Malaria
Conditions
Interventions
AP plus SP
Artemether lumefantrine
Sponsors
CERMEL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Uncomplicated malaria (Plasmodia of any species) diagnosed as per national policies and in line with WHO recommendations: o Fever or history of fever in the previous 24 h and/or the presence of anaemia, for which pallor of the palms appears to be the most reliable sign in young children. o Confirmation of malaria by a parasitological diagnosis (RDT or Microscopy (thick blood smear)). • Weight =5 kg. • Ability to take an oral medication. • Ability and willingness to participate based on signed informed consent (a parent or a guardian has to sign for children below 18 years old), or on verbal consent given in front of a witness signing the informed consent, and access to health facility. The patient has to comply with all scheduled follow-up visits.
Exclusion criteria
Exclusion criteria: • Patients with clinical signs or symptoms of hepatic injury (such as nausea, abdominal pain associated with jaundice) or known severe liver disease (i.e. decompensated cirrhosis, Child-Pugh stage 3 or 4). • Known allergy to any of the study drugs. • Known pregnancy. • Lactating women should be excluded if other anti-malarial treatments are available. • Complicated malaria as per WHO 2012 definition (Annex 2). • Patients that the investigator considers would be at particular risk if receiving an anti-malarial or if participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Day 28 PCR-adjusted adequate clinical and parasitological response (ACPR) [intention to treat and per-protocol populations] | — |
Secondary
| Measure | Time frame |
|---|---|
| Main secondary evaluation criterion: Incidence of adverse events including serious adverse events and adverse events of special interest; ;Crude Day 28 cure rate by species and PCR adjusted cure rate for Day 28 cure rate for P. falciparum [intention to treat and per-protocol population];Recurrence, reinfection and recrudescence rate until day 28;Gametocyte carriage up to day 28 by microscopy.;Time between malaria episodes and frequency of repeat episodes before and after Day 28;Compliance of AL will be assessed by counting the number of tablets dispensed but not taken, when the CHW visits the patient at home;Safety (including hepatic safety) in retreated patients.;Haematology recovery, that is, haemoglobin changes between day 0 and day 28.;Time between malaria episodes and frequency of repeat episodes before and after Day 28 | — |
Countries
Gabon
Contacts
Public ContactGhyslain Mombo Ngoma
Head of Clinical Operations
Outcome results
None listed