Last updated: March 25, 2024
Sponsor: University of Oxford
Overall Status: Active - Recruiting
Phase
3
Condition
N/ATreatment
Artemether-lumefantrine+ Amodiaquine (AL+AQ)
Artesunate-mefloquine+piperaquine (AS-MQ+PPQ)
Artesunate-mefloquine+placebo (AS-MQ+PBO)
Clinical Study ID
NCT03923725
MAL18004
Ages 6-12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female, aged ≥6 months to <12 years (For Gambia, Rwanda sites only: ≥6 months)
- Ability to take oral medication
- Acute uncomplicated P. falciparum monoinfection
- Asexual P. falciparum parasitaemia: 1,000/µL to ≤10% parasitaemia, determined on aperipheral blood film (At Gambia, Rwanda sites only: For subjects ≥12 years - 1000/µLto 200,000/µL)
- Fever defined as ≥ 37.5°C tympanic temperature or a history of fever within the last 24 hours
- Written informed consent by the subject or by parent/guardian in case of childrenlower than the age of consent and assent if required (per local regulations)
- Willingness and ability of the subjects or parents/guardians to comply with the studyprotocol for the duration of the study
Exclusion
Exclusion Criteria:
- Signs of severe malaria (adapted from WHO criteria)
- Patients not fulfilling criteria for severe malaria but with another indication forparenteral antimalarial treatment at the discretion of the treating physician
- Haematocrit <15% at screening (For Gambia, Rwanda sites only: For subjects ≥12 years -Haematocrit <20% at screening)
- Subjects who have received artemisinin or a derivative within the previous 7 days ORlumefantrine or amodiaquine within the previous 14 days OR mefloquine or piperaquinewithin the previous 30 days
- In applicable countries: use of seasonal malaria chemoprophylaxis (SMC) within thelast 14 days.
- Acute illness other than malaria requiring systemic treatment
- Severe acute malnutrition (in Niger only - only those patients with Severe AcuteMalnutrition and complications requiring inpatient nutritional treatment will beexcluded)
- Known HIV infection
- Known tuberculosis infection
- For females: post-menarche (For Gambia, Rwanda sites only: females who are pregnant,trying to get pregnant or are lactating)
- History of allergy or known contraindication to any of the study drugs, includingneuropsychiatric disorders and epilepsy
- Previous splenectomy
- Enrolment in DeTACT in the previous 3 months
- Participation in another interventional study in the previous 3 months
Study Design
Total Participants: 3240
Treatment Group(s): 4
Primary Treatment: Artemether-lumefantrine+ Amodiaquine (AL+AQ)
Phase: 3
Study Start date:
September 01, 2020
Estimated Completion Date:
September 30, 2024
Study Description
Connect with a study center
Institut des Sciences et Techniques (INSTech)
Bobo-Dioulasso 01,
Burkina FasoActive - Recruiting
Kinshasa School of Public Health
Kinshasa, BP 11850 Kin
Congo, The Democratic Republic of theActive - Recruiting
MRC Unit The Gambia at LSHTM
Fajara, Banjul 273
GambiaActive - Recruiting
Centre National de Formation et de Recherche en Santé Rurale de Mafèrinyah
Conakry, B.P. 2649
GuineaActive - Recruiting
Epicentre Niger
Niamey, BP: 13 330
NigerActive - Recruiting
Centre for Malaria and Other Tropical Diseases (CEMTROD)
Ilorin, Kwara State 1459
NigeriaActive - Recruiting
College of Medicine and Health Sciences, University of Rwanda
Kigali,
RwandaActive - Recruiting
National Institute For Medical Research (NIMR), Tanga Medical Research Centre
Tanga,
TanzaniaActive - Recruiting
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