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. Author manuscript; available in PMC: 2020 Jul 2.
Published in final edited form as: N Engl J Med. 2020 Jul 2;383(1):24–34. doi: 10.1056/NEJMoa1911998

Table 3.

Comparison of no treatment failure and treatment failure (by Day 3) by Baseline Characteristics of Patients Completed per Protocol Treatment (n=3856)

No treatment failure Treatment failure OR (95% CI) P value
Treatment
Amoxicillin 1878/3710(50.6) 51/146(34.9) Reference
Placebo 1832/3710(49.4) 95/146(65.1) 1.9(1.4-2.7) <0.001
Demographic Indicators
Sex
 Male 1948/3710(52.5) 82/146(56.2) 1.2 (0.8-1.6) 0.39
Age categories in month
 2-11 1707/3710(46.0) 70/146(48.0) Reference
 12-59 2003/3710(54.0) 76/146(52.1) 1.1 (0.8-1.5) 0.65
Maternal years of schooling
 No education 2329/3710(62.8) 88/146(60.3) 0.9 (0.3-2.2) 0.75
 1-5 years 521/3710(14.0) 22/146(15.1) 1.0 (0.4-2.6) 0.94
 6-10 years 746/3710(20.1) 31/146(21.2) 0.9 (0.4-2.5) 0.91
 Above 10 years 114/3710(3.1) 5/146(3.4) Reference
Reported symptoms of
 Diarrhea 280/3710(7.6) 19/146(13.0) 1.8 (1.1-3.0) 0.02
 Fever 2164/3710(58.3) 110/146(75.3) 2.2 (1.5-3.2) <0.001
 Cough 3683/3710(99.3) 145/146(99.3) 1.1 (0.1-7.9) 0.95
 Fast/difficult breathing 2387/3710(64.3) 104/146(71.2) 1.4 (1.0-2.0) 0.09
 Chest in-drawing 47/3710(1.3) 2/146(1.4) 1.1 (0.3-4.5) 0.91
 URTI 1397/3710(37.7) 55/146(37.7) 1.0 (0.7-1.4) 0.99
 Vomiting 63/3710(1.7) 3/146(2.1) 1.2 (0.4-3.9) 0.75
 Measles(within last 3 month) 26/3710(0.7) 1/146(0.7) 1.0 (0.1-7.3) 0.98
Breastfeeding with age categories
 2-5 month 1023/1069(95.7) 44/44(100.0) -- --
 6-11 month 616/637(96.7) 22/26(84.6) 0.2 (0.1-0.6) 0.004
 12-24 month 956/1007(94.9) 44/45(97.8) 2.3 (0.3- 0.40
Immunization a
 Up to date immunization 1838/3710(49.5) 61/146(41.8) 0.7 (0.5-1.0) 0.07
 Up to date PCV and Pentavalent 2293/3710(61.8) 89/146(61.0) 1.0 (0.7-1.4) 0.84
Physical Examination
 Anemia 369/3710(10.0) 23/146(15.8) 1.7 (1.1-2.7) 0.02
 MUAC <11.5 cm b 80/2641(3.0) 4/102(3.9) 1.3 (0.5-3.6) 0.61
 Stunting(HAZ<-2 SD) 1687/3684(45.8) 71/144(49.3) 1.2 (0.8-1.6) 0.41
 Wasting(WHZ<-2SD) 664/3673(18.1) 30/142(21.1) 1.2 (0.8-1.8) 0.36
 Under-weight(WAZ<-2SD) 1543/3703(41.7) 67/145(46.2) 1.2 (0.9-1.7) 0.28
 Temperature ≥37.5 °C 1175/3710(31.7) 74/146(50.7) 2.2 (1.6-3.1) <0.001
RR child
 40-49 1620/2003(80.9) 53/76(69.7) Ref.
 50-59 334/2003(16.7) 19/76(25.0) 1.7 (1.0-3.0) 0.04
 60-69 44/2003(2.2) 3/76(4.0) 2.1 (0.6-6.9) 0.23
 ≥70 5/2003(0.3) 1/76(1.3) 6.1 (0.7- 0.10
RR Infant
 50-59 1463/1707(85.7) 51/70(72.9) Reference
 60-69 221/1707(13.0) 15/70(21.4) 1.9 (1.1-3.5) 0.04
 70-79 20/1707(1.2) 3/70(4.3) 4.3 (1.2- 0.02
 ≥80 3/1707(0.2) 1/70(1.4) 9.6 (1.0- 0.05
Oxygen Saturation
 90-92 467/3710(12.6) 23/146(15.8) Reference
 93-95 990/3710(26.7) 44/146(30.1) 0.9 (0.5-1.5) 0.69
 >95 2253/3710(60.7) 79/146(54.1) 0.7 (0.4-1.1) 0.16
Wheeze 261/3710(7.0) 19/146(13.0) 2.0 (1.2-3.3) 0.007
Household demographics
 HH with Improved drinking waterc 3388/3710(91.3) 130/146(89.0) 0.8 (0.5-1.3) 0.34
 HH with Improved sanitationd 3406/3710(91.8) 137/146(93.8) 1.4 (0.7-2.7) 0.38
HH indoor air qualitye
 Adequate 1991/3710(53.7) 61/146(41.8) Reference
 Inadequate 1719/3710(46.3) 85/146(58.2) 1.6 (1.2-2.2) 0.005

Data reported as n/N(%)

a

Children received age appropriate vaccines doses as per the standard immunization schedule

b

MUAC (Mid Upper Arm Circumference) not applicable for children under 6 month of age

c

HH (Household) with Improved drinking water includes piped water, tube well and bottled water

d

HH with Improved sanitation facilities included septic tanks and pit latrine

e

Indoor air quality index were created from 6 air quality variables includes HH have proper ventilation, smoking inside house, source of fuel wood ,charcoal or animal dung, cooking place , stove type, presence of child near cooking area using Principal Component Analysis. Quartiles were created from PCA score to group sampled population into three categories. A binary variable further created combining lower two quartiles reflecting inadequate air quality.

WAZ-Weight for age Z score, HAZ-Height for age Z score, WHZ-Weight for height Z score