Malaria (Uncomplicated)NCT06970600
Efficacy of Artemether-Lumefantrine in the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Under 12 Years at Four Sentinel Sites in Mozambique
A study testing Artemether-lumefantrine (Coartem) in people with Malaria (Uncomplicated), run by Centro de Investigacao em Saude de Manhica at 4 sites in Mozambique.
Trial summary
This is a classical in vivo clinical trial, following World Health organization's recommendations, ran as a multisite study within Mozambique trying to assess the efficacy and safety in four sites of artemether-lumefantrine (AL) combination for the treatment of uncomplicated malaria in children aged<12 years. Read more about this study
- Who is it for?
- Ages 6 months to 11 years
- Conditions the study is for
- Malaria (Uncomplicated)
- What is being tested?
- Artemether-lumefantrine (Coartem)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 4 sitesMozambique
- Study dates
- 7 Mar 2024to 31 Jan 2025
- 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 months to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages 6 to 143 months
- Weight Greater than or equal to 5 kg
- Absence of severe malnutrition;
- Mono-infection with Plasmodium falciparum in blood, confirmed by microscopy;
- Parasite density between 1,000 and 200,000 asexual parasites per microliter of blood;
- Haemoglobin ≥ 7.0 g/dl;
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- Axillary temperature ≥ 37.5 C° or history of fever in the last 24 hours;
- Lack of danger signs, or no signs of severe and / or complicated malaria according to the WHO definition
- Ability to swallow the drugs
- Residents within the study area and have the possibility of an adequate follow-up in the days of monitoring for a period of 28 days;
- Absence of a history of hypersensitivity to study medications;
- Informed consent of parents, guardians or caregivers (legal guardian) after explaining the purpose of the study.
Who cannot join
- Presence of any danger sign or severe or complicated Plasmodium falciparum malaria according to WHO definitions;
- Presence of fever due to diseases other than malaria (eg measles, acute respiratory infection, severe diarrhea with dehydration) or other known diseases, with chronic or serious illnesses (cardiac, renal, hepatic or known infection with HIV AIDS);
- Presence of severe malnutrition (defined as a child whose growth pattern is below the 3rd percentile, mid-upper-arm circumference <110mm, weight / height <70% according to the WHO tables, or the presence of bilateral edema of the lower limbs);
- Multi or mono-infection by another Plasmodium species detected by microscopy;
- Regular medication that may interfere with the pharmacokinetics of antimalarials;
- History of hypersensitivity or contraindication to study drug;
- A history of taking antimalarial drugs or drugs with antimalarial activity in less than 7 days.
- Continuous prophylaxis with cotrimoxazole in HIV positive children.
Trial locations and contacts
4 sites in 1 country.
Mozambique4 sites
Hospital Rural de Cuamba
Cuamba, Niassa Province
Hospital Distrital de Dondo
Dondo, Sofala
Hospital Distrital de Massinga
Massinga, Inhambane Province
Hospital Distrital de Mopeia
Mopeia, Zambezia Province
About this study
Official title: Monitoring the Therapeutic Efficacy of Artemether-Lumefantrine Combination in the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Under 12 Years of Age at Four Sentinel Sites in Mozambique
This is a classical in vivo clinical trial, following World Health organization's recommendations, ran as a multisite study within Mozambique trying to assess the efficacy and safety in four sites of artemether-lumefantrine (AL) combination for the treatment of uncomplicated malaria in children aged<12 years. The goal of this study is to evaluate the clinical and parasitological efficacy of the study drug combinations in children aged between 6 - 143 months, suffering from uncomplicated P. falciparum malaria, by determining the proportion with early treatment failure (ETF), late clinical failure (LCF), late parasitological failure (LPF) or an adequate clinical and parasitological response (ACPR) as indicators of efficacy. The participants will take AL for three days and followed-up for 28 days.
Read the detailed description
Eligible patients were consecutively assigned to the cohort and treated with AL. AL (Coartem™) will be administered twice daily for three days (six doses in total) with dosage determined according to body weight: one tablet (20mg artemether and 120mg lumefantrine) for children 5 to <15kg, two tablets per dose for those 15 to <25kg, and three tablets per dose for those 25 to <35kg. All treatments will be directly observed for a minimum of 30 minutes. Vomiting occurring within the first 30 minutes implied the repetition of the full dose of treatment. For those patients living far away from the health facilities, and for which direct observation of the evening doses of AL was challenging, admission was offered for the first three days of the study. Then after first four days, the patients were followed-up weekly ( clinical and laboratory assessment) until day 28.
- Conditions
- Malaria (Uncomplicated)
- Being tested
- Artemether-lumefantrine (Coartem)
- Keywords
- Efficacy, Artemether-lumefantrine, Mozambique, Malaria
- 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 (Coartem)Drug
Eligible patients will be consecutively assigned to the four cohorts. Rescue therapy according to national malaria treatment guidelines will be also administered in cases of early or late treatment failure. Follow-up visits will take place on days 1, 2, 3, 7, 14,21 and 28 after enrolment or at any time point whenever the child is sick. Adverse events will be recorded and assessed for severity and association with study medication. Thick and thin Giemsa-stained blood slides will be prepared before each dose to be administered and at every follow-up visit of days 2, 3, 7, 14, 21, 28, 35 and 42. Blood samples for PCR analysis will be collected from every patient at baseline and at days 7, 14, 28, and 42 day of treatment failure or at any other unscheduled visit. To differentiate recrudescence from new infection by polymerase chain reaction (PCR) analysis.The Molecular markers associated with suboptimal response to ACTs will be investigated.
| Study group | Role | What they receive |
|---|---|---|
| Artemether-lumefantrine | Other | AL (Coartem™) will be administered twice daily for three days (six doses in total) with dosage determined according to body weight: one tablet (20mg artemether and 120mg lumefantrine) for children 5 to <15kg, two tablets per dose for those 15 to <25kg, and three tablets per dose for those 25 to <35kg. Receives: Drug: Artemether-lumefantrine (Coartem) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the Day 28, PCR corrected cure rates of artemether-lumefantrine.
This cure rate is defined as the proportion of patients with adequate clinical and parasitological response (ACPR) at Day 28, once PCR correction to differentiate recrudescences from new infections have been applied (and hence only considering as treatment failures those parasite recurrences confirmed as recrudescences).
Measured: 28 days
Secondary outcomes (4)
To evaluate the incidence of adverse events
Safety was assessed by administering a questionnaire about the nature and incidence of adverse events and serious adverse events. An adverse event is defined as any unfavorable, unintended sign, symptom, syndrome or disease that develops or worsens with the use of a medicinal product, regardless of whether it is related to the medicinal product.
Measured: 28 days
To evaluate the variation of the levels of haemoglobin during and after treatment
Haemoglobin levels were measured on Day 0, Day 14 and Day 28 using a haemoglobinometer and their levels were compared at these three points.
Measured: 28 days
Measuring the Day PCR uncorrected cure rates of Artemether-Lumefantrine.
This cure rate is defined as the proportion of patients with adequate clinical and parasitological response (ACPR) at Day 28, without PCR correction to differentiate recrudescences from new infections and hence considering as treatment failures all parasite recurrences.
Measured: 28 days
Evaluate the presence of Molecular Markers associated with sub optimum responses to ACTs
The presence of molecular marks is defined as presence of mutations in pfk13 and pfmdr1 (at codons 86, 184 and 1246) genes identified by Sanger sequencing of pre-treatment samples.
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 May 2025
- Study start7 Mar 2024
- Primary completion28 Oct 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria (Uncomplicated)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro de Investigacao em Saude de Manhica
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization (Mozambique), National Malaria Control Program, Instituto Nacional de Saúde, Mozambique
- Responsible party
- Principal investigator, Pedro Aide, Centro de Investigacao em Saude de Manhica
- Investigators
- Pedro Aide, MD, Msc, PhD, Principal investigator, Centro de Investigaçao em Saude de Manhiça
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970600
- Sponsor's protocol ID
- MEFI_V
- Other IDs
- SUB CONTRACT AGREEMENT #1
- Status last verified
- May 2025
- First submitted
- 6 May 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring the Therapeutic Efficacy of Artemether-Lumefantrine Combination in the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Under 12 Years of Age at Four Sentinel Sites in Mozambique
- ClinicalTrials.gov ID
- NCT06970600
- Acronym / sponsor ID
- MEFI_V
- Conditions
- Malaria (Uncomplicated)
- Keywords
- Efficacy, Artemether-lumefantrine, Mozambique, Malaria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Centro de Investigacao em Saude de ManhicaUniversity, hospital or other
- Collaborators
- World Health Organization (Mozambique), National Malaria Control Program, Instituto Nacional de Saúde, Mozambique
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 28 Oct 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 14 May 2025 (actual)
- 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 is a classical in vivo clinical trial, following World Health organization's recommendations, ran as a multisite study within Mozambique trying to assess the efficacy and safety in four sites of artemether-lumefantrine (AL) combination for the treatment of uncomplicated malaria in children aged<12 years. The goal of this study is to evaluate the clinical and parasitological efficacy of the study drug combinations in children aged between 6 - 143 months, suffering from uncomplicated P. falciparum malaria, by determining the proportion with early treatment failure (ETF), late clinical failure (LCF), late parasitological failure (LPF) or an adequate clinical and parasitological response (ACPR) as indicators of efficacy. The participants will take AL for three days and followed-up for 28 days.
Detailed description
Eligible patients were consecutively assigned to the cohort and treated with AL. AL (Coartem™) will be administered twice daily for three days (six doses in total) with dosage determined according to body weight: one tablet (20mg artemether and 120mg lumefantrine) for children 5 to <15kg, two tablets per dose for those 15 to <25kg, and three tablets per dose for those 25 to <35kg. All treatments will be directly observed for a minimum of 30 minutes. Vomiting occurring within the first 30 minutes implied the repetition of the full dose of treatment. For those patients living far away from the health facilities, and for which direct observation of the evening doses of AL was challenging, admission was offered for the first three days of the study. Then after first four days, the patients were followed-up weekly ( clinical and laboratory assessment) until day 28.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Artemether-lumefantrine | Other | Drug: Artemether-lumefantrine (Coartem)AL (Coartem™) will be administered twice daily for three days (six doses in total) with dosage determined according to body weight: one tablet (20mg artemether and 120mg lumefantrine) for children 5 to <15kg, two tablets per dose for those 15 to <25kg, and three tablets per dose for those 25 to <35kg. |
Who may qualify
- Ages
- 6 months to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Ages 6 to 143 months
- Weight Greater than or equal to 5 kg
- Absence of severe malnutrition;
- Mono-infection with Plasmodium falciparum in blood, confirmed by microscopy;
- Parasite density between 1,000 and 200,000 asexual parasites per microliter of blood;
Key exclusion criteria (8 listed)
- Presence of any danger sign or severe or complicated Plasmodium falciparum malaria according to WHO definitions;
- Presence of fever due to diseases other than malaria (eg measles, acute respiratory infection, severe diarrhea with dehydration) or other known diseases, with chronic or serious illnesses (cardiac, renal, hepatic or known infection with HIV AIDS);
- Presence of severe malnutrition (defined as a child whose growth pattern is below the 3rd percentile, mid-upper-arm circumference <110mm, weight / height <70% according to the WHO tables, or the presence of bilateral edema of the lower limbs);
- Multi or mono-infection by another Plasmodium species detected by microscopy;
- Regular medication that may interfere with the pharmacokinetics of antimalarials;
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 (Coartem)Eligible patients will be consecutively assigned to the four cohorts. Rescue therapy according to national malaria treatment guidelines will be also administered in cases of early or late treatment failure. Follow-up visits will take place on days 1, 2, 3, 7, 14,21 and 28 after enrolment or at any time point whenever the child is sick. Adverse events will be recorded and assessed for severity and association with study medication. Thick and thin Giemsa-stained blood slides will be prepared before each dose to be administered and at every follow-up visit of days 2, 3, 7, 14, 21, 28, 35 and 42. Blood samples for PCR analysis will be collected from every patient at baseline and at days 7, 14, 28, and 42 day of treatment failure or at any other unscheduled visit. To differentiate recrudescence from new infection by polymerase chain reaction (PCR) analysis.The Molecular markers associated with suboptimal response to ACTs will be investigated. | Drug | Artemether-lumefantrine |
Primary outcome
Measuring the Day 28, PCR corrected cure rates of artemether-lumefantrine.
Time frame: 28 days
This cure rate is defined as the proportion of patients with adequate clinical and parasitological response (ACPR) at Day 28, once PCR correction to differentiate recrudescences from new infections have been applied (and hence only considering as treatment failures those parasite recurrences confirmed as recrudescences).
4 secondary outcomes
To evaluate the incidence of adverse events
Time frame: 28 days
To evaluate the variation of the levels of haemoglobin during and after treatment
Time frame: 28 days
Measuring the Day PCR uncorrected cure rates of Artemether-Lumefantrine.
Time frame: 28 days
Evaluate the presence of Molecular Markers associated with sub optimum responses to ACTs
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 14 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
Pedro Aide, MD, Msc, PhD principal investigator
Centro de Investigaçao em Saude de Manhiça
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artemether-lumefantrine (Coartem) in people with Malaria (Uncomplicated), run by Centro de Investigacao em Saude de Manhica at 4 sites in Mozambique.
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 12 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 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Mozambique. 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?
Measuring the Day 28, PCR corrected cure rates of artemether-lumefantrine. (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2025.