As aq

Tests were performed to determine the ability of the screening technologies to distinguish between products presented in different strengths as reflected by API content. For this evaluation, the following authentic samples were used: AS-AQ (50/135 mg)(Sanofi, Maphar, Morocco), AS-AQ (100/270 mg)(Sanofi, Maphar, Morocco), AR-LU (20/120 mg)(Ipca Laboratories Ltd., India), AR-LU (40/240 mg) (Ipca Laboratories Ltd., India).
CD3+, GPHF Minilab, and TruScan analyses of the AS-AQ (50/135 mg) “sample” were performed using the higher strength product—AS-AQ (100/270 mg)—as the reference product. Results from the tools indicating whether or not the sample was consistent with the reference product were documented. These analyses were repeated, the second time using the higher strength product as “sample” and the lower strength product as “reference.” The two AR-LU samples were similarly analysed using the three technologies.

AS-AQ (IPCA, India) was administered according to three weight groups (6.0–8.9 kg: 25 mg AS + 67.5mg AQ; 9.0–17.9 kg: 50 mg AS + 135 mg AQ; >17.9 kg: 100 mg AS + 270 mg AQ). 2 mg MB mini-tablets (Pharbil Waltrop GmbH, Germany) were administered once daily (together with AS-AQ) at a daily dose of 15 mg/kg for 3 days (days 0–2), and according to four weight groups (6.0–8.9 kg: 100 mg; 9.0–12.9 kg: 150 mg; 13.0–16.9 kg: 200 mg; >16.9 kg: 250 mg). Depending on the age of the study children, tablets were dissolved or crushed and administered with water. MB was given on a spoon with local food (e. g. banana, honey). PQ tablets (Sanofi, India) were administered at the last day of AS-AQ treatment (day 2). Tablets were dissolved in water and given with a plastic cup or spoon, followed by a cup of orange juice, according to four weight groups (6.0–8.9 kg: 2 mg PQ; 9.0–12.9 kg: 3 mg PQ; 13.0–16.9 kg: 4 mg PQ; >16.9 kg: 5 mg PQ). All treatments were directly observed. Full treatment was re-administered once if vomiting occurred within half an hour of treatment.
Children with an axillary temperature ≥ 38.5°C received standard doses of paracetamol (10 mg/kg every 6 hours) until fever subsided. Study children developing severe malaria during the trial were admitted to the Nouna Hospital and treated with artesunate intravenously according to national guidelines.

Children were treated with either AL (Cipla, Mumbai, India) or ASAQ (Sanofi-Aventis, Maphar, Morocco) for 3 days. The dosage was weight based according to the manufacturers’ recommendations. All ASAQ doses were directly observed by study staff and were administered with water or juice. For AL, morning doses were observed by study staff and were administered with yogurt or milk. Parents or guardians were given the evening dose and a yogurt or milk packet to give at home. Study staff telephoned parents or guardians in the evening to remind them to administer the evening dose, and compliance was further assessed by requesting parents or guardians to bring empty blister packets to the clinic the following day.
Children were monitored daily for the first 4 days and then weekly thereafter for a total of 28 days. At each visit, study staff performed clinical exams, performed blood smears (except for day 1), and collected blood on Whatman 903 filter paper (GE Healthcare Life Sciences, Marlborough, MA, USA). Hemoglobin was assessed fortnightly using HemoCue Hb301 (Hemocue, Ängelholm, Sweden) or DiaSpect (EKF Diagnostics, Barleben, Germany) hemoglobinometers.