Methods | Individually RCT | |
Participants | Number of participants: 214 (no dropouts mentioned) Gabon International Tropical Medicine Institute Age range: 6-60, All have P. falciparum malaria clinical symptoms and blood smear positive. 1. Trial group: 108, male 50, female 58, age 16.4 +/-10.5 2. Control group: 106, male 52, female 54, age 18.2 +/- 9.4 Exclusion criteria: N/A | |
Interventions | 1. Artesunate IM injection, daily for 5 days, 1.2 mg/kg each dose, first dose double. PQ 3 tablets (base 7.5 mg/tablet, children use half) once a day, for 5 days. 2. Only artesunate IM injection daily for 5 days, 1.2 mg/kg each dose, the first dose double total 5 days. | |
Outcomes | 1. Fever clearance time: (hrs) below 37°C continuously measured four times 2. Clinical cure rate at day 7 3. Adverse events (not specified) 4. Recrudescence rate: symptoms appeared again after clinical cure; parasite appeared in blood smear by 28 days Follow-up: 28 days | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Stated to be randomized, and the fact that numbers per group are not equal supports this contention. |
Allocation concealment (selection bias) | Unclear risk | No information given. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not stated. |
Selective reporting (reporting bias) | Unclear risk | Not stated. |
Other bias | Unclear risk | Unknown. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not stated to be blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated to be blinded. |
AL = artemether-lumefantrine
AQ = amodiaquine
AS = artesunate
CQ = chloroquine
DHAP = dihydroartemisinin-piperaquine
G6PD = glucose-6-phosphate dehydrogenase
IM = Intramuscular
MQ = mefloquine
PCR = polymerase chain reaction
Pf = Plasmodium falciparum
PQ = primaquine
QN = quinine
RCT = randomized controlled trial
SP = sulfadoxine-pyrimethamine