ Lumefantrine Dispersible Tablet Formulation vs. Artemether/ Lumefantrine 6-Dose Crushed Tablet in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Infants and Children.
- ClinicalTrials.gov ID
- NCT00386763
- Acronym / sponsor ID
- CCOA566B2303
- Conditions
- Malaria, Falciparum
- Keywords
- Marsh fever, Plasmodium infections, Remittent fever, Paludism, Artemether, Artemisinins, Malaria, Benflumetol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 890 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Study completion
- Mar 2007
- First posted
- 12 Oct 2006 (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.
This study will evaluate the safety and efficacy of artemether-lumefantrine against uncomplicated malaria caused P. falciparum in children of 5-35 kg bodyweight.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- male or female infants and children ≤12 years of age
- body weight of ≥5 kg and <35 kg,
- with a confirmed diagnosis of uncomplicated malaria caused by the P. falciparum parasite
Key exclusion criteria (5 listed)
- complicated malaria
- persistent vomiting
- malaria due to parasites other than P. falciparum
- antimalarial treatment received in the past 2 weeks
- known chronic disease e.g. positive HIV status, severe cardiac, renal, or hepatic disease
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 |
|---|---|---|
| Artemether-lumefantrine | Drug | – |
Primary outcome
Proportion of patients free of parasites at day 28.
5 secondary outcomes
Proportion of patients free of parasites at 7 days and at 14 days
Time to clearance from parasites
Time to clearance of fever
Hematology and biochemistry parameters
Electrocardiogram
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 12 Mar 2009.
- Derived from this study: PubMed 33289099Belard S, Ramharter M, Kurth F. Paediatric formulations of artemisinin-based combination therapies for treating uncomplicated malaria in children. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD009568. doi: 10.1002/14651858.CD009568.pub2.
- Derived from this study: PubMed 18926569Abdulla S, Sagara I, Borrmann S, D'Alessandro U, Gonzalez R, Hamel M, Ogutu B, Martensson A, Lyimo J, Maiga H, Sasi P, Nahum A, Bassat Q, Juma E, Otieno L, Bjorkman A, Beck HP, Andriano K, Cousin M, Lefevre G, Ubben D, Premji Z. Efficacy and safety of artemether-lumefantrine dispersible tablets compared with crushed commercial tablets in African infants and children with uncomplicated malaria: a randomised, single-blind, multicentre trial. Lancet. 2008 Nov 22;372(9652):1819-27. doi: 10.1016/S0140-6736(08)61492-0. Epub 2008 Oct 14.
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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.
Novartis Pharmaceuticals study chair
Novartis Pharmaceuticals
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Artemether-lumefantrine in people with Malaria and Falciparum, run by Novartis at 5 sites in 5 countries.
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 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 12 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Benin, Kenya, Mali, Mozambique, Tanzania. 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?
Proportion of patients free of parasites at 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 NCT00386763, 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 12 Mar 2009.