Table 2 Summary of primary and secondary endpoints by treatment group (ITT population)
From: In vivo susceptibility of Plasmodium falciparum to artesunate in Binh Phuoc Province, Vietnam
Characteristic | Artesunate 2mg/kg | Artesunate 4mg/kg | DHA-Piperaquine | Overall comparisons |
|---|---|---|---|---|
(N=55) | (N=56) | (N=55) | (p-value ) | |
Clearance rate constant (“slope”) K | ||||
[ − loge parasitaemia/hour] $ | ||||
- median (IQR) | 0.20(0.12,0.27) | 0.25(0.11,0.39) | 0.23(0.12,0.33) | 0.19 |
Clearance half life T1/2 [hours] | ||||
- median (IQR) | 3.54(2.61,5.88) | 2.72(1.80,6.31) | 2.98(2.10,5.82) | 0.19 |
- geometric mean (95%CI) | 3.85(3.32,4.46) | 3.32(2.67,3.89) | 3.38(2.89,3.95) | |
-T1/2 > 6.2hours | 11/55(20%) | 15/55(27%) | 10/55(18%) | |
Treatment outcomes – WHO | ||||
[PCR-uncorrected] | ||||
- Early treatment failure (ETF) | 2 (4%) | 0 (0%) | 0 (0%) | |
- Late clinical failure (LTF) | 1(2%) * | 0 (0%) | 0 (0%) | |
- Late parasitological failure | 0 (0%) | 0 (0%) | 1 (2%)£ | |
- Withdrawn or lost from follow-up | 6 (11%) | 10 (18%) | 3 (5%) | |
- Adequate clinical and parasitological response (ACPR) | 46 (84%) | 46 (82%) | 51 (93%) | |
Risk of failure [PCR-uncorrected] | ||||
- Kaplan-Meier analysis (ITT) # | 6% | 0% | 2% | 0.16 |
- Proportion (“per protocol”) | 3/49 (6%) | 0/46 (0%) | 1/52 (2%) | 0.21 |
Risk of failure [PCR-corrected] | ||||
- Kaplan-Meier analysis (ITT) # | 6% | 0% | 0% | 0.04¥ |
- Proportion (“per protocol”) | 3/49 (6%) | 0/46 (0%) | 0/51 (0%) | 0.07 |
Parasite clearance time (PCT100) | ||||
- median (IQR) [hours] # | 60 (36, 78) | 42 (30, 78) | 48 (36, 72) | 0.49 |
- Proportion with PCT>72h # | 0.27 | 0.27 | 0.22 | - |
Parasite-reduction ratio (%) £ | ||||
- at 24 hours – median (IQR) | 48 (5,282) | 212 (11,2931) | 113 (12,561) | 0.02 € |
- at 48 hours – median (IQR) | 3430 (151,Inf) | Inf (217,Inf) | Inf (435,Inf) | - |
Fever clearance time # | ||||
- median (IQR) [hours] | 30 (18, 42) | 24 (12,42) | 24 (18,36) | 0.86 |