Malaria, FalciparumPhase 4NCT00529867
Randomised Efficacy Study of Two Artemether-Lumefantrine Oral Formulations for the Treatment of Uncomplicated P. Falciparum Malaria
A Phase 4 study testing Artemether/lumefantrine tablets and Artemether/Lumefantrine suspension in people with Malaria, Falciparum, run by Dafra Pharma at 1 site in Kenya.
Trial summary
The purpose of this study is to compare the safety and efficacy in children aged 6 - 59 months with uncomplicated malaria, treated with either conventional artemether/lumefantrine tablets(Coartem®) or artemether/ lumefantrine suspension (Co-artesiane®) in Western Kenya Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Malaria, Falciparum
- What is being tested?
- Artemether/lumefantrine tablets and Artemether/Lumefantrine suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 1 siteKenya
- Study dates
- May 2007to Dec 2007
- Phase
- Phase 4
- 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 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged between 6 and 59 months
- Minimum body weight of 5kg
- Presence of fever (Temp >/= 37.5°C) or a history of fever in the last 24 hours
- Presence of asexual P. falciparum monoinfection
- Initial parasite density of between 2,000 and 200,000 asexual parasites/µl of blood
- Not suffering from severe and complicated forms of malaria
- Able to take drugs under study by the oral route
- Parent or guardian gives informed written consent to participate in study
Who cannot join
- Severe and/or complicated malaria (WHO, 2000 classification), including severe anaemia (Hb =/<5 g/dl), two or more seizures in last 24 hrs and hyper-parasitaemia (>200,000 µl)
- Patients treated with mefloquine, halofantrine within the 7 days before Day 0 or with quinine salts and artemisinin derivatives within 3 days before Day 0, or artemether-lumefantrine 30 days before Day 0
- Patients who require intensive care for malaria or another severe concomitant illness capable of interfering with the clinical evolution of malaria
- Patients with vomiting and/or diarrhoea
- Signs of severe malnutrition (defined as follows: 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)
- Presence of general danger signs in children below 5 years or other signs of serious and complex Plasmodium falciparum, as stated in the present WHO definitions
- Patients with known history of heart disease or arrhythmia
- History of allergy to artemether/lumefantrine or quinine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Open-Label Trial of the Efficacy of Artemether-Lumefantrine Suspension Compared With Artemether-Lumefantrine Tablets for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Less Than Five Years in Western Kenya
The purpose of this study is to compare the safety and efficacy in children aged 6 - 59 months with uncomplicated malaria, treated with either conventional artemether/lumefantrine tablets(Coartem®) or artemether/ lumefantrine suspension (Co-artesiane®) in Western Kenya
- Conditions
- Malaria, Falciparum
- Being tested
- Artemether/lumefantrine tablets, Artemether/Lumefantrine suspension
- Keywords
- Artemether/Lumefantrine suspension, P. falciparum malaria, children, uncomplicated Plasmodium falciparum malaria
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artemether/lumefantrine tabletsDrug
Also called Coartem
Artemether/lumefantrine tablets containing 20mg artemether and 120mg lumefantrine
Dosage: 5 - 14.9 kg: 1 tablet and 15 - 24.9 kg: 2 tablets
Administered at 0, 8, 24, 36, 48, and 60 hours on days 0, 1, and 2
Artemether/Lumefantrine suspensionDrug
Also called Co-Artesiane suspension
Artemether/lumefantrine suspension containing 15mg artemether and 90mg lumefantrine per 5ml suspension
Dosage: 5.0 - 7.4 kg = 7 ml, 7.5 - 9.9 kg = 10 ml, 10 - 12.4 kg = 14 ml, 12.5 - 14.9 kg = 17 ml, 15 - 17.4 kg = 20 ml, 17.5 - 19.9 kg = 24 ml, 20 - 22.4 kg = 27 ml and 22.5 - 24.9 kg = 30 ml
Administered once daily at 0, 24, and 48 hours on days 0, 1 and 2
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: Artemether/lumefantrine tablets |
| B | Active comparator | Not described Receives: Drug: Artemether/Lumefantrine suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare PCR corrected cure-rates on day 14 and 28
Measured: 1 year
Secondary outcomes (3)
To determine and compare Adequate Clinical and Parasitological Response (ACPR) at days 14 and 28
Measured: 28 days
To determine and compare proportion of children with gametocytes on days 0, 7, 14, and 28
Measured: 28 days
Monitor any possible adverse reactions following use of both drugs
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2007 (estimated)
- Study startMay 2007
- Primary completionDec 2007
- Study completionDec 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 Malaria, FalciparumStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dafra Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kenya Medical Research Institute
- Investigators
- Elizabeth A Juma, Dr., Principal investigator, Kenya Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00529867
- Sponsor's protocol ID
- SSC protocol No. 1210
- Status last verified
- Jan 2008
- First submitted
- 12 Sep 2007
- Last updated
- 18 Jan 2008
- Results posted
- No
- Data monitoring committee
- 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 33289099Juma EA, Obonyo CO, Akhwale WS, Ogutu BR. A randomized, open-label, comparative efficacy trial of artemether-lumefantrine suspension versus artemether-lumefantrine tablets for treatment of uncomplicated Plasmodium falciparum malaria in children in western Kenya. Malar J. 2008 Dec 22;7:262. doi: 10.1186/1475-2875-7-262.
PubMed 19102746
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
- A Randomized Open-Label Trial of the Efficacy of Artemether-Lumefantrine Suspension Compared With Artemether-Lumefantrine Tablets for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Less Than Five Years in Western Kenya
- ClinicalTrials.gov ID
- NCT00529867
- Acronym / sponsor ID
- SSC protocol No. 1210
- Conditions
- Malaria, Falciparum
- Keywords
- Artemether/Lumefantrine suspension, P. falciparum malaria, children, uncomplicated Plasmodium falciparum malaria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Dafra PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Kenya Medical Research Institute
- Study start
- May 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 14 Sep 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 compare the safety and efficacy in children aged 6 - 59 months with uncomplicated malaria, treated with either conventional artemether/lumefantrine tablets(Coartem®) or artemether/ lumefantrine suspension (Co-artesiane®) in Western Kenya
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Artemether/lumefantrine tablets |
| B | Active comparator | Drug: Artemether/Lumefantrine suspension |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Children aged between 6 and 59 months
- Minimum body weight of 5kg
- Presence of fever (Temp >/= 37.5°C) or a history of fever in the last 24 hours
- Presence of asexual P. falciparum monoinfection
- Initial parasite density of between 2,000 and 200,000 asexual parasites/µl of blood
Key exclusion criteria (8 listed)
- Severe and/or complicated malaria (WHO, 2000 classification), including severe anaemia (Hb =/<5 g/dl), two or more seizures in last 24 hrs and hyper-parasitaemia (>200,000 µl)
- Patients treated with mefloquine, halofantrine within the 7 days before Day 0 or with quinine salts and artemisinin derivatives within 3 days before Day 0, or artemether-lumefantrine 30 days before Day 0
- Patients who require intensive care for malaria or another severe concomitant illness capable of interfering with the clinical evolution of malaria
- Patients with vomiting and/or diarrhoea
- Signs of severe malnutrition (defined as follows: 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 |
|---|---|---|
| Artemether/lumefantrine tabletsAlso: CoartemArtemether/lumefantrine tablets containing 20mg artemether and 120mg lumefantrine Dosage: 5 - 14.9 kg: 1 tablet and 15 - 24.9 kg: 2 tablets Administered at 0, 8, 24, 36, 48, and 60 hours on days 0, 1, and 2 | Drug | A |
| Artemether/Lumefantrine suspensionAlso: Co-Artesiane suspensionArtemether/lumefantrine suspension containing 15mg artemether and 90mg lumefantrine per 5ml suspension Dosage: 5.0 - 7.4 kg = 7 ml, 7.5 - 9.9 kg = 10 ml, 10 - 12.4 kg = 14 ml, 12.5 - 14.9 kg = 17 ml, 15 - 17.4 kg = 20 ml, 17.5 - 19.9 kg = 24 ml, 20 - 22.4 kg = 27 ml and 22.5 - 24.9 kg = 30 ml Administered once daily at 0, 24, and 48 hours on days 0, 1 and 2 | Drug | B |
Primary outcome
To compare PCR corrected cure-rates on day 14 and 28
Time frame: 1 year
3 secondary outcomes
To determine and compare Adequate Clinical and Parasitological Response (ACPR) at days 14 and 28
Time frame: 28 days
To determine and compare proportion of children with gametocytes on days 0, 7, 14, and 28
Time frame: 28 days
Monitor any possible adverse reactions following use of both drugs
Time frame: 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 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 19102746Juma EA, Obonyo CO, Akhwale WS, Ogutu BR. A randomized, open-label, comparative efficacy trial of artemether-lumefantrine suspension versus artemether-lumefantrine tablets for treatment of uncomplicated Plasmodium falciparum malaria in children in western Kenya. Malar J. 2008 Dec 22;7:262. doi: 10.1186/1475-2875-7-262.
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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.
Elizabeth A Juma, Dr. principal investigator
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 4 study testing Artemether/lumefantrine tablets and Artemether/Lumefantrine suspension in people with Malaria, Falciparum, run by Dafra Pharma 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 8 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 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 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
To compare PCR corrected cure-rates on day 14 and 28 (time frame: 1 year). 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 NCT00529867, 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 18 Jan 2008.