MalariaPhase 4MEFI_IVNCT05343312
In Vivo Efficacy of Artemether-Lumefantrine, Amodiaquine-Artesunate, Dihydroartemisinin-Piperaquine, and Pironaridine-Artesunate in Mozambique
A Phase 4 study testing AL (Coartem), AS-AQ (Carsucam) and DHP in people with Malaria, run by Centro de Investigacao em Saude de Manhica at 5 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 5 sites of the four oral ACTS artemether-lumefantrine (AL), Amodiaquine-Artesunate (AQ-AS), Dihydroartemisinin-Piperaquine (DHP) and… Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Malaria
- What is being tested?
- AL (Coartem), AS-AQ (Carsucam) and DHP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 870 participants
- Where
- 5 sitesMozambique
- Study dates
- 16 Mar 2022to 30 Jul 2025
- 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
- Ages 6 to 59 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 2,000 and 200,000 asexual parasites per microliter of blood;
- Axillary temperature ≥ 37.5 C° or history of fever in the last 24 hours;
Show all 12Show fewer
- Lack of danger signs, or no signs of severe and / or complicated malaria according to the WHO definition
- Ability to swallow the drugs
- Haemoglobin greater than 5.0 g / dl
- 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
5 sites in 1 country.
5 sites in 1 country
Mozambique5 sites
Hospital Distrital de Dondo
Dondo, Sofala, 1999
Hospital Distrital de Mssinga
Massinga, Inhambane Province, 1999
Mospital Distrital de Moatize
Moatize, Tete, 1999
Hospital Rural de Montepuez
Montepuez, Cabo Delgado Province, 1999
Hospital Distrital de Mopeia
Mopeia, Zambezia Province, 1999
About this study
Official title: Monitoring the Therapeutic Efficacy of the Combinations Artemether-Lumefantrine, Amodiaquine-Artesunate, Dihydroartemisinin-Piperaquine, and Pironaridine-Artesunate in the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Under 5 Years of Age in Five 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 5 sites of the four oral ACTS artemether-lumefantrine (AL), Amodiaquine-Artesunate (AQ-AS), Dihydroartemisinin-Piperaquine (DHP) and Pironaridine-Artesunate for the treatment of uncomplicated malaria in children aged<5 years.
Read the detailed description
Eligible patients were consecutively assigned to the cohort and treated with AL (cohort 1), AQ-AS (cohort 2), DHP (cohort 3) and PA (cohort 4). 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. AQ-AS (Winthrop™) will be administered once daily according to body weight: one 25mg artesunate and 67.5mg amodiaquine tablet in children <9kg, one 50mg artesunate and 135mg amodiaquine tablet in children 9-17.9kg; and one 100mg artesunate and 270mg amodiaquine tablet in children >18-35kg. DHP will be administered once daily according to body weight: half tablet (40mg dihydroartemisinin e 320 mg piperaquine) for children 5 to < 10Kg, one tablet for per dose for those 10 < 20Kg and 2 tablets for 20 or more Kg. PA (granules 60mg pirinaridine +/20mg artesunate) will administered once daily according to body weight: 1 granule per dose for children 5 to < 8Kg, two for children 8 < 15Kg, three for those 15 < 20Kg. PA (180mg pyrinaridine+60 mg artesunate) one tablet for children 20 < 24Kg and two tablets for those 24 < 45Kg. 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.
- Conditions
- Malaria
- Being tested
- AL (Coartem), AS-AQ (Carsucam), DHP, PA
- Keywords
- Treatment, Artemisine-based combinations, children
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL (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. The Molecular markers associated with suboptimal response to ACTs will be investigated.
AS-AQ (Carsucam)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, 28, 35 and 42 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, and 28 day of treatment failure or at any other unscheduled visit. The Molecular markers associated with suboptimal response to ACTs will be investigated.
DHPDrug
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, 28, 35 and 42 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. The Molecular markers associated with suboptimal response to ACTs will be investigated.
PADrug
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, 28, 35 and 42 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. The Molecular markers associated with suboptimal response to ACTs will be investigated.
| Study group | Role | What they receive |
|---|---|---|
| Artemether-Lumefantrine (AL) | Active comparator | 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: AL (Coartem) |
| Amodiaquine-Artesunate (AS-AQ) | Active comparator | AQ-AS (Coarsucam™) will be administered once daily according to body weight: one 25mg artesunate and 67.5mg amodiaquine tablet in children <9kg, one 50mg artesunate and 135mg amodiaquine tablet in children 9-17.9kg; and one 100mg artesunate and 270mg amodiaquine tablet in children >18-35kg. Receives: Drug: AS-AQ (Carsucam) |
| Dihydroartimisin+Piperaquine (DHP) | Active comparator | DHP will be administered once daily according to body weight: tablet (40 mg dihydroartimisin+artesunate) half in children 5 < 10kg, one in children 10 < 20kg and 2 tablets for those children over 20 kg. Receives: Drug: DHP |
| Pyronaridine +Artesunate (PA) | Active comparator | PA will be administered once daily according to body weight: granule ( 60 mg pyronaridine + 20 artesunate), one in children 5 < 7kg, two in children 8 < 15kg and three in children 15 < 20kg. Tablets ( 180 mg pyronaridine+ 60 mg artesunate), one in children 20 < 24Kg and two in children 24 < 45Kg. Receives: Drug: PA |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the Day 28, PCR corrected cure rates of artemether-lumefantrine and Amodiaquine-artesunate.
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
To measure the Day 42, PCR corrected cure rates of Dihydroartemisinin-Piperaquine and Pironaridine-Artesunate
This cure rate is defined as the proportion of patients with adequate clinical and parasitological response (ACPR) at Day 42, 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: 42 days
Secondary outcomes (3)
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: 28/42 days
To measure the Day PCR uncorrected cure rates of Artemether-Lumefantrine, Amodiaquine-Artesunate, Dihydroartemisinin-Piperaquine, and Pironaridine-Artesunate.
This cure rate is defined as the proportion of patients with adequate clinical and parasitological response (ACPR) at Day 28/42, without PCR correction to differentiate recrudescences from new infections and hence considering as treatment failures all parasite recurrences.
Measured: 28/42 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: 28/42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start16 Mar 2022
- Primary completion30 Sep 2023
- Study completion30 Jul 2025
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 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 870 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro de Investigacao em Saude de Manhica
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05343312
- Sponsor's protocol ID
- 20/CNBS/22
- Acronym
- MEFI_IV
- Status last verified
- Aug 2025
- First submitted
- 18 Apr 2022
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nhama A, Chidimatembue A, Nhamussua L, Bassat Q, da Silva C, Nhacolo A, Arnaldo P, Salvador C, Cassy A, Candrinho B, Dimene M, Carvalho E, Saifodine A, Wate F, Mucavele H, Torres-Mendoza Y, Horton B, Plucinski M, Cistero P, Mayor A, Aide P. Efficacy of artemether-lumefantrine, artesunate-amodiaquine, dihydroartemisinin-piperaquine and artesunate-pyronaridine for the treatment of uncomplicated Plasmodium falciparum malaria in Mozambique, 2022. Malar J. 2025 Jul 14;24(1):231. doi: 10.1186/s12936-025-05473-9.
PubMed 40660279
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring the Therapeutic Efficacy of the Combinations Artemether-Lumefantrine, Amodiaquine-Artesunate, Dihydroartemisinin-Piperaquine, and Pironaridine-Artesunate in the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Under 5 Years of Age in Five Sentinel Sites in Mozambique
- ClinicalTrials.gov ID
- NCT05343312
- Acronym / sponsor ID
- MEFI_IV / 20/CNBS/22
- Conditions
- Malaria
- Keywords
- Treatment, Artemisine-based combinations, children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 870 participants (actual)
- Lead sponsor
- Centro de Investigacao em Saude de ManhicaUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 25 Apr 2022 (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 5 sites of the four oral ACTS artemether-lumefantrine (AL), Amodiaquine-Artesunate (AQ-AS), Dihydroartemisinin-Piperaquine (DHP) and Pironaridine-Artesunate for the treatment of uncomplicated malaria in children aged<5 years.
Detailed description
Eligible patients were consecutively assigned to the cohort and treated with AL (cohort 1), AQ-AS (cohort 2), DHP (cohort 3) and PA (cohort 4). 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. AQ-AS (Winthrop™) will be administered once daily according to body weight: one 25mg artesunate and 67.5mg amodiaquine tablet in children <9kg, one 50mg artesunate and 135mg amodiaquine tablet in children 9-17.9kg; and one 100mg artesunate and 270mg amodiaquine tablet in children >18-35kg. DHP will be administered once daily according to body weight: half tablet (40mg dihydroartemisinin e 320 mg piperaquine) for children 5 to < 10Kg, one tablet for per dose for those 10 < 20Kg and 2 tablets for 20 or more Kg. PA (granules 60mg pirinaridine +/20mg artesunate) will administered once daily according to body weight: 1 granule per dose for children 5 to < 8Kg, two for children 8 < 15Kg, three for those 15 < 20Kg. PA (180mg pyrinaridine+60 mg artesunate) one tablet for children 20 < 24Kg and two tablets for those 24 < 45Kg. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Artemether-Lumefantrine (AL) | Active comparator | Drug: AL (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. |
| Amodiaquine-Artesunate (AS-AQ) | Active comparator | Drug: AS-AQ (Carsucam)AQ-AS (Coarsucam™) will be administered once daily according to body weight: one 25mg artesunate and 67.5mg amodiaquine tablet in children <9kg, one 50mg artesunate and 135mg amodiaquine tablet in children 9-17.9kg; and one 100mg artesunate and 270mg amodiaquine tablet in children >18-35kg. |
| Dihydroartimisin+Piperaquine (DHP) | Active comparator | Drug: DHPDHP will be administered once daily according to body weight: tablet (40 mg dihydroartimisin+artesunate) half in children 5 < 10kg, one in children 10 < 20kg and 2 tablets for those children over 20 kg. |
| Pyronaridine +Artesunate (PA) | Active comparator | Drug: PAPA will be administered once daily according to body weight: granule ( 60 mg pyronaridine + 20 artesunate), one in children 5 < 7kg, two in children 8 < 15kg and three in children 15 < 20kg. Tablets ( 180 mg pyronaridine+ 60 mg artesunate), one in children 20 < 24Kg and two in children 24 < 45Kg. |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Ages 6 to 59 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 2,000 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 |
|---|---|---|
| AL (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. The Molecular markers associated with suboptimal response to ACTs will be investigated. | Drug | Artemether-Lumefantrine (AL) |
| AS-AQ (Carsucam)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, 28, 35 and 42 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, and 28 day of treatment failure or at any other unscheduled visit. The Molecular markers associated with suboptimal response to ACTs will be investigated. | Drug | Amodiaquine-Artesunate (AS-AQ) |
| DHPEligible 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, 28, 35 and 42 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. The Molecular markers associated with suboptimal response to ACTs will be investigated. | Drug | Dihydroartimisin+Piperaquine (DHP) |
| PAEligible 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, 28, 35 and 42 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. The Molecular markers associated with suboptimal response to ACTs will be investigated. | Drug | Pyronaridine +Artesunate (PA) |
Primary outcome
To measure the Day 28, PCR corrected cure rates of artemether-lumefantrine and Amodiaquine-artesunate.
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).
To measure the Day 42, PCR corrected cure rates of Dihydroartemisinin-Piperaquine and Pironaridine-Artesunate
Time frame: 42 days
This cure rate is defined as the proportion of patients with adequate clinical and parasitological response (ACPR) at Day 42, 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).
3 secondary outcomes
To evaluate the incidence of adverse events
Time frame: 28/42 days
To measure the Day PCR uncorrected cure rates of Artemether-Lumefantrine, Amodiaquine-Artesunate, Dihydroartemisinin-Piperaquine, and Pironaridine-Artesunate.
Time frame: 28/42 days
Evaluate the presence of Molecular Markers associated with sub optimum responses to ACTs
Time frame: 28/42 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 27 Aug 2025.
- Derived from this study: PubMed 40660279Nhama A, Chidimatembue A, Nhamussua L, Bassat Q, da Silva C, Nhacolo A, Arnaldo P, Salvador C, Cassy A, Candrinho B, Dimene M, Carvalho E, Saifodine A, Wate F, Mucavele H, Torres-Mendoza Y, Horton B, Plucinski M, Cistero P, Mayor A, Aide P. Efficacy of artemether-lumefantrine, artesunate-amodiaquine, dihydroartemisinin-piperaquine and artesunate-pyronaridine for the treatment of uncomplicated Plasmodium falciparum malaria in Mozambique, 2022. Malar J. 2025 Jul 14;24(1):231. doi: 10.1186/s12936-025-05473-9.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AL (Coartem), AS-AQ (Carsucam) and DHP in people with Malaria, run by Centro de Investigacao em Saude de Manhica at 5 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 27 Aug 2025. 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 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.
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 measure the Day 28, PCR corrected cure rates of artemether-lumefantrine and Amodiaquine-artesunate. (time frame: 28 days). The study lists 2 primary outcomes in all. 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 NCT05343312, 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 27 Aug 2025.