Uncomplicated MalariaPhase 4Kenya-TESNCT04767191
Malaria Therapeutic Efficacy Study (TES) Kenya
A Phase 4 study testing artemether lumefantrine and dihydroartemisinin piperaquine in people with Uncomplicated Malaria, run by Jhpiego at 2 sites in Kenya.
Trial summary
WHO recommends that Therapeutic Efficacy Studies (TES) for 1st and 2nd line antimalarial medicines should be routinely carried out and data made available for decision-making due to the threat of emergence and spread of artemisinin resistance in malaria-endemic countries, especially in Africa. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Uncomplicated Malaria
- What is being tested?
- artemether lumefantrine and dihydroartemisinin piperaquine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesKenya
- Study dates
- 15 Mar 2021to 18 Dec 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
- age between 6 months to 59 months; mono-infection with P. falciparum confirmed by positive blood smear (i.e. no mixed infection);
- parasitaemia of 1,000 - 100,000/µl asexual forms;
- presence of axillary temperature ≥ 37.5 °C or history of fever during the past 24 h;
- ability to swallow oral medication;
- haemoglobin ≥5.0 g/dL at admission;
- informed consent from a parent or guardian;
- parent/guardian agrees to bring the patient for planned follow-up visits at day 7, 14, 21, and 28
Who cannot join
- general danger signs or signs of severe falciparum malaria according to the definitions of WHO;
- severe malnutrition according to WHO child growth standards (WHO, 2006), children with marasmus or oedematous malnutrition;
- mixed or mono-infection with another Plasmodium species detected by microscopy;
- presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea 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);
- history of receiving any antimalarial treatment in the preceding 72 hours;. exposure to malaria vaccine
Trial locations and contacts
2 sites in 1 country.
Kenya2 sites
Makhonge Health Centre
Bungoma, Bungoma County
Kaluo Health Centre
Siaya, Siaya County
About this study
Official title: Efficacy of Artemether Lumefantrine (AL) and Dihydroartemisinin-Piperaquine (DHP) for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Siaya and Bungoma Counties, Kenya
WHO recommends that Therapeutic Efficacy Studies (TES) for 1st and 2nd line antimalarial medicines should be routinely carried out and data made available for decision-making due to the threat of emergence and spread of artemisinin resistance in malaria-endemic countries, especially in Africa. In line with this WHO recommendation, Kenya Ministry of Health (MOH) is conducting the TES to determine the efficacy of artemether lumefantrine (AL), and dihydroartemisinin-piperaquine (DHP), the first and second line treatment of uncomplicated malaria in Kenya. The objective of this study is to inform the decisions or actions made by a public health authority (Kenya Ministry of Health) to inform decision on revision of the antimalarial guidelines and policy in Kenya. Jhpiego's Impact Malaria project in Kenya, with funding and technical oversight from US President's Malaria Initiative (PMI) through USAID and CDC, will support the Kenya MOH in its effort to evaluate the efficacy of AL and DHP in the treatment of children with uncomplicated malaria. The study is being conducted by Kenya MOH, with technical support and funding by PMI-USAID through Jhpiego in Kenya.
Read the detailed description
WHO recommends that Therapeutic Efficacy Studies (TES) for 1st and 2nd line antimalarial medicines should be routinely carried out and data made available for decision-making due to the threat of emergence and spread of artemisinin resistance in malaria-endemic countries, especially in Africa. In its strategy to strengthen malaria surveillance, Kenya's Ministry of Health (MOH) National Malaria Program (NMP) planned to conduct TES every three years to ascertain continuing efficacy of the first and second-line treatments. The last TES for 1st line treatment of malaria in Kenya was done in Siaya county in 2016. In line with the WHO recommendation, Jhpiego Impact Malaria project in Kenya, with funding and technical oversight from Center for Disease Prevention and Control (CDC) will be supporting the Kenya MOH NMP to conduct a TES to assess the efficacy of the current first and second line treatment policy in Kenya. The study is being conducted by Kenya MOH NMP, with technical oversight and funding by CDC through the Jhpiego Impact Malaria project in Kenya.
Objective: To assess the efficacy of Artemether Lumefantrine (AL) and Dihydroartemisinin-Piperaquine (DHP) for the treatment of uncomplicated P. falciparum malaria infections.
Study Sites: One site will be selected in Siaya county and one site will be selected in Bungoma county (Kimilili Sub-County). Both sites will be Level-2 facilities (health centers) with high outpatient department attendance of patients with malaria. At each site, there will be two study arms: one arm for AL and one arm for DHP.
Study Period: March 2021 to September 2021
Study Design: This surveillance study is a two-arm prospective study Patient population: Febrile patients aged between 6 months and 59 months, with confirmed uncomplicated P. falciparum monoinfection.
Sample Size: At each site, at least 100 patients will be enrolled per drug (200 patients per site, 400 patients total).
Treatment(s) and follow-up: Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate AL efficacy, and over a 42-day follow-up period to evaluate DHP efficacy.
Primary endpoints: The proportion of patients with early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response as indicators of efficacy. Recrudescence will be distinguished from re-infection by polymerase chain reaction (PCR) analysis.
Secondary endpoints: The frequency and nature of adverse events.
Exploratory endpoints: to determine the polymorphism of molecular markers of drug resistance and evasion of diagnostic testing; to determine the blood concentration of AL
- Conditions
- Uncomplicated Malaria
- Being tested
- artemether lumefantrine, dihydroartemisinin piperaquine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
artemether lumefantrineDrug
The drugs are approved and in use by the Kenya Ministry of Health as the 1st and 2nd line treatment for malaria. The study is to assess the continued efficacy of the two drugs in the treatment of uncomplicated malaria.
dihydroartemisinin piperaquineDrug
Antimalarial Combinations
| Study group | Role | What they receive |
|---|---|---|
| artemether lumefantrine | Active comparator | The drug is approved and in use by the Kenya Ministry of Health as the 1st line treatment for malaria. The study is to assess the continued efficacy of the drug. Receives: Drug: artemether lumefantrine |
| dihydroartemisinin piperaquine | Active comparator | The drug is approved and in use by the Kenya Ministry of Health as the 2nd line treatment for malaria. The study is to assess the continued efficacy of the drug. Receives: Drug: dihydroartemisinin piperaquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients (in the Artemether Lumefantrine arm) with clinical and parasitological cure (i.e. free of malaria symptoms and parasites) assessed clinically and via microscopy and rapid diagnostic test.
Measured: By day 28 post-treatment
Number of patients (in the Dihydroartemisinin-Piperaquine arm) with clinical and parasitological cure (i.e. free of malaria symptoms and parasites) assessed clinically and via microscopy and rapid diagnostic test.
Measured: By day 42 post-treatment
Secondary outcomes (4)
Number of patients (in the Artemether Lumefantrine arm arm) with treatment-related adverse events
Measured: by day 28 post-treatment
Number of patients (in the Dihydroartemisinin-Piperaquine arm) with treatment-related adverse events
Measured: by day 42 post-treatment
Number of patients (in the Artemether Lumefantrine arm) with molecular markers of drug resistance assessed via phenotype test
Measured: by day 28 post-treatment
Number of patients (in the Dihydroartemisinin-Piperaquine arm) with molecular markers of drug resistance assessed via phenotype test
Measured: by day 42 post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start15 Mar 2021
- Primary completion18 Dec 2022
- Study completion18 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncomplicated 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
- The two drugs being assessed are already approved and in use by the Kenya Ministry of Health as the 1st and 2nd line treatments for malaria. The study is to assess the continued efficacy of the drugs.
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jhpiego
- Sponsor type
- University, hospital or other
- Collaborators
- Kenya Ministry of Health, Centers for Disease Control and Prevention, United States Agency for International Development (USAID)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767191
- Sponsor's protocol ID
- IRB00012257
- Acronym
- Kenya-TES
- Status last verified
- Oct 2023
- First submitted
- 11 Feb 2021
- Last updated
- 1 Nov 2023
- 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 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Artemether Lumefantrine (AL) and Dihydroartemisinin-Piperaquine (DHP) for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Siaya and Bungoma Counties, Kenya
- ClinicalTrials.gov ID
- NCT04767191
- Acronym / sponsor ID
- Kenya-TES / IRB00012257
- Conditions
- Uncomplicated Malaria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- JhpiegoUniversity, hospital or other
- Collaborators
- Kenya Ministry of Health, Centers for Disease Control and Prevention, United States Agency for International Development (USAID)
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 18 Dec 2022 (actual)
- Study completion
- 18 Dec 2022 (actual)
- First posted
- 23 Feb 2021 (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.
WHO recommends that Therapeutic Efficacy Studies (TES) for 1st and 2nd line antimalarial medicines should be routinely carried out and data made available for decision-making due to the threat of emergence and spread of artemisinin resistance in malaria-endemic countries, especially in Africa. In line with this WHO recommendation, Kenya Ministry of Health (MOH) is conducting the TES to determine the efficacy of artemether lumefantrine (AL), and dihydroartemisinin-piperaquine (DHP), the first and second line treatment of uncomplicated malaria in Kenya. The objective of this study is to inform the decisions or actions made by a public health authority (Kenya Ministry of Health) to inform decision on revision of the antimalarial guidelines and policy in Kenya. Jhpiego's Impact Malaria project in Kenya, with funding and technical oversight from US President's Malaria Initiative (PMI) through USAID and CDC, will support the Kenya MOH in its effort to evaluate the efficacy of AL and DHP in the treatment of children with uncomplicated malaria. The study is being conducted by Kenya MOH, with technical support and funding by PMI-USAID through Jhpiego in Kenya.
Detailed description
WHO recommends that Therapeutic Efficacy Studies (TES) for 1st and 2nd line antimalarial medicines should be routinely carried out and data made available for decision-making due to the threat of emergence and spread of artemisinin resistance in malaria-endemic countries, especially in Africa. In its strategy to strengthen malaria surveillance, Kenya's Ministry of Health (MOH) National Malaria Program (NMP) planned to conduct TES every three years to ascertain continuing efficacy of the first and second-line treatments. The last TES for 1st line treatment of malaria in Kenya was done in Siaya county in 2016. In line with the WHO recommendation, Jhpiego Impact Malaria project in Kenya, with funding and technical oversight from Center for Disease Prevention and Control (CDC) will be supporting the Kenya MOH NMP to conduct a TES to assess the efficacy of the current first and second line treatment policy in Kenya. The study is being conducted by Kenya MOH NMP, with technical oversight and funding by CDC through the Jhpiego Impact Malaria project in Kenya.
Objective: To assess the efficacy of Artemether Lumefantrine (AL) and Dihydroartemisinin-Piperaquine (DHP) for the treatment of uncomplicated P. falciparum malaria infections.
Study Sites: One site will be selected in Siaya county and one site will be selected in Bungoma county (Kimilili Sub-County). Both sites will be Level-2 facilities (health centers) with high outpatient department attendance of patients with malaria. At each site, there will be two study arms: one arm for AL and one arm for DHP.
Study Period: March 2021 to September 2021
Study Design: This surveillance study is a two-arm prospective study Patient population: Febrile patients aged between 6 months and 59 months, with confirmed uncomplicated P. falciparum monoinfection.
Sample Size: At each site, at least 100 patients will be enrolled per drug (200 patients per site, 400 patients total).
Treatment(s) and follow-up: Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate AL efficacy, and over a 42-day follow-up period to evaluate DHP efficacy.
Primary endpoints: The proportion of patients with early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response as indicators of efficacy. Recrudescence will be distinguished from re-infection by polymerase chain reaction (PCR) analysis.
Secondary endpoints: The frequency and nature of adverse events.
Exploratory endpoints: to determine the polymorphism of molecular markers of drug resistance and evasion of diagnostic testing; to determine the blood concentration of AL
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The two drugs being assessed are already approved and in use by the Kenya Ministry of Health as the 1st and 2nd line treatments for malaria. The study is to assess the continued efficacy of the drugs.
| Arm | Type | Receives |
|---|---|---|
| artemether lumefantrine | Active comparator | Drug: artemether lumefantrineThe drug is approved and in use by the Kenya Ministry of Health as the 1st line treatment for malaria. The study is to assess the continued efficacy of the drug. |
| dihydroartemisinin piperaquine | Active comparator | Drug: dihydroartemisinin piperaquineThe drug is approved and in use by the Kenya Ministry of Health as the 2nd line treatment for malaria. The study is to assess the continued efficacy of the drug. |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- age between 6 months to 59 months; mono-infection with P. falciparum confirmed by positive blood smear (i.e. no mixed infection);
- parasitaemia of 1,000 - 100,000/µl asexual forms;
- presence of axillary temperature ≥ 37.5 °C or history of fever during the past 24 h;
- ability to swallow oral medication;
- haemoglobin ≥5.0 g/dL at admission;
Key exclusion criteria (7 listed)
- general danger signs or signs of severe falciparum malaria according to the definitions of WHO;
- severe malnutrition according to WHO child growth standards (WHO, 2006), children with marasmus or oedematous malnutrition;
- mixed or mono-infection with another Plasmodium species detected by microscopy;
- presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea 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;
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 lumefantrineThe drugs are approved and in use by the Kenya Ministry of Health as the 1st and 2nd line treatment for malaria. The study is to assess the continued efficacy of the two drugs in the treatment of uncomplicated malaria. | Drug | artemether lumefantrine |
| dihydroartemisinin piperaquineAntimalarial Combinations | Drug | dihydroartemisinin piperaquine |
Primary outcome
Number of patients (in the Artemether Lumefantrine arm) with clinical and parasitological cure (i.e. free of malaria symptoms and parasites) assessed clinically and via microscopy and rapid diagnostic test.
Time frame: By day 28 post-treatment
Number of patients (in the Dihydroartemisinin-Piperaquine arm) with clinical and parasitological cure (i.e. free of malaria symptoms and parasites) assessed clinically and via microscopy and rapid diagnostic test.
Time frame: By day 42 post-treatment
4 secondary outcomes
Number of patients (in the Artemether Lumefantrine arm arm) with treatment-related adverse events
Time frame: by day 28 post-treatment
Number of patients (in the Dihydroartemisinin-Piperaquine arm) with treatment-related adverse events
Time frame: by day 42 post-treatment
Number of patients (in the Artemether Lumefantrine arm) with molecular markers of drug resistance assessed via phenotype test
Time frame: by day 28 post-treatment
Number of patients (in the Dihydroartemisinin-Piperaquine arm) with molecular markers of drug resistance assessed via phenotype test
Time frame: by day 42 post-treatment
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 1 Nov 2023.
- 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.
2 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 artemether lumefantrine and dihydroartemisinin piperaquine in people with Uncomplicated Malaria, run by Jhpiego at 2 sites in Kenya.
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 7 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 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kenya. 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?
Number of patients (in the Artemether Lumefantrine arm) with clinical and parasitological cure (i.e. free of malaria symptoms and parasites) assessed clinically and via microscopy and rapid diagnostic test. (time frame: By day 28 post-treatment). 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?
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 1 Nov 2023.