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Table 2 Independent predictors of oral antibiotic failure in chest indrawing WHO non-severe childhood pneumonia

From: Predictors of treatment failure for non-severe childhood pneumonia in developing countries – systematic literature review and expert survey – the first step towards a community focused mHealth risk-assessment tool?

Study overview Addo-Yobo E, Chisaka N et al. Hazir T, Fox LM et al. Addo-Yobo E, Anh DD et al.
Region (countries) Africa (Ghana, South Africa, Zambia) Asia (India, Pakistan, Vietnam) South America (Columbia, Mexico) Pakistan (Asia) Africa (Egypt, Ghana) Asia (Bangladesh, Vietnam)
Data collection dates 1999–2002 2005–2006 2005–2008
Enrollment criteria 3–59 months 3–59 months 3–59 months
Study design Randomized multicenter equivalency study Randomized multicenter equivalency study Multicenter observational study
Intervention arm Oral amoxicillin 45 mg/kg/day for 5 days Oral amoxicillin 80–90 mg/kg/day for 5 days -
Control arm (or standard of care) Intravenous 200,000 IU penicillin G for 2 days then oral amoxicillin 45 mg/kg/day for 3 days (total 5 days) Intravenous ampicillin 100 mg/kg/day for 2 days then oral amoxicillin for 3 days (total 5 days) Amoxicillin 80–90 mg/kg/day for 5 days
Blinding No No -
Study site type(s) Pediatric department of tertiary care hospitals Pediatric department of tertiary care hospitals Pediatric department of tertiary care and second-level hospitals, health centers
Number of study sites 9 7 5
Primary outcome Equivalence Equivalence Treatment failure
Treatment failure definition
Day of assignment Day 3 Day 6 Day 6
Respiratory ratea No No No
Fever >38 °C and LCI No Yes (days 3–6) Yes (day 3)
Fever >38 °C No Yes (day 6) Yes (day 6)
LCI Yes (day 3) Yes (day 6) Yes (day 6)
Convulsions Yes (days 1–3) Yes (days 1–6) Yes (days 1–6)
Abnormally sleepy Yes (days 1–3) Yes (days 1–6) Yes (days 1–6)
Inability to drink Yes (days 1–3) Yes (days 1–6) Yes (days 1–6)
Stridor in calm child No No No
Malnutrition No No No
Cyanosis Yes (days 1–3) Yes (days 1–6) Yes (days 1–6)
SpO2 <80 % at sea-level or <75 % below sea-level (days 1–3) No No
Antibiotic change Yes (days 1–3) No Yes (days 1–6)
Hospitalization No Yes, if related to pneumonia (days 1–6) No
Serious drug reaction Yes (days 1–3) No Yes (days 1–6)
Serious adverse event No Yes (days 1–6) No
New comorbid condition Yes (days 1–3) Yes, if required antibiotic (days 1–6) Yes (days 1–6)
Lost to follow-up Yes (days 1–3) Yes (days 1–6) Yes (day 6)
Study withdrawal Yes (days 1–3) Yes (days 1–6) No
Death Yes (days 1–3) Yes (days 1–14) Yes (days 1–6)
Study participants and description
Sample sizeb 1702 2037 823
Age: 3–11 months 1045/1669 (62.6 %) 1311/2037 (64.4 %) 562/873 (64.4 %)
  12–59 months 624/1669 (37.4 %) 726/2037 (35.6 %) 310/873 (35.5 %)
Treatment failure ratec 328/1702 (19.3 %) 164/2037 (8.1 %) 76/823 (9.2 %)
Independent predictors of treatment failurec OR/RR (95 % CI) Age 3–11 months, 2.72 OR (95 % CI 1.95–3.79) Age 3–5 months, 3.22 OR, (95 % CI 1.87–5.52) Age 3–5 months, 1.96 RR (95 % CI 1.09–3.51)
Very fast breathing, 1.94 OR (95 % CI 1.42–2.65)d Very fast breathing, 1.65 OR (95 % CI 1.07–2.57)d Very fast breathing, 12.5 RR (95 % CI 1.74–89.1)d
SpO2 < 90 %, 2.11 OR (95 % CI 1.6–2.78) Weight for age z score <−2, 1.79 OR (95 % CI 1.23–2.60)  
  1. WHO: World Health Organization; IU: International Units; LCI: lower chest wall indrawing; SpO 2 : peripheral oxygen saturation; OR: odds ratio; RR: relative risk; CI, confidence interval
  2. aRespiratory rate norms: <50 breaths/min for ages 2–11 months; <40 breaths/min for ages 12–59 months
  3. bIf primary outcome of trial was equivalency then intervention and control arm data was combined
  4. cMultivariate logistic regression modeling was used by Addo-Yobo E, Chisaka N et al. and Hazir T while log-linear regression modeling was used by Fox LM et al. Addo-Yobo E, Chisaka N et al. modeled age, very fast breathing, hypoxemia, and amoxicillin. Hazir T, Fox LM et al. modeled sex, age, breastfeeding, weight-for-age z score <−2, very fast breathing, and treatment group (home vs hospital). Addo-Yobo E, Anh DD et al. modeled sex, age, and respiratory rate
  5. dVery fast breathing defined as ≥70 breaths/min for ages 3–11 months and ≥60 breaths/min for ages 12–59 months