Acute Uncomplicated Falciparum MalariaPhase 2/3NCT01619878
Efficacy, Safety and Pharmacokinetics of Artemether-lumefantrine Dispersible Tablet in the Treatment of Malaria in Infants < 5 kg
A Phase 2/3 study testing Artemether-lumefantrine (COA566) in people with Acute Uncomplicated Falciparum Malaria, run by Novartis Pharmaceuticals at 7 sites in 5 countries.
Trial summary
The purpose of the study is to obtain efficacy, safety and pharmacokinetic (PK) data following treatment with artemether-lumefantrine dispersible tablet in infants < 5 kg of body weight (BW) with uncomplicated falciparum malaria. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Uncomplicated Falciparum Malaria
- What is being tested?
- Artemether-lumefantrine (COA566)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 7 sitesin 5 countries
- Study dates
- Oct 2012to Jul 2014
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Neonates / infants
- Body weight < 5 kg
- In cohort 1, infants aged > 28 days; in cohort 2, neonates of a term age 0 to ≤ 28 days
- Microscopically confirmed diagnosis of acute uncomplicated Plasmodium falciparum malaria or mixed infections with an asexual Plasmodium falciparum parasitaemia of > 1,000 and < 100,000 parasites/µL
Who cannot join
- Presence of severe malaria (according to World Health Organization definition)
- Presence of the following signs of a critical condition: apnea-bradycardia, sustained bradycardia, tachycardia, desaturation, hypotension, hypothermia; or other severely deteriorated general condition (based on IMCI criteria in sick infants)
- Presence of any clinically significant neurological condition
- Presence of clinically significant abnormality of the hepatic and renal systems
- Patients who sustained a significant blood volume loss (> 3% of calculated blood volume) in the past 30 days
- Patients unable to swallow or whose drinking is impaired
Show all 10Show fewer
- Family history of congenital prolongation of the QTc interval or sudden death or with any other clinical condition known to be associated with prolongation of the QTc interval such as history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease
- Disturbances of electrolyte balance (e.g. hypokalaemia or hypomagnesaemia)
- Presence of any age-adjusted clinically or hematologically relevant laboratory and blood chemistry abnormalities
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
Benin2 sites
Novartis Investigative Site
Cotonou, 01 BP 107
Novartis investigative site
Cotonou
Burkina Faso2 sites
Novartis Investigative Site
Burkina Faso, 2208
Novartis investigative site
Ouagadougou
Republic of the Congo1 site
Novartis investigative site
Kinshasa
Togo1 site
Novartis investigative site
Lomé
About this study
Official title: An Open-label, Single-arm Study to Evaluate the Efficacy, Safety and PK of Artemether-lumefantrine Dispersible Tablet in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Infants <5 kg Body Weight
The purpose of the study is to obtain efficacy, safety and pharmacokinetic (PK) data following treatment with artemether-lumefantrine dispersible tablet in infants < 5 kg of body weight (BW) with uncomplicated falciparum malaria.
- Conditions
- Acute Uncomplicated Falciparum Malaria
- Being tested
- Artemether-lumefantrine (COA566)
- Keywords
- plasmodium, P. falciparum, malaria, infant, neonate
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artemether-lumefantrine (COA566)Drug
Also called Artemether-lumefantrine, COA566
One dispersible tablet taken orally twice a day during 3 days.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.
Infants age >28 days. Receives: Drug: Artemether-lumefantrine (COA566) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polymerase Chain Reaction (PCR) Corrected 28 Day Parasitological Cure Rate
Number of participants with clearance of asexual parasites by day 7 after initiating study treatment without recrudescence at day 28, corrected for re-infection by Polymerase Chain Reaction (PCR) assay.
Measured: 28 days
Secondary outcomes (8)
Polymerase Chain Reaction (PCR) Corrected Parasitological Cure Rate at Day 14 and 42
Number of participants with clearance of asexual parasites by day 7 after initiating study treatment without recrudescence at day 14 and day 42, corrected for re-infection by Polymerase Chain Reaction (PCR) assay.
Measured: Day 14 and 42
Number of Participants With Parasitological Uncorrected Cure Rate at Day 3, 7, 14, 28 and 42
Number of patients with clearance of asexual parasites at day 3, 7, 14, 28 and 42 after initiating study treatment.
Measured: Day 3, 7, 14, 28 and 42
Percent Change of Parasite Count From Baseline at 24 Hours
Percent change of parasite count from baseline at 24 hours
Measured: baseline, 24 hours
Number of Participants With Parasitaemia at 48 Hours After Treatment Initiation Greater Than at Baseline
Number of participants with parasite density at 48 hours after treatment initiation greater than parasite density at baseline.
Measured: 48 hours
Number of Participants With Parasitaemia at 72 Hours After Treatment Initiation Greater Than or Equal to 25 Percent of Count at Baseline
Number of participants with parasite density at 72 hours after treatment initiation greater than or equal to 25 percent of parasite density at baseline.
Measured: 72 hours
Time to Parasite Clearance (PCT)
Time from first dose until first total and continued disappearance of asexual parasite forms which remains at least a further 48 hours.
Measured: Up to 7 days
Time to Fever Clearance (FCT)
Time from first dose to the first time the axillary body temperature decreased below and remained below 37.5° C for at least 48 hours.
Measured: Up to 7 days
Time to Gametocyte Clearance (GCT)
Time from first dose until first total and continued disappearance of gametocytes which remains at least a further 48 hours.
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2012 (estimated)
- Study startOct 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Uncomplicated Falciparum MalariaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medicines for Malaria Venture
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01619878
- Sponsor's protocol ID
- CCOA566B2306
- Other IDs
- 2011-005852-33, 2011-005858-33
- Status last verified
- Jun 2015
- First submitted
- 12 Jun 2012
- Last updated
- 17 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Tiono AB, Tinto H, Alao MJ, Meremikwu M, Tshefu A, Ogutu B, Ouedraogo A, Lingani M, Cousin M, Lefevre G, Jain JP, Duparc S, Hamed K. Increased systemic exposures of artemether and dihydroartemisinin in infants under 5 kg with uncomplicated Plasmodium falciparum malaria treated with artemether-lumefantrine (Coartem(R)). Malar J. 2015 Apr 15;14:157. doi: 10.1186/s12936-015-0682-7.
PubMed 25886021
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm Study to Evaluate the Efficacy, Safety and PK of Artemether-lumefantrine Dispersible Tablet in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Infants <5 kg Body Weight
- ClinicalTrials.gov ID
- NCT01619878
- Acronym / sponsor ID
- CCOA566B2306
- Conditions
- Acute Uncomplicated Falciparum Malaria
- Keywords
- plasmodium, P. falciparum, malaria, infant, neonate
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Medicines for Malaria Venture
- Study start
- Oct 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 14 Jun 2012 (estimated)
- Results
- Posted 17 Jun 2015
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 the study is to obtain efficacy, safety and pharmacokinetic (PK) data following treatment with artemether-lumefantrine dispersible tablet in infants < 5 kg of body weight (BW) with uncomplicated falciparum malaria.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Artemether-lumefantrine (COA566)One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days. Infants age >28 days. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Neonates / infants
- Body weight < 5 kg
- In cohort 1, infants aged > 28 days; in cohort 2, neonates of a term age 0 to ≤ 28 days
- Microscopically confirmed diagnosis of acute uncomplicated Plasmodium falciparum malaria or mixed infections with an asexual Plasmodium falciparum parasitaemia of > 1,000 and < 100,000 parasites/µL
Key exclusion criteria (10 listed)
- Presence of severe malaria (according to World Health Organization definition)
- Presence of the following signs of a critical condition: apnea-bradycardia, sustained bradycardia, tachycardia, desaturation, hypotension, hypothermia; or other severely deteriorated general condition (based on IMCI criteria in sick infants)
- Presence of any clinically significant neurological condition
- Presence of clinically significant abnormality of the hepatic and renal systems
- Patients who sustained a significant blood volume loss (> 3% of calculated blood volume) in the past 30 days
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 (COA566)Also: Artemether-lumefantrine, COA566One dispersible tablet taken orally twice a day during 3 days. | Drug | Cohort 1 |
Primary outcome
Polymerase Chain Reaction (PCR) Corrected 28 Day Parasitological Cure Rate
Time frame: 28 days
Number of participants with clearance of asexual parasites by day 7 after initiating study treatment without recrudescence at day 28, corrected for re-infection by Polymerase Chain Reaction (PCR) assay.
8 secondary outcomes
Polymerase Chain Reaction (PCR) Corrected Parasitological Cure Rate at Day 14 and 42
Time frame: Day 14 and 42
Number of Participants With Parasitological Uncorrected Cure Rate at Day 3, 7, 14, 28 and 42
Time frame: Day 3, 7, 14, 28 and 42
Percent Change of Parasite Count From Baseline at 24 Hours
Time frame: baseline, 24 hours
Number of Participants With Parasitaemia at 48 Hours After Treatment Initiation Greater Than at Baseline
Time frame: 48 hours
Number of Participants With Parasitaemia at 72 Hours After Treatment Initiation Greater Than or Equal to 25 Percent of Count at Baseline
Time frame: 72 hours
Time to Parasite Clearance (PCT)
Time frame: Up to 7 days
Time to Fever Clearance (FCT)
Time frame: Up to 7 days
Time to Gametocyte Clearance (GCT)
Time frame: Up to 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25886021Tiono AB, Tinto H, Alao MJ, Meremikwu M, Tshefu A, Ogutu B, Ouedraogo A, Lingani M, Cousin M, Lefevre G, Jain JP, Duparc S, Hamed K. Increased systemic exposures of artemether and dihydroartemisinin in infants under 5 kg with uncomplicated Plasmodium falciparum malaria treated with artemether-lumefantrine (Coartem(R)). Malar J. 2015 Apr 15;14:157. doi: 10.1186/s12936-015-0682-7.
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 director
Novartis Pharmaceuticals
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Artemether-lumefantrine (COA566) in people with Acute Uncomplicated Falciparum Malaria, run by Novartis Pharmaceuticals at 7 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 4 inclusion and 10 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 17 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Benin, Burkina Faso, Nigeria, Republic of the Congo, Togo. 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?
Yes. Results are posted in the registry (first posted 17 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Polymerase Chain Reaction (PCR) Corrected 28 Day Parasitological Cure Rate (time frame: 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 NCT01619878, 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 17 Jun 2015.