MalariaPhase 4TETRDC2016NCT02940756
Efficacy and Safety of Artemisinin-based Combination Treatments in the Democratic Republic of the Congo
A Phase 4 study testing artesunate-amodiaquine, artemether-lumefantrine and Dihydroartemisinine-piperaquine 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
The Democratic Republic of the Congo (DRC) is among the countries most affected by malaria in Sub-Saharan Africa. Condidering its size and the geographic position, the DRC is meant to play a major role in the malaria control in the region. 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, artemether-lumefantrine and Dihydroartemisinine-piperaquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,615 participants
- Where
- 6 sitesDemocratic Republic of the Congo
- Study dates
- 15 Mar 2017to 2 Jan 2018
- 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
- axillary temperature ≥ 37.5 °C or history of fever during the 24 h before recruitment
- monoinfection with Plasmodium falciparum with asexual parasite count of 2,000 to 200,000/µL
- 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/guardian
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- absence of general danger signs or signs of severe falciparum malaria according to the definitions of WHO (2000)
- absence of severe malnutrition according to WHO child growth standards
- absence of febrile condition 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 or hepatic diseases, HIV/AIDS)
- absence of regular medication, which might interfere with antimalarial pharmacokinetics
- absence of history of hypersensitivity reactions or contraindication to any medicine being tested or used as alternative treatment
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
- mixed or monoinfection with another Plasmodium species detected by microscopy
- 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;
- history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Democratic Republic of the Congo6 sites
Centre de santé Bolenge
Bolenge, Équateur Province
Centre de Santé Foyer Social
Kabondo, Tshopo
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 de Référence Rutshuru
Rutshuru, North Kivu
About this study
Official title: Efficacy and Safety of Artesunate-amodiaquine, Artemether-lumefantrine and Dihydroartemisinine-piperaquine in the Treatment of Uncomplicated Plasmodium Falciparum Malaria in the Democratic Republic of Congo: a Randomized Controlled Trial
The Democratic Republic of the Congo (DRC) is among the countries most affected by malaria in Sub-Saharan Africa. Condidering its size and the geographic position, the DRC is meant to play a major role in the malaria control in the region. 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, in order to ascertain the relevance of treatment guidelines such that, 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®), artemether-lumefantrine (Coartem Dispersible®) and dihydro-artemisinin-piperaquine (Eurartesim®) at day 42 in the treatment of uncomplicated Plasmodium falciparum malaria in six surveillance sites around DRC.
Read the detailed description
This is a phase 4, randomized, open labelled clinical trial, aiming to assess efficacy and safety of 3 ACTs in the treatment of uncomplicated malaria in the Democratic Republic of the Congo. Children diagnosed with uncomplicated Plasmodium falciparum uncomplicated malaria will be randomized and followed-up during 42 days.
- Conditions
- Malaria
- Being tested
- artesunate-amodiaquine, artemether-lumefantrine, Dihydroartemisinine-piperaquine
- Keywords
- Malaria, efficacy, safety, ACT, DR Congo
- 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 artesunate-amodiaquine Winthrop®
Tablets containing 25 mg of artesunate and 67.5 mg of amodiaquine: one tablet daily for three days 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-lumefantrineDrug
Also called Coartem®
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.
Dihydroartemisinine-piperaquineDrug
Also called Eurartesim®
Tablets containing 20 mg of dihydroartemisinine and 160 mg of piperaquine. Half a tablet once daily for children weighing 5 to <7 kg, one tablet once daily for those weighing 7 to <13 kg, and two tablets once daily for those weighing 13 to <24 kg, for three days.
| 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 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 |
| Dihydroartemisinine-piperaquine | Experimental | Tablets containing 20 mg of dihydroartemisinine and 160 mg of piperaquine. Half a tablet once daily for children weighing 5 to <7 kg, one tablet once daily for those weighing 7 to <13 kg, and two tablets once daily for those weighing 13 to <24 kg, for three days. Receives: Drug: Dihydroartemisinine-piperaquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCR-adjusted efficacy
the proportion of children with PCR adequate clinical and parasitological response
Measured: day 42
Secondary outcomes (3)
PCR-unadjusted efficacy
the proportion of children with treatment failure: all treatment failures detected during the follow-up, regardless of genotyping
Measured: day 42
K-13 propeller polymorphisms
the proportion of mutations in portions of P. falciparum gene encoding kelch(K-13)-propeller domains (confering resistance to artemisinin)
Measured: day 42
incidence of adverse events
monitoring of all adverse events experienced by participants
Measured: day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study start15 Mar 2017
- Primary completion2 Jan 2018
- Study completion2 Jan 2018
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
- 1,615 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Public Health, Democratic Republic of the Congo
- Sponsor type
- Other government
- 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
- NCT02940756
- Sponsor's protocol ID
- ASAQ-LA-DHAPQP 2015 DRC
- Acronym
- TETRDC2016
- Status last verified
- Nov 2017
- First submitted
- 19 Oct 2016
- Last updated
- 3 Jan 2018
- 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 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Artesunate-amodiaquine, Artemether-lumefantrine and Dihydroartemisinine-piperaquine in the Treatment of Uncomplicated Plasmodium Falciparum Malaria in the Democratic Republic of Congo: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02940756
- Acronym / sponsor ID
- TETRDC2016 / ASAQ-LA-DHAPQP 2015 DRC
- Conditions
- Malaria
- Keywords
- Malaria, efficacy, safety, ACT, DR Congo
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,615 participants (actual)
- Lead sponsor
- Ministry of Public Health, Democratic Republic of the CongoOther government
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 2 Jan 2018 (actual)
- Study completion
- 2 Jan 2018 (actual)
- First posted
- 21 Oct 2016 (estimated)
- 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.
The Democratic Republic of the Congo (DRC) is among the countries most affected by malaria in Sub-Saharan Africa. Condidering its size and the geographic position, the DRC is meant to play a major role in the malaria control in the region. 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, in order to ascertain the relevance of treatment guidelines such that, 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®), artemether-lumefantrine (Coartem Dispersible®) and dihydro-artemisinin-piperaquine (Eurartesim®) at day 42 in the treatment of uncomplicated Plasmodium falciparum malaria in six surveillance sites around DRC.
Detailed description
This is a phase 4, randomized, open labelled clinical trial, aiming to assess efficacy and safety of 3 ACTs in the treatment of uncomplicated malaria in the Democratic Republic of the Congo. Children diagnosed with uncomplicated Plasmodium falciparum uncomplicated malaria will be randomized and followed-up during 42 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| 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 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. |
| Dihydroartemisinine-piperaquine | Experimental | Drug: Dihydroartemisinine-piperaquineTablets containing 20 mg of dihydroartemisinine and 160 mg of piperaquine. Half a tablet once daily for children weighing 5 to <7 kg, one tablet once daily for those weighing 7 to <13 kg, and two tablets once daily for those weighing 13 to <24 kg, for three days. |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- children aged 6 to 59 months
- axillary temperature ≥ 37.5 °C or history of fever during the 24 h before recruitment
- monoinfection with Plasmodium falciparum with asexual parasite count of 2,000 to 200,000/µL
- 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
- mixed or monoinfection with another Plasmodium species detected by microscopy
- presence of severe malnutrition
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: artesunate-amodiaquine Winthrop®Tablets containing 25 mg of artesunate and 67.5 mg of amodiaquine: one tablet daily for three days 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. | Drug | artesunate-amodiaquine |
| artemether-lumefantrineAlso: Coartem®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. | Drug | artemether-lumefantrine |
| Dihydroartemisinine-piperaquineAlso: Eurartesim®Tablets containing 20 mg of dihydroartemisinine and 160 mg of piperaquine. Half a tablet once daily for children weighing 5 to <7 kg, one tablet once daily for those weighing 7 to <13 kg, and two tablets once daily for those weighing 13 to <24 kg, for three days. | Drug | Dihydroartemisinine-piperaquine |
Primary outcome
PCR-adjusted efficacy
Time frame: day 42
the proportion of children with PCR adequate clinical and parasitological response
3 secondary outcomes
PCR-unadjusted efficacy
Time frame: day 42
K-13 propeller polymorphisms
Time frame: day 42
incidence of adverse events
Time frame: day 42
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 3 Jan 2018.
- 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.
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, artemether-lumefantrine and Dihydroartemisinine-piperaquine 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 11 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 3 Jan 2018. 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: day 42). 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 3 Jan 2018.