Uncomplicated Plasmodium Falciparum MalariaPhase 4TES2022NCT06076213
Test Efficacy Study on the Recommended Antimalarial Drugs in the Democratic Republic of the Congo
A Phase 4 study testing Artesunate-amodiaquine and Artemether-lumefantrine in people with Uncomplicated Plasmodium Falciparum Malaria, run by Ministry of Public Health, Democratic Republic of the Congo at 7 sites in Democratic Republic of the Congo.
Trial summary
Malaria remains a public health concern, despite efforts that are invested in the disease control. The Democratic Republic of the Congo (DRC) is one of the most affected countries in Sub Saharan Africa. Artemisinin-based combination treatments (ACTs) are recommended for the treatment of uncomplicated malaria. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Uncomplicated Plasmodium Falciparum Malaria
- What is being tested?
- Artesunate-amodiaquine and Artemether-lumefantrine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,260 participants
- Where
- 7 sitesDemocratic Republic of the Congo
- Study dates
- 1 May 2023to 30 Sep 2024
- 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 6 to 59 months
- monoinfection with Plasmodium falciparum with asexual parasite count of 2,000 to 200,000/µL
- axillary temperature ≥ 37.5 °C
- ability to swallow oral medication
- ability and willingness to comply with the protocol for the duration of the study and to comply with the study visit schedule;
- informed consent from a parent or a guardian
Show all 10Show fewer
- living within the study catchment area
- absence of severe manutrition
- absence of infectious diseases that can be responsible of fever
- absence of allergy to the study drugs
Who cannot join
- presence of general danger signs or signs of severe falciparum malaria according to the definitions of WHO;
- body weight < 5kg
- hemoglobin level < 5g/ dL or hematocrit < 15%
- presence of severe malnutrition
- presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
- regular medication, which may interfere with antimalarial pharmacokinetics;
Show all 9Show fewer
- malaria treatment within 2 days prior to recruitment
- history of hypersensitivity reactions or contraindications to any of the medicines being tested or used as alternative treatment;
- body weight below 5 kg
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Democratic Republic of the Congo7 sites
Centre de santé Boende 2 Nsele
Boende, Tshuapa
Centres de santé Umoja et Foyer social
Kabondo, Tshopo
Centre de santé de Kalima
Kalima, Maniema Province
Centre de santé Lupidi 1
Kapolowe, Haut-Katanga
Centres de santé de Mikalayi et Matamba
Kazumba, Kasai-Central
Centre de santé de Coopération
Kimpese, Bas-Congo Province
Centre de Santé de Vanga
Vanga, Kwilu
About this study
Official title: Efficacy and Safety of Artesunate-amodiaquine and Artemether-lumefantrine in the Treatment of Uncomplicated Plasmodium Falciparum Malaria in the Democratic Republic of the Congo: a Randomized Controlled Trial (TES2022)
Malaria remains a public health concern, despite efforts that are invested in the disease control. The Democratic Republic of the Congo (DRC) is one of the most affected countries in Sub Saharan Africa. Artemisinin-based combination treatments (ACTs) are recommended for the treatment of uncomplicated malaria. However, reported cases of mutations that confer to Plasmodium falciparum resistance to artemisinin (the main component of ACTs) constitute a threat to malaria control, particularly in Sub Saharan Africa. Therefore, the recommendation of the World Health Organization to conduct regularly test efficacy studies in endemic countries is paramount.
The purpose of this trial is to assess efficacy and safety of artesunate-amodiaquine (ASAQ Winthrop®) and artemether-lumefantrine (Coartem Dispersible®) at day 28 for the treatment of uncomplicated Plasmodium falciparum malaria in eight surveillance sites around DRC.
Read the detailed description
This is a phase IV, randomized, open label, 2-arm trial. It will be performed in eight malaria sentinel sites around DRC. Children aged 6 to 59 months with confirmed Plasmodium falciparum uncomplicated malaria will be enrolled after informed consent granted by a parent or guardian. They will be randomized to receive either artesunate-amodiaquine or artemether lumefrantrine during 3 days (directly observed treatment) and then followed up until day 28. At each visit, clinical examination (including collection of safety data) will be done and malaria testing as well. Dried blood spots will also be prepared whenever microscopy is performed, in order to assess resistance markers and perform the genotyping of the parasite for PCR-adjusted efficacy. Hemoglobin level will be measured on the recruitment day and then every two weeks until day 28.
- Being tested
- Artesunate-amodiaquine, Artemether-lumefantrine
- Keywords
- Uncomplicated malaria, Plasmodium falciparum, Artemisinin-based Combination Treatment, Artemether-lumefantrine, Artesunate-amodiaquine
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artesunate-amodiaquineDrug
Also called ASAQ Winthrop®
Tablets
Artemether-lumefantrineDrug
Also called Coartem Dispersible®
Tablets
| Study group | Role | What they receive |
|---|---|---|
| Artesunate-amodiaquine | Experimental | tablets of ASAQ Winthrop® Receives: Drug: Artesunate-amodiaquine |
| Artemether-lumefantrine | Experimental | tablets of Coartem Dispersible® Receives: Drug: Artemether-lumefantrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCR adjusted efficacy
Absence of fever and negative blood smear during the follow-up until day 28 or new infection occurred during the follow-up.
Measured: day 28
Secondary outcomes (4)
Proportion of adverse events and serious adverse events
Number of adverse events and serious adverse events that every participant will experience
Measured: day 28
Prevalence of HRP2 deletion
Proportion of positive samples that fail to be detected by malaria rapid diagnostic tests due to the deletion of the related antigen
Measured: Baseline
Prevalence of resistance markers at baseline
Proportion of samples containing different markers of resistance to different antimalarial drugs
Measured: Baseline
Quantification of Lumefantrine
Level of lumefantrine in the blood of children who will be randomized to the Artemether-lumefantrine arm
Measured: day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 May 2023
- Primary completion24 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncomplicated Plasmodium Falciparum 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization 1:1 in two treatment arms: artesunate-amodiaquine and artemether-lumefantrine
- Masking
- None (open label)
- Enrolment
- 1,260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Public Health, Democratic Republic of the Congo
- Sponsor type
- Other government
- Collaborators
- Centers for Disease Control and Prevention, Global Fund
- Responsible party
- Principal investigator, Prof. Gauthier Mesia Kahunu, Ministry of Public Health, Democratic Republic of the Congo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076213
- Sponsor's protocol ID
- ASAQ-AL 2022
- Acronym
- TES2022
- Status last verified
- Nov 2024
- First submitted
- 24 Sep 2023
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Artesunate-amodiaquine and Artemether-lumefantrine in the Treatment of Uncomplicated Plasmodium Falciparum Malaria in the Democratic Republic of the Congo: a Randomized Controlled Trial (TES2022)
- ClinicalTrials.gov ID
- NCT06076213
- Acronym / sponsor ID
- TES2022 / ASAQ-AL 2022
- Keywords
- Uncomplicated malaria, Plasmodium falciparum, Artemisinin-based Combination Treatment, Artemether-lumefantrine, Artesunate-amodiaquine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,260 participants (actual)
- Lead sponsor
- Ministry of Public Health, Democratic Republic of the CongoOther government
- Collaborators
- Centers for Disease Control and Prevention, Global Fund
- Study start
- 1 May 2023 (actual)
- Primary completion
- 24 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 10 Oct 2023 (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.
Malaria remains a public health concern, despite efforts that are invested in the disease control. The Democratic Republic of the Congo (DRC) is one of the most affected countries in Sub Saharan Africa. Artemisinin-based combination treatments (ACTs) are recommended for the treatment of uncomplicated malaria. However, reported cases of mutations that confer to Plasmodium falciparum resistance to artemisinin (the main component of ACTs) constitute a threat to malaria control, particularly in Sub Saharan Africa. Therefore, the recommendation of the World Health Organization to conduct regularly test efficacy studies in endemic countries is paramount.
The purpose of this trial is to assess efficacy and safety of artesunate-amodiaquine (ASAQ Winthrop®) and artemether-lumefantrine (Coartem Dispersible®) at day 28 for the treatment of uncomplicated Plasmodium falciparum malaria in eight surveillance sites around DRC.
Detailed description
This is a phase IV, randomized, open label, 2-arm trial. It will be performed in eight malaria sentinel sites around DRC. Children aged 6 to 59 months with confirmed Plasmodium falciparum uncomplicated malaria will be enrolled after informed consent granted by a parent or guardian. They will be randomized to receive either artesunate-amodiaquine or artemether lumefrantrine during 3 days (directly observed treatment) and then followed up until day 28. At each visit, clinical examination (including collection of safety data) will be done and malaria testing as well. Dried blood spots will also be prepared whenever microscopy is performed, in order to assess resistance markers and perform the genotyping of the parasite for PCR-adjusted efficacy. Hemoglobin level will be measured on the recruitment day and then every two weeks until day 28.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization 1:1 in two treatment arms: artesunate-amodiaquine and artemether-lumefantrine
| Arm | Type | Receives |
|---|---|---|
| Artesunate-amodiaquine | Experimental | Drug: Artesunate-amodiaquinetablets of ASAQ Winthrop® |
| Artemether-lumefantrine | Experimental | Drug: Artemether-lumefantrinetablets of Coartem Dispersible® |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- children aged 6 to 59 months
- monoinfection with Plasmodium falciparum with asexual parasite count of 2,000 to 200,000/µL
- axillary temperature ≥ 37.5 °C
- ability to swallow oral medication
- ability and willingness to comply with the protocol for the duration of the study and to comply with the study visit schedule;
Key exclusion criteria (9 listed)
- presence of general danger signs or signs of severe falciparum malaria according to the definitions of WHO;
- body weight < 5kg
- hemoglobin level < 5g/ dL or hematocrit < 15%
- presence of severe malnutrition
- presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
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 |
|---|---|---|
| Artesunate-amodiaquineAlso: ASAQ Winthrop®Tablets | Drug | Artesunate-amodiaquine |
| Artemether-lumefantrineAlso: Coartem Dispersible®Tablets | Drug | Artemether-lumefantrine |
Primary outcome
PCR adjusted efficacy
Time frame: day 28
Absence of fever and negative blood smear during the follow-up until day 28 or new infection occurred during the follow-up.
4 secondary outcomes
Proportion of adverse events and serious adverse events
Time frame: day 28
Prevalence of HRP2 deletion
Time frame: Baseline
Prevalence of resistance markers at baseline
Time frame: Baseline
Quantification of Lumefantrine
Time frame: day 7
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 5 Nov 2024.
Related trials for Uncomplicated Plasmodium Falciparum Malaria
RecruitingPhase 2
Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort C2)
Uncomplicated Plasmodium Falciparum Malaria
Not yet recruitingObservational study
Ethiopian Antimalarial Therapeutic Efficacy Study 2026
Plasmodium Vivax Malaria Without Complication, Plasmodium Falciparum Malaria (Uncomplicated)
Not yet recruitingPhase 4
Study to Assess Safety and Clinical Responses With Coartem® Baby Dispersible Tablets in Paediatric Patients Weighing 2 to <5 kg With Uncomplicated Malaria
Malaria
Not yet recruitingPhase 2
A Phase 2A Study of a Novel Antimalarial Pyrrolidinamide in Adult Patients With Uncomplicated P. Falciparum Malaria
Malaria, Falciparum
RecruitingPhase 2
Safety and Efficacy of Imatinib in Combination With Artemether-Lumefantrine for Uncomplicated Malaria
Malaria (Plasmodium Falciparum)
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.
7 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 Artesunate-amodiaquine and Artemether-lumefantrine in people with Uncomplicated Plasmodium Falciparum Malaria, run by Ministry of Public Health, Democratic Republic of the Congo at 7 sites in Democratic Republic of the Congo.
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 10 inclusion and 9 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 5 Nov 2024. 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 Democratic Republic of the Congo. 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?
PCR adjusted efficacy (time frame: day 28). 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 5 Nov 2024.