Table 1.
Patient characteristics.
| DP regimen (received from age 8 to 104 weeks) | ||
|---|---|---|
| Characteristic | DP every 12 weeks | DP every 4 weeks |
| Number randomized | 184 | 96 |
| Female sex, n (%) | 92 (50%) | 45 (47%) |
| Birth weight, median (2.5%, 97.5%) | 3000 (1932–3807) | 2965 (1694–3688) |
| Gestational age, median (2.5%, 97.5%) | 39.9 (33.2–41.4) | 39.0 (33.0–41.8) |
| Low birth weight (<2500 gr), n (%) | 21 (11.4%) | 14 (14.6%) |
| Preterm birth (<37 weeks), n (%) | 14 (7.6%) | 12 (12.5%) |
| Maternal IPTp regimen, n (%) | ||
| SP every 8 weeks | 97 (53%) | – |
| DP every 8 weeks | 43 (23%) | 46 (48%) |
| DP every 4 weeks | 44 (24%) | 50 (52%) |
| Weight for age z-score at age 8 weeks, median (2.5%, 97.5%) | −0.22 (−2.92–1.36) | −0.31 (−3.75–1.21) |
| Height for age z-score at age 8 weeks, median (2.5%, 97.5%) | 0.03 (−3.27–2.06) | −0.39 (−4.38–1.18) |
| Sparse sampling—PPQ concentrations (280 children) | ||
| Routinea Venous, n (% eligible) | 378 (97%) | 166 (91%) |
| Routinea Capillary, n (% eligible) | 1890 (99%) | 945 (99%) |
| Non-routineb PPQ concentrations, n | 200 | 25 |
| Intensive sampling—PPQ concentrations (32 children) | ||
| Venous, n | 403 | 180 |
| Capillary, n | 273 | 113 |
| Plasmodium falciparum antimalarial resistance genotypes from first episode of parasitemia after DPc | ||
| Episodes of parasitemia through 112 weeks of age | 135 | 17 |
| pfmdr1 86Y (%) | ||
| Successful genotypes, (%) | 122 (90%) | 12 (71%) |
| Mutant infectionsc, (%) | 9 (7.4%) | 1 (8.3%) |
| pfmdr1 184F (%) | ||
| Successful genotypes, (%) | 130 (96%) | 12 (71%) |
| Mutant infectionsc, (%) | 79 (60.8%) | 6 (50%) |
| pfmdr1 1246Y (%) | ||
| Successful genotypes, (%) | 121 (90%) | 10 (59%) |
| Mutant infectionsc, (%) | 26 (21%) | 1 (10%) |
| pfcrt 76T (%) | ||
| Successful genotypes, (%) | 122 (90%) | 9 (53%) |
| Mutant infectionsc, (%) | 47 (39%) | 3 (33%) |
aRoutine indicates PPQ concentrations taken at pre-specified study visits.
bNon-routine PPQ concentrations were taken at non-specified study visits (i.e., at the time of parasitemia).
cMutant parasites included polyclonal infections with wild-type and mutant and pure mutant infections, only the first infection detected after receiving a course of DP was considered for genotyping.