Table 1 Summary of the methodology of assessing anti-malarial efficacy and its reporting
Name (references) | Design | Efficacy endpoint (day) | Malaria until delivery | Retreatment (previous drug) | Symptom | Supervision | PCR (molecular marker) for recurrence | Efficacy reported | Statistical method for summary | Correction by PCR |
|---|---|---|---|---|---|---|---|---|---|---|
Naing [36] | RCT | 7 | INA | Not excluded | Symptomatic | Hospitalized | No | Parasite clearance time | Mean | No PCR |
Harinasuta [37] | RCT | 7 | INA | No | INA | INA | No | Parasite clearance | Number | No PCR |
Nosten [23] | RCT | 28 | Not followed | Not excluded | Botha | Full | No | Failure | Proportion | No PCR |
Sowunmi [38] | RCT | 14 for AM 28 for AM-MQ | INA | Yes (CHQ/SP) | Symptomatic | Full | No | Cure | Proportion | No PCR |
Bounyasong [39] | RCT | 42 | Weekly | No | Symptomatic | Full | No recurrence | Failure | Number | No recurrence |
McGready [40] | RCT | Delivery or 63 | Weekly | Not excluded | Botha | Full | msp-1, msp-2, glurp | Cure | Cumulative success | Corrected only |
McGready [41] | RCT | 42 | Weekly | Not excluded | Botha | Full | msp-1, msp-2, glurp | Cure | Cumulative success | Corrected only |
McGready [42] | RCT | Delivery or 63 | Weekly | No | Botha | Full | msp-1, msp-2, glurp | Cure | Cumulative success | Corrected only |
Adam [43] | RCT | 28 | INA | Yes (CHQ) | Symptomatic | Full | msp-1, msp-2, glurp | Failure | Proportion | Corrected only |
Kalilani [44] | RCT | 28 | Interval not specified | No | Botha | Full | msp-1 | Failure | Proportion Survival analysis for comparison | Both corrected and uncorrected |
McGready [45] | RCT | Delivery or 42 | Weekly | 28% recrudescence (Q, AS, DP, ASMQ) | Botha | Full | msp-1, msp-2, glurp | Cure | Cumulative success | Corrected only |
Mutabingwa [46] | RCT | 28 | At delivery and 42Â days postpartum | No | Botha | Full | msp-2 | Failure | Proportion | Both corrected and uncorrected |
Kaye [47] | RCT | 28 | Not followed | No | Symptomatic | First dose | No late failure | Failure | Proportion | No late failure |
Piola [48] | RCT | Delivery or 42 | Weekly | Not excluded | Botha | Full | msp-1, msp-2, glurp | Cure &Â failure | Proportion Log-rank test for comparison | Both corrected and uncorrected |
Carmona-Fonseca [49] | RCT | 28 | Not followed | No | Symptomatic | INA | No recurrence | Cure | Proportion | No recurrence |
RCT | 63 | Only at delivery | No | Botha | Full | msp-1, msp-2, glurp | Cure | Proportion Survival analysis for comparison | Both corrected and uncorrected | |
Osarfo [52] | RCT | 42 | Only at delivery | No | Asymptomatic | First dose | msp-1, msp-2, glurp (Failed) | Cure | Proportion | Uncorrected only |
Onyamboko [53] | RCT | 42 | INA | No | INA | Full | INA | Cure | INA | Uncorrected only |
Ukah [54] | RCT | 28 | Not followed | No | Symptomatic | INA | No | Cure | Proportion Log-rank test for comparison | No PCR |
Iribhogbe [55] | RCT | 28 | Not followed | No | Symptomatic | INA | No | Failure | Proportion | No PCR |
CTRI/2009/091/001055 [56] | RCT | 63 | INA | No | Botha | INA | Yes | Cure &Â failure | INA | INA |
NCT01054248 [57] | RCT | Delivery or 63 | Weekly | Not excluded | Botha | Full | Yes | Cure | Cumulative success | Both corrected and uncorrected |
McGready [58] | PK study | Delivery or 42 | Weekly | Yes (Q) | Botha | Full | msp-1, msp-2, glurp | Cure | Proportion | No recurrence |
Adam [59] | PK study | 63 | Weekly (some) | No | INA | Full | Yes | Cure &Â failure | Number | Corrected only |
Onyamboko [60] | PK study | 28 | INA | No | Asymptomatic | Full | No | Failure | Number | No PCR |
McGready [61] | PK study | Delivery or 63 | Weekly | Not excluded | Botha | Full | msp-1, msp-2, glurp | Cure | Cumulative success | Both corrected and uncorrected |
Rijken [62] | PK study | Delivery or 63 | Weekly | Two pregnant or non-pregnant women were self-treated (CHQ) | Symptomatic | Full | msp-1, msp-2, glurp | Cure | Cumulative success | Both corrected and uncorrected |
Valea [63] | PK study | 63 | Passively | No | Botha | Full | msp-1, msp-2, glurp | Cure | Proportion | Both corrected and uncorrected |
Juma [64] | PK study | 28 | INA | No | Symptomatic | Full | INA | INA | INA | INA |
Mosha [65] | PK study | 42 | Not followed | No | Symptomatic | Full | msp-2 | Cure &Â failure | Proportion | Uncorrected only |
Nyunt [66] | PK study | 42 | Not followed | No | Symptomatic | INA | msp-1, msp-2 and 4 microsatellites | Cure &Â failure | Proportion | Uncorrected only |
PK study | 28 | Not followed | No | INA | First dose and last dose | msp-2 | Cure &Â failure | Proportion | Both corrected and uncorrected | |
Adam [69] | Single-arm | 28 | Every 2Â weeks | Yes (CHQ) | Symptomatic | Full | No | Failure | Number | No PCR |
Adam [70] | Single-arm | 28 | Every 2Â weeks | Yes (CHQ and Q) | Symptomatic | Full | No recurrence | Cure | Proportion | No recurrence |
Adegnika [71] | Single-arm | 56 | Only at delivery | No | Botha | First dose | No | Cure | Proportion | No PCR |
Adam [72] | Single-arm | 28 | Every 2Â weeks | No | Symptomatic | Full | No recurrence | Cure | Proportion | No recurrence |
Ndiaye [73] | Single-arm | 42 | Only at delivery | No | Symptomatic | Full | No recurrence | Cure | Number | No recurrence |
Iribhogbe [74] | Single-arm | 28 | Not followed | No | Symptomatic | INA | No | Failure | Proportion | No PCR |
McGready [75] | Cohort | 42 | Weekly | 68% retreatment (Q/MQ) | Botha | Full | No | Failure | Cumulative failure | No PCR |
McGready [76] | Cohort | 28 | Weekly | 45% retreatment (Q/MQ) | Botha | INA | No | Failure | Proportion | No PCR |
McGready [77] | Cohort | 42 | Weekly | 58% retreatment (Q/MQ) | Botha | Full | No | Failure | Proportion Cumulative failure | No PCR |
Laochan [78] | Collation of studies | Delivery | Weekly | Some | Botha | INA | msp-1, msp-2, glurp | Time to recrudescence | Geometric mean | Corrected only |
McGready [79] | Cohort | 28 | Weekly | Some | Botha | Recorded | No | Failure | Proportion | No PCR |
McGready [80] | Cohort | 42 | Weekly | Yes (Q/QC/AS/AC) | Botha | Full | msp-1, msp-2, glurp | Cure | Proportion | No recurrence |
Villegas [81] | Cohort | INA | INA | INA | Symptomatic | Full | INA | Cure | INA | INA |
Rijken [82] | Cohort | 63 | Weekly | Yes (Q/QC/AS/AC) | Botha | Full | Yes | Cure | Cumulative success | Corrected only |
Rulisa [83] | Cohort | 56 | INA | Some | Symptomatic | No | No | Cure &Â failure | Proportion | No PCR |
Cohort | Delivery | Every 4Â weeks | Not excluded | Botha | INA | 6 microsatellite markers | Failure | Proportion | Both corrected and uncorrected |