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New treatment option for Uncomplicated Plasmodium Falciparum Malaria
Official title A Study to Find Out if a Combination of 3 Medicines for the Treatment of Malaria Works as Well and is as Safe and Tolerable as Combinations of 2 Medicines
ClinicalTrials.gov ID: NCT05951595
What this study is testing
What is Artemether-Lumefantrine-Amodiaquine (ALAQ)?
Artemether-Lumefantrine-Amodiaquine (ALAQ) is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for uncomplicated plasmodium falciparum malaria.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this open-label randomised, controlled, non-inferiority trial is to assess and compare the efficacy, tolerability and safety of a fixed dose TACT artemether-lumefantrine-amodiaquine (ALAQ) to the ACTs artemether-lumefantrine (AL), artesunate-amodiaquine (ASAQ) (with single low-dose primaquine in some sites) for the treatment of uncomplicated Plasmodium falciparum malaria in patient. The main question it aims to answer is whether ALAQ, a fixed dose TACT, is as efficacious, safe and tolerable in comparison with AL and ASAQ.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 and older
You may be able to join if
- Male or female, aged ≥6 months (no upper limit unless one is required by local regulations) and bodyweight ≥5 kg
- Ability to take oral medication
- Fever defined as ≥38°C tympanic temperature or a history of fever within the last 24 hours
- Acute uncomplicated P. falciparum monoinfection
- Asexual P. falciparum parasitaemia: 1,000/µL to 250,000/µL determined on a peripheral blood film
You likely can't join if
- Signs of severe malaria (adapted from WHO criteria)
- Patients not fulfilling criteria for severe malaria but with other indication(s) for parenteral antimalarial treatment at the discretion of the...
- Haemoglobin \<7 g/dL at screening
- Participants who have received artemisinin or a derivative within the previous 7 days OR lumefantrine or amodiaquine within the previous 14 days
- In applicable countries: use of seasonal malaria chemoprophylaxis (SMC) within the last 30 days
- Acute illness other than malaria requiring systemic treatment
See the full eligibility criteria
- Male or female, aged ≥6 months (no upper limit unless one is required by local regulations) and bodyweight ≥5 kg
- Ability to take oral medication
- Fever defined as ≥38°C tympanic temperature or a history of fever within the last 24 hours
- Acute uncomplicated P. falciparum monoinfection
- Asexual P. falciparum parasitaemia: 1,000/µL to 250,000/µL determined on a peripheral blood film
- Written informed consent by the participant, or by the parent/guardian in case of children lower than the age of consent, and assent if required (per local regulations)
- Willingness and ability of the participants or parents/guardians to comply with the study protocol for the duration of the study
- Signs of severe malaria (adapted from WHO criteria)
- Patients not fulfilling criteria for severe malaria but with other indication(s) for parenteral antimalarial treatment at the discretion of the treating physician
- Haemoglobin \<7 g/dL at screening
- Participants who have received artemisinin or a derivative within the previous 7 days OR lumefantrine or amodiaquine within the previous 14 days
- In applicable countries: use of seasonal malaria chemoprophylaxis (SMC) within the last 30 days
- Acute illness other than malaria requiring systemic treatment
- Severe acute malnutrition
- Known HIV, tuberculosis, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or other severe infection
- For women of child-bearing age: pregnant, trying to get pregnant or lactating
- History of allergy or known contraindication to any of the study drugs, including neuropsychiatric disorders and epilepsy
- Previous splenectomy
- Participation in the previous 3 months and/or ongoing follow-up for an treatment study (including FD-TACT)
The study team makes the final eligibility decision.
Where it's taking place
- Ruhuha, Eastern Province, Rwanda
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ruhuha, Eastern Province, Rwanda. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.