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