MalariaPhase 4TET2020NCT04618523
Safety and Efficacy of Recommended Antimalarial in the Democratic Republic of the Congo
A Phase 4 study testing Artesunate-amodiaquine and Artemether-lumefantrine in people with Malaria, run by Ministry of Public Health, Democratic Republic of the Congo at 6 sites in Democratic Republic of the Congo.
Trial summary
Despite all efforts, malaria remains a public health concern, in particular in the Democratic Republic of the Congo (DRC). The National Malaria Control program recommends artemisinin-based combination treatments (ACTs), in particular artesunate-amodiaquine or artemether-lumefrantrine for the treatment of uncomplicated… Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- 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
- 1,117 participants
- Where
- 6 sitesDemocratic Republic of the Congo
- Study dates
- 26 Oct 2020to 8 Feb 2022
- 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 aguardian
- living within the study catchment area
Who cannot join
- presence of general danger signs in children aged under 5 years 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;
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Democratic Republic of the Congo6 sites
Centre de Santé Boende 2 Nsele
Boende, Tshuapa
Centre de Santé Lupidi 1
Kapolowe, Haut-Katanga
Centre de Santé de Référence Mikalayi
Kazumba, Kasai-Central
Centre Evangélique de Coopération
Kimpese, Bas-Congo Province
Centre de Santé Foyer Social
Kisangani, Tshopo
Centre de Santé de Référence Rutshuru
Rutshuru, North Kivu
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
Despite all efforts, malaria remains a public health concern, in particular in the Democratic Republic of the Congo (DRC). The National Malaria Control program recommends artemisinin-based combination treatments (ACTs), in particular artesunate-amodiaquine or artemether-lumefrantrine for the treatment of uncomplicated malaria. Previous studies indicated that ACTs are still effective, with efficacy above the required threshold of 90%. It is required to assess regularly the efficacy of antimalarial drugs. I In case of increasing failure rates, alternative options can be decided ontime.
The purpose of this trial is to assess efficacy and safety of artesunate-amodiaquine (ASAQ Winthrop®) and artemether-lumefantrine (Coartem Dispersible®) at day 28 in the treatment of uncomplicated Plasmodium falciparum malaria in six surveillance sites around DRC.
Read the detailed description
This is a phase IV, randomized, open label, 2-arm trial. It will be performed in six malaria sentinel site around the Democratic Republic of the Congo. 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 will be done and malaria testing as well. Hemoglobin level will be measured on recruitment day and then every two weeks until day 28.
- Conditions
- Malaria
- Being tested
- Artesunate-amodiaquine, Artemether-lumefantrine
- Medical subject headings
- Malaria
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®
Artemisinin-based combination treatment
Artemether-lumefantrineDrug
Also called Coartem dispersible®
Artemisinin-based combination treatment
| Study group | Role | What they receive |
|---|---|---|
| Artesunate-amodiaquine | Experimental | Tablets containing 25 mg of artesunate and 67.5 mg of amodiaquine: one tablet daily for three days for children weighing 4.5 to 8 kg, and tablets containing 50 mg of artesunate and 135 mg of amodiaquine: one tablet daily for three days for children weighing 9 to 17 kg. Receives: Drug: Artesunate-amodiaquine |
| Artemether-lumefantrine | Experimental | Tablets containing 20 mg of Artemether and 120 mg of Lumefantrine. Each dose to be taken with high-fat food or drinks (for example milk).
One tablet twice daily for children weighing 5 to <15 kg, two tablets twice daily for those weighing 15 to <25 kg and three tablets twice daily for those weighing 25 to < 35 kg, for three days. 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 and new infections occurred during the follow-up.
Measured: 28 days
Secondary outcomes (2)
Proportion of adverse events and serious adverse events
Number of adverse events and serious adverse events that every participant will experience
Measured: 28 days
Proportion of participants with positive blood smear at day 3
Number of participants who will still have parasites on day 3
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start26 Oct 2020
- Primary completion8 Feb 2022
- Study completion8 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Public Health, Democratic Republic of the Congo
- Sponsor type
- Other government
- Collaborators
- University of Kinshasa, World Health Organization, Institut National de Recherche Biomedicale (INRB)
- Responsible party
- Principal investigator, Prof. Gauthier Mesia Kahunu, Ministry of Public Health, Democratic Republic of the Congo
- Investigators
- Gauthier Mesia Kahunu, PhD, Principal investigator, University of Kinshasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618523
- Sponsor's protocol ID
- ASAQ-LA 2019 DRC
- Acronym
- TET2020
- Status last verified
- Feb 2022
- First submitted
- 22 Oct 2020
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. 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
- ClinicalTrials.gov ID
- NCT04618523
- Acronym / sponsor ID
- TET2020 / ASAQ-LA 2019 DRC
- Conditions
- Malaria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,117 participants (actual)
- Lead sponsor
- Ministry of Public Health, Democratic Republic of the CongoOther government
- Collaborators
- University of Kinshasa, World Health Organization, Institut National de Recherche Biomedicale (INRB)
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 8 Feb 2022 (actual)
- Study completion
- 8 Feb 2022 (actual)
- First posted
- 6 Nov 2020 (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.
Despite all efforts, malaria remains a public health concern, in particular in the Democratic Republic of the Congo (DRC). The National Malaria Control program recommends artemisinin-based combination treatments (ACTs), in particular artesunate-amodiaquine or artemether-lumefrantrine for the treatment of uncomplicated malaria. Previous studies indicated that ACTs are still effective, with efficacy above the required threshold of 90%. It is required to assess regularly the efficacy of antimalarial drugs. I In case of increasing failure rates, alternative options can be decided ontime.
The purpose of this trial is to assess efficacy and safety of artesunate-amodiaquine (ASAQ Winthrop®) and artemether-lumefantrine (Coartem Dispersible®) at day 28 in the treatment of uncomplicated Plasmodium falciparum malaria in six surveillance sites around DRC.
Detailed description
This is a phase IV, randomized, open label, 2-arm trial. It will be performed in six malaria sentinel site around the Democratic Republic of the Congo. 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 will be done and malaria testing as well. Hemoglobin level will be measured on 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
| Arm | Type | Receives |
|---|---|---|
| Artesunate-amodiaquine | Experimental | Drug: Artesunate-amodiaquineTablets containing 25 mg of artesunate and 67.5 mg of amodiaquine: one tablet daily for three days for children weighing 4.5 to 8 kg, and tablets containing 50 mg of artesunate and 135 mg of amodiaquine: one tablet daily for three days for children weighing 9 to 17 kg. |
| Artemether-lumefantrine | Experimental | Drug: Artemether-lumefantrineTablets containing 20 mg of Artemether and 120 mg of Lumefantrine. Each dose to be taken with high-fat food or drinks (for example milk). One tablet twice daily for children weighing 5 to <15 kg, two tablets twice daily for those weighing 15 to <25 kg and three tablets twice daily for those weighing 25 to < 35 kg, for three days. |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 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 (8 listed)
- presence of general danger signs in children aged under 5 years 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®Artemisinin-based combination treatment | Drug | Artesunate-amodiaquine |
| Artemether-lumefantrineAlso: Coartem dispersible®Artemisinin-based combination treatment | Drug | Artemether-lumefantrine |
Primary outcome
PCR adjusted efficacy
Time frame: 28 days
absence of fever and negative blood smear during the follow-up until day 28 and new infections occurred during the follow-up.
2 secondary outcomes
Proportion of adverse events and serious adverse events
Time frame: 28 days
Proportion of participants with positive blood smear at day 3
Time frame: 3 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 9 Feb 2022.
- 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.
Gauthier Mesia Kahunu, PhD principal investigator
University of Kinshasa
6 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 Malaria, run by Ministry of Public Health, Democratic Republic of the Congo at 6 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 7 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 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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: 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 9 Feb 2022.