Plasmodium FalciparumPhase 4NCT06300970
Efficacy of Artesunate-amodiaquine and Artemether-lumefantrine for Treatment of Plasmodium Falciparum Malaria in Liberia
A Phase 4 study testing Amodiaquine-artesunate (ASAQ) and Artemether+Lumefantrine (AL) in people with Plasmodium Falciparum and Malaria, run by Centers for Disease Control and Prevention at 2 sites in Liberia.
Trial summary
To assess the efficacy of both first-line antimalarial medications used for the treatment of uncomplicated Plasmodium falciparum malaria infections in two geographic regions in Liberia. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Plasmodium Falciparum, Malaria, Uncomplicated Malaria
- What is being tested?
- Amodiaquine-artesunate (ASAQ) and Artemether+Lumefantrine (AL)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 2 sitesLiberia
- Study dates
- 9 Aug 2022to 16 Aug 2023
- 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 to 59 months (5 years)
- Weight ≥ 5 kg
- Monoinfection with P. falciparum with a parasite density of 2,000 to 200,000 asexual forms per microliter of blood
- Axillary temperature ≥37.5˚C or history of fever in the last 24 hours
- Hemoglobin ≥ 8.0g/dl
- Easy access to the health facility and ability to return to the health facility over the course of the four weeks of follow-up
- Informed consent of parent or guardian
Who cannot join
- Any danger signs or signs of severe malaria (see Appendix I)
- Pneumonia or bronchopneumonia
- Severe malnutrition (Z-score < 3)
- History of taking antimalarials (or antibiotics with antimalarial activity such as cotrimoxazole, tetracycline or doxycycline) in the last 14 days
- Mixed malaria infection
- History of hypersensitivity or allergy to the medication
Trial locations and contacts
2 sites in 1 country.
Liberia2 sites
Saclepea-Mahn Comprehensive Health Center Saclepea-Mahn District, Nimba County
Saclepea, Nimba
Sinje Health Center, Garwula District, Sinje, Grand Cape Mount County
Sinje, Grand Cape Mount County
About this study
Official title: Efficacy of Artesunate-amodiaquine (ASAQ) and Artemether-lumefantrine (AL) for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Liberia
To assess the efficacy of both first-line antimalarial medications used for the treatment of uncomplicated Plasmodium falciparum malaria infections in two geographic regions in Liberia.
Read the detailed description
Title: Efficacy of artesunate+amodiaquine (ASAQ) and artemether+lumefantrine (AL) for the treatment of uncomplicated Plasmodium falciparum malaria in Liberia
Objective: To assess the efficacy of both first-line ASAQ and AL for the treatment of uncomplicated P. falciparum malaria infections
Study Sites: Sacleapea Comprehensive Health Center, Saclepea-Mah District in Nimba County; and Sinje Health Center, Garwula District, Sinje, in Grand Cape Mount County
Study Period: August 2022 to August 2023
Study Design: Prospective study of two cohorts with simultaneous enrolment of each therapy
Patient population: Patients aged 6 to 59 months with confirmed uncomplicated P. falciparum infection
Sample Size: Total number of patients to be enrolled is 352 patients. This consists of 88 patients per arm per site. There are two arms in each of the two sites.
Treatment(s) and follow-up: Patients enrolled in the ASAQ arm will receive the treatment once daily dose for three days. Patients enrolled in the AL arm will receive treatment twice daily dose for three days. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug 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 will be recorded.
Exploratory endpoints: Any polymorphisms of molecular markers for antimalarial drug resistance and prevalence of HRP2 deletions.
- Conditions
- Plasmodium Falciparum, Malaria, Uncomplicated Malaria
- Being tested
- Amodiaquine-artesunate (ASAQ), Artemether+Lumefantrine (AL)
- Keywords
- Plasmodium falciparum, Anti-malarial therapeutic efficacy study (TES), Artemisinin-based combination therapies (ACT)
- Medical subject headings
- Malaria, Falciparum, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amodiaquine-artesunate (ASAQ)Drug
Also called ASAQ, Camoquin
Oral medication given for treatment of uncomplicated plasmodium falciparum infection.
Artemether+Lumefantrine (AL)Drug
Also called AL, Coartem
Oral medication given for treatment of uncomplicated plasmodium falciparum infection.
| Study group | Role | What they receive |
|---|---|---|
| Artesunate+Amodiaquine (ASAQ) | Active comparator | Amodiaquine-artesunate (ASAQ) dose based on weight, given once daily for three days.
ASAQ has three formulations, with the dose depending on the weight of the child according to the following.
4.5-8.9 kg = 1 tablet 25 mg AS/67.5 mg AQ 9-17.9kg = 1 tablet 50 mg AS/135 mg AQ 18.0-35.9kg = 1 tablet 100 mg AS/270 mg AQ
≥36.0kg = 2 tablets 100 mg AS/270 mg AQ Receives: Drug: Amodiaquine-artesunate (ASAQ) |
| Artemether+Lumefantrine (AL) | Active comparator | Artemether+Lumefantrine (AL) dose is based on weight and given twice daily for three days. AL has one formulation, with pills containing 20 mg artemether and 120 mg lumefantrine. The number of tablets per dose depends on the weight of the child according to the following:
5 -14.9 kg = 1 tablet per dose 15 -24.9 kg = 2 tablets per dose 25 -34.9 kg = 3 tablets per dose
≥35 kg = 4 tablets per dose
1 tablet contains 20 mg artemether and 120 mg lumefantrine Receives: Drug: Artemether+Lumefantrine (AL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Early Treatment Failure (ETF)
- Danger signs or severe malaria on day 1, 2, or 3 in the presence of parasitemia
- A parasitemia on day 2 higher than day 0
- Axillary temperature ≥ 37.5 °C on day 3 in the presence of parasitemia
- Parasitemia on day 3 ≥ 25% of day 0 parasitemia
Measured: Day 1 to day 3 following treatment.
Number of Participants with Late Treatment Failure (LTF)
- Danger signs, signs of severe malaria, or axillary temperature > 37.5 °C in the presence of parasitemia on any day between day 4 and day 28 in patients who did not previously meet any of the criteria of early treatment failure
- Presence of parasitemia (with a parasite with the same genotype as day 0) on any day between day 7 and day 28 regardless of temperature in patients who did not previously meet any of the criteria of early treatment failure
Measured: Day 4 to day 28 following treatment.
Number of Participants with Adequate Clinical and Parasitological Response (APCR)
- Absence of parasitemia on day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure, late clinical failure, reinfection or late parasitological failure.
Measured: Day 28 following treatment.
Secondary outcomes (1)
Number of Patients with 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 during participation in the study, approximately 4 weeks.
Measured: During participation in the study, approximately 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start9 Aug 2022
- Primary completion16 Aug 2023
- Study completion16 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasmodium FalciparumStudies 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
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Ministry of Health, Liberia
- Responsible party
- Principal investigator, Jonathan Schultz, Centers for Disease Control and Prevention
- Investigators
- Victor S Koko, Principal investigator, Liberia National Malaria Control Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300970
- Sponsor's protocol ID
- 0900f3eb81e634a9
- Status last verified
- May 2024
- First submitted
- 13 Feb 2024
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD should be requested from the Liberian Ministry of Health
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Artesunate-amodiaquine (ASAQ) and Artemether-lumefantrine (AL) for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Liberia
- ClinicalTrials.gov ID
- NCT06300970
- Acronym / sponsor ID
- 0900f3eb81e634a9
- Conditions
- Plasmodium Falciparum, Malaria, Uncomplicated Malaria
- Keywords
- Plasmodium falciparum, Anti-malarial therapeutic efficacy study (TES), Artemisinin-based combination therapies (ACT)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Ministry of Health, Liberia
- Study start
- 9 Aug 2022 (actual)
- Primary completion
- 16 Aug 2023 (actual)
- Study completion
- 16 Aug 2023 (actual)
- First posted
- 8 Mar 2024 (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.
To assess the efficacy of both first-line antimalarial medications used for the treatment of uncomplicated Plasmodium falciparum malaria infections in two geographic regions in Liberia.
Detailed description
Title: Efficacy of artesunate+amodiaquine (ASAQ) and artemether+lumefantrine (AL) for the treatment of uncomplicated Plasmodium falciparum malaria in Liberia
Objective: To assess the efficacy of both first-line ASAQ and AL for the treatment of uncomplicated P. falciparum malaria infections
Study Sites: Sacleapea Comprehensive Health Center, Saclepea-Mah District in Nimba County; and Sinje Health Center, Garwula District, Sinje, in Grand Cape Mount County
Study Period: August 2022 to August 2023
Study Design: Prospective study of two cohorts with simultaneous enrolment of each therapy
Patient population: Patients aged 6 to 59 months with confirmed uncomplicated P. falciparum infection
Sample Size: Total number of patients to be enrolled is 352 patients. This consists of 88 patients per arm per site. There are two arms in each of the two sites.
Treatment(s) and follow-up: Patients enrolled in the ASAQ arm will receive the treatment once daily dose for three days. Patients enrolled in the AL arm will receive treatment twice daily dose for three days. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug 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 will be recorded.
Exploratory endpoints: Any polymorphisms of molecular markers for antimalarial drug resistance and prevalence of HRP2 deletions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Artesunate+Amodiaquine (ASAQ) | Active comparator | Drug: Amodiaquine-artesunate (ASAQ)Amodiaquine-artesunate (ASAQ) dose based on weight, given once daily for three days. ASAQ has three formulations, with the dose depending on the weight of the child according to the following. 4.5-8.9 kg = 1 tablet 25 mg AS/67.5 mg AQ 9-17.9kg = 1 tablet 50 mg AS/135 mg AQ 18.0-35.9kg = 1 tablet 100 mg AS/270 mg AQ ≥36.0kg = 2 tablets 100 mg AS/270 mg AQ |
| Artemether+Lumefantrine (AL) | Active comparator | Drug: Artemether+Lumefantrine (AL)Artemether+Lumefantrine (AL) dose is based on weight and given twice daily for three days. AL has one formulation, with pills containing 20 mg artemether and 120 mg lumefantrine. The number of tablets per dose depends on the weight of the child according to the following: 5 -14.9 kg = 1 tablet per dose 15 -24.9 kg = 2 tablets per dose 25 -34.9 kg = 3 tablets per dose ≥35 kg = 4 tablets per dose 1 tablet contains 20 mg artemether and 120 mg lumefantrine |
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 to 59 months (5 years)
- Weight ≥ 5 kg
- Monoinfection with P. falciparum with a parasite density of 2,000 to 200,000 asexual forms per microliter of blood
- Axillary temperature ≥37.5˚C or history of fever in the last 24 hours
- Hemoglobin ≥ 8.0g/dl
Key exclusion criteria (6 listed)
- Any danger signs or signs of severe malaria (see Appendix I)
- Pneumonia or bronchopneumonia
- Severe malnutrition (Z-score < 3)
- History of taking antimalarials (or antibiotics with antimalarial activity such as cotrimoxazole, tetracycline or doxycycline) in the last 14 days
- Mixed malaria infection
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 |
|---|---|---|
| Amodiaquine-artesunate (ASAQ)Also: ASAQ, CamoquinOral medication given for treatment of uncomplicated plasmodium falciparum infection. | Drug | Artesunate+Amodiaquine (ASAQ) |
| Artemether+Lumefantrine (AL)Also: AL, CoartemOral medication given for treatment of uncomplicated plasmodium falciparum infection. | Drug | Artemether+Lumefantrine (AL) |
Primary outcome
Number of Participants with Early Treatment Failure (ETF)
Time frame: Day 1 to day 3 following treatment.
* Danger signs or severe malaria on day 1, 2, or 3 in the presence of parasitemia * A parasitemia on day 2 higher than day 0 * Axillary temperature ≥ 37.5 °C on day 3 in the presence of parasitemia * Parasitemia on day 3 ≥ 25% of day 0 parasitemia
Number of Participants with Late Treatment Failure (LTF)
Time frame: Day 4 to day 28 following treatment.
* Danger signs, signs of severe malaria, or axillary temperature > 37.5 °C in the presence of parasitemia on any day between day 4 and day 28 in patients who did not previously meet any of the criteria of early treatment failure * Presence of parasitemia (with a parasite with the same genotype as day 0) on any day between day 7 and day 28 regardless of temperature in patients who did not previously meet any of the criteria of early treatment failure
Number of Participants with Adequate Clinical and Parasitological Response (APCR)
Time frame: Day 28 following treatment.
• Absence of parasitemia on day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure, late clinical failure, reinfection or late parasitological failure.
1 secondary outcome
Number of Patients with Adverse Events
Time frame: During participation in the study, approximately 4 weeks.
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 7 May 2024.
- Individual participant dataSharing planned: Yes. IPD should be requested from the Liberian Ministry of Health
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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.
Victor S Koko principal investigator
Liberia National Malaria Control Program
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 Amodiaquine-artesunate (ASAQ) and Artemether+Lumefantrine (AL) in people with Plasmodium Falciparum and Malaria, run by Centers for Disease Control and Prevention at 2 sites in Liberia.
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 6 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 7 May 2024. 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 Liberia. 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 Participants with Early Treatment Failure (ETF) (time frame: Day 1 to day 3 following treatment.). The study lists 3 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 7 May 2024.