Malaria Infections and Infestations Malaria
Conditions
Interventions
All patients recruited into the study will be given full, supervised treatment with either:
1. Artesunate-mefloquine (ASMQ) co-formulation (25/55 mg), administered orally for 3 consecutive days accor
Sponsors
Drugs for Neglected Diseases initiative (DNDi) (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 6 to 59 months, either sex 2. Presence of acute uncomplicated P. falciparum mono-infection confirmed by: 2.1. Axillary temperature greater than 37.5°C, and 2.2. Positive microscopy of P. falciparum with parasite density between 2,000 and 200,000 asexual parasites/µl 3. Written informed consent from parent/guardian
Exclusion criteria
Exclusion criteria: 1. Patients with signs and symptoms of severe/complicated malaria requiring parenteral treatment according to the World Health Organization Criteria 2000 2. Weight less than 5 kg 3. Inability to tolerate oral medication (presence of any of the following danger signs: unable to drink or breastfeed, severe vomiting, recent history of convulsions, lethargic or unconscious state, unable to sit or stand up) 4. Mixed Plasmodium infection 5. Presence of febrile conditions caused by diseases other than malaria 6. Known history of hypersensitivity, allergic or serious adverse reactions to mefloquine, quinine, quinidine, artesunate or other artemisinins 7. History of use of any anti-malarial agent within 2 weeks prior to start of the study (except mefloquine and piperaquine within 4 weeks) 8. Prior participation in a therapeutic trial within 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cure rate as determined by polymer chain reaction (PCR)-corrected adequate clinical and parasitological response (ACPR) on Day 63. Treatment success or failures will be classified according to WHO Guidelines 2003. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety, measured on day 0, 1, 2, 3, 4, 7, 14, 21, 28, 35, 42, 49, 56, 63: 1.1. Frequency of adverse events by intervention 1.2. Detailed description of time course and vomiting frequency 1.3. Frequency of serious adverse events and adverse events leading to treatment discontinuation by intervention 2. Pharmacokinetics: population pharmacokinetic parameters for artesunate (AS), its main metabolite, dihydroartemisinin (DHA), mefloquine (MQ) and lumefantrine in a sub-set of 50 randomly selected patients. Drug levels for MQ and lumefantrine will be obtained for all patients on day 0 and day 7 and correlated with clinical response. Measured on day 0, 2, 3, 7, 28, 35, 42, 49, 56, 63. Furthermore, for all patients with recurrence of parasitemia, a blood sample will be collected on the day of failure, in order to know the drug level at that specific time point. | — |
Countries
Burkina Faso, Kenya, Tanzania
Outcome results
None listed