PICOS | Characteristic criteria for inclusion |
---|---|
P: population | The study population were P. vivax mono-infected clinical malaria patients (all age groups) seeking medication at health facilities in Ethiopia, who fulfilled the inclusion criteria set by WHO for anti-malarial drug efficacy testing |
I: Intervention/exposure | Studies included in the current review followed any one or more of the following intervention strategies: fixed dose of CQ given for 3 consecutive days (2:2:1 ratio each day with a target total dose of 25Â mg/kg, alone or combined with 0.25Â mg/kg of PQ for 14Â days); or AL (20Â mg of artemether and 120Â mg of lumefantrine based on body weight, alone or combined with 0.25Â mg/kg of PQ for 14Â days); all anti-malarial drugs were orally administered (fully or partially supervised), and patients followed for a minimum of 28Â days |
C: comparison/ control | Any placebo or anti-malarial drugs other than CQ, such as PQ and AL or different combination treatments |
O: outcomes | Primary outcomes: parasitological and clinical efficacy of anti-malarial drugs, PCR-corrected or uncorrected late parasite recurrence or plasma drug level measured Major treatment outcomes [33] were: Treatment failure (TF): Early treatment failure (ETF): any danger signs or severe malaria on days 1, 2 or 3 in the presence of parasitaemia; or parasitaemia on day 2 higher than on day 0, irrespective of axillary temperature; or parasitaemia on day 3 with axillary temperature ≥ 37.5ºC; or parasitaemia on day 3 ≥ 25% of count on day 0 Late clinical failure (LCF): danger signs or severe malaria in the presence of parasitaemia on any day between days 4 and 28 or 42 in patients who did not previously meet any of the criteria of ETF; or presence of parasitaemia on any day between days 4 and 28 or 42 with axillary temperature ≥ 37.5ºC; or history of fever in patients who did not previously meet any of the criteria of ETF Late parasitological failure (LPF): presence of parasitaemia on any day between days 7 and 28 or 42 with axillary temperature < 37.5ºC in patients who did not previously meet any of the criteria of ETF or LCF Adequate clinical and parasitological response (ACPR): if there was no parasitaemia on the follow-up days (28 or 42) irrespective of axillary temperature in patients without ETF, LCF or LPF. This is considered treatment success In addition, if the level of drug (CQ-DCQ) on day of recurrence is ≥ 100 ηg/ml (above minimum effective concentration (MEC)), the reappeared parasites were considered resistant to CQ, irrespective of genotype (relapse, recrudescence or re-infection) and classified as CQ-resistant P. vivax [34] |
S: Studies | a.Randomized controlled trials (RCTs), non-randomized single-arm interventional studies (with or without a control group) and prospective cohort studies which enrolled all age groups, symptomatic patients with confirmed diagnosis of P. vivax mono-infection malaria, and who were followed-up for at least 28Â days post-treatment b.Studies that assessed the efficacy of a fixed dose of CQ as a single arm, or randomized into different loose combinations of CQ plus PQ, and AL plus PQ |