Treatment Efficacy and Malaria TRANSmission After Artemisinin Combination Therapy 2 (TRANSACT2) (TRANSACT2)
Malaria
About this trial
This is an interventional treatment trial for Malaria focused on measuring Malaria treatment efficacy, Malaria transmission
Eligibility Criteria
Inclusion Criteria:
- Age 6 months - 10 years
- Residents of research area (5 km around the clinic)
- Willingness to come for complete scheduled follow-up.
- Uncomplicated malaria with P. falciparum mono-infection
- Parasitaemia of 1000-200,000 parasites/ul
- Temperature > 37.5°C and < 39.5°C, or history of fever in previous 24 hours.
- No history of adverse reactions to AL
- Understanding of the procedures of the study by parent or guardian and willing to participate by signing informed consent forms.
Exclusion Criteria:
- General signs of severe malaria
- Haemoglobin concentration < 5g/dl
- Presence of disease other than malaria causing febrile conditions
- Mixed infection with P. malariae or other non-falciparum malaria species
- Unwilling to participate and sign informed consent forms.
Sites / Locations
- St. Jude's Clinic, ICIPE Thomas Odhiambo Campus
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Artemether- Lumefantrine
Drug: Mefloquine-Artesunate, an alternative ACT
Treatment with artemether-lumefantrine (AL; Coartem; Novartis Pharma), administered as half a tablet (20 mg of artemether and 120 mg of lumefantrine) per 5 kg of body weight in a 6-dose regimen (at enrolment and 8, 20, 32, 44, and 56 h [+/-90 min] after the initiation of treatment). AL is currently the first line treatment in Tanzania Other Name: Coartem;
Treatment with the paediatric fixed dose combination Mefloquine-Artesunate (MQ-AS; Artequin; Mepha, Aesch, Basel, Switzerland, artesunate (50 mg/day) and mefloquine (125 mg/day) fixed dose formulation (stick pack) once daily for 3 consecutive days, given in three daily doses. The weight range of enrolled children is chosen to be recommended for this fixed dose combination. MQ-AS is available in Kenya as Artequin and has been extensively tested in uncomplicated malaria in children.