Table 1 Clinical study demographics, sample collection, and treatment outcomes

From: Optimal dosing of dihydroartemisinin-piperaquine for seasonal malaria chemoprevention in young children

Parameter

PKPD group (primary analysis)

PD group (external validation)

Total

Total no. of children

179

562

741

Total no. of samples (capillary/venous plasma)

466/71

NA

NA

Total monthly dose of piperaquine base (mg kg−1)

29.2 (18.0–39.0)

29.7 (16.7–55.4)

29.7 (16.7–55.4)

Total monthly dose of dihydroartemisinin (mg kg−1)

6.32 (3.90–8.45)

6.43 (3.61–12.0)

6.43 (3.61–12.0)

Continuous and categorical covariates at admission

 Age (months)

32.1 (2.33–58.1)

24.0 (3.00–59.3)

26.1 (2.33–59.3)

 Body weight (kg)

11.0 (4.20–18.3)

10.5 (5.00–21.0)

10.6 (4.20–21.0)

 Axillary temperature at admission (ºC)

36.7 (35.0–39.3)

36.7 (35.0–40.4)

36.7 (35.0–40.4)

 Number of patients with malaria (%)

71 (39.6%)

250 (44.5%)

312 (42.1%)

 Number of male patients (%)

93 (51.9%)

277 (49.3%)

370 (49.9%)

Treatment outcomes during follow-up

 Number of patients with malaria (%)

110 (61.4%)

322 (57.3%)

432 (58.2%)

 Time-to malaria (days)

107 (28–149)

90 (13–153)

90 (13–153)

 Parasitaemia in patients with malaria (parasites μL−1)

48,926 (64–1,496,212)

36,081 (12–260,000)

39,275 (12–1,496,212)

 Number of patients lost before day 90 (%)

4 (2.19%)

18 (3.20%)

22 (2.95%)

 Follow-up time of lost patients (days)

60 (60–62)

60.5 (20–80)

60 (20–89)

  1. Data from the children in the PKPD group were used to develop the pharmacokinetic and pharmacodynamic model, and the data from the children in the PD group (no blood samples collected) were used for external validation of the final pharmacodynamic model. All values are given as median (range) unless otherwise indicated
  2. PK pharmacokinetics, PD pharmacodynamics, NA not available