Table 2

Primary outcome according to treatment groups

Intervention clusters (N=1155)Control clusters (N=1157)Adjusted* risk difference % (95% CI)
Treatment failure† among all enrolled infants—no. (%)63 (5.4)73 (6.3)−1.0 (−3.0 to 1.1)
Reasons for treatment failure—no. (%)
 Death at any time up to 14 days of enrolment2 (0.2)2 (0.2)
 Hospitalised for any reason or has any indication of hospitalisation‡ on day 6 of enrolment12 (1.0)19 (1.6)
 Persistence of fast breathing§ on day 6 assessment49 (4.2)52 (4.5)
 Serious adverse event of treatment0 (0.0)0 (0.0)
Treatment failure† by subgroupsn/N (%)n/N (%)
Region—no./total no. (%)
 African sites20/436 (4.6)19/361 (5.3)−0.9 (−4.4 to 2.5)
 Asian sites43/719 (6.0)54/796 (6.8)−1.0 (−3.6 to 1.7)
Age categories—no./total no. (%)
 7–28 days38/590 (6.4)42/607 (6.9)−0.7 (−3.7 to 2.1)
 29–59 days25/565 (4.4)31/550 (5.6)−1.4 (−4.2 to 1.4)
Sex—no./total no. (%)
 Male36/685 (5.3)43/667 (6.4)−1.3 (−4.0 to 1.4)
 Female27/470 (5.7)30/490 (6.1)−0.4 (−3.3 to 2.5)
Weight-for-age z score¶—no./total no. (%)
>−2 z score50/905 (5.5)54/898 (6.0)−0.5 (−2.9 to 1.8)
 <−2 z score11/234 (4.7)17/245 (6.9)−0.8 (−6.9 to 5.3)
Respiratory rate (breaths per min)—no./total no. (%)
 60–6935/835 (4.2)49/841 (5.8)−1.6% (−3.8 to 0.7)
 ≥7028/320 (8.7)24/316 (7.6)0.9% (−3.5 to 5.3)
  • *Adjusted for site and cluster.

  • †Defined as (a) death at any time up to 14 days of enrolment; or (b) hospitalised for any reason or has any indication of hospitalisation on day 6 of enrolment (defined as the presence of any sign of deterioration—not able to feed at all or stopped feeding well, convulsion, movement only when stimulated or no movement at all, severe chest indrawing, high body temperature (≥38°C), low body temperature (<35.5°C) or SpO2 <90%) on day 6; or (c) persistence of fast breathing on day 6; or (d) development of serious adverse event of treatment by day 6 such as anaphylactic reaction, severe diarrhoea or generalised severe rash. The primary outcome was ascertained on day 6 (from #b–d) and day 14 (#a) of enrolment by independent outcome assessors.

  • ‡Defined as the presence of any danger sign (not able to feed at all or stopped feeding well, convulsion, movement only when stimulated or no movement at all, severe chest indrawing, high body temperature (≥38°C), low body temperature (<35.5°C)) or SpO2 <90%.

  • §Defined as respiratory rate of ≥60 breaths/min.

  • ¶Information was missing in 16 infants in intervention clusters and 14 in control clusters, who were excluded from this analysis. Two infants each failed treatment in intervention and control clusters.

  • SpO2, oxygen saturation.