Evaluation of recurrent malaria after treatment with artemisinin-based combination therapies of uncomplicated cases among children 10 years and younger in Ghana.

Evaluation of recurrent malaria after treating uncomplicated cases with artemether-lumefantrine or artesunate-pyronaridine among children 10 years and younger in Ghana.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

PACTR

Registry ID

PACTR202603660167879

Enrollment

700

Registered

2026-03-03

Start date

2024-01-01

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

Interventions

Artesunate pyronaridine arm

Artemether lumefantrine arm

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Children 6 months to 10 years (131 months) 2. Temperature of = 37.5 °C, or a history of fever reported by the caregiver within 48 hours prior to presentation at the hospital 3. Mono-infection with P. falciparum confirmed by light microscopy 4. Child can be treated with AL or AP 5. Children whose informed consent has been duly signed by a parent or guardian 6. Willingness and ability to comply with the study procedures for the duration of the study

Exclusion criteria

Exclusion criteria: 1. Weight under 5 kg 2. Haemoglobin level below 8 g/dL 3. Children suffering from severe malnutrition as defined by WHO standard growth charts. 4. Admission to ward 5. Presence of clinically diagnosed febrile conditions other than malaria (e.g. otitis media, pneumonia, meningitis, ear-nose-throat infections, measles, septicaemia, etc) 6. Known hypersensitivity and contraindications to AL or AP components

Design outcomes

Primary

Measure	Time frame
To measure Day 28 and Day 42 clinical and parasitological efficacy of AL and AP for treating uncomplicated malaria in children ten years and younger defined as PCR-corrected adequate clinical and parasitological response	—

Secondary

Measure	Time frame
To determine the prevalence of known antimalarial resistance markers i.e. pfk 13 C580Y, pfpm2/3, pfmdr1, pfcrt K76T and N86Y;To determine the blood concentration of the artemisinin partner drugs, lumefantrine and pyronaridine, at predose, day 3 and day 7 after drug administration ;To assess the incidence of adverse events after treatment with AL or AP ;To measure the ex vivo/in vitro susceptibility of clinical isolates of Plasmodium falciparum to a panel of antimalarial drugs	—

Measure

Time frame

To determine the prevalence of known antimalarial resistance markers i.e. pfk 13 C580Y, pfpm2/3, pfmdr1, pfcrt K76T and N86Y;To determine the blood concentration of the artemisinin partner drugs, lumefantrine and pyronaridine, at predose, day 3 and day 7 after drug administration ;To assess the incidence of adverse events after treatment with AL or AP ;To measure the ex vivo/in vitro susceptibility of clinical isolates of Plasmodium falciparum to a panel of antimalarial drugs

—

Countries

Ghana

Contacts

Public ContactEva Puorideme

Project Manager

e.puorideme@kccr.de+233554306651

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026