Table 5.

GRADE evidence profile 2: Benzyl penicillin versus amoxicillin for severe pneumonia^†

Quality assessment					Summary of findings
					Number of patients		Effect	Quality of evidence
No of studies/Design	Limitations	Inconsistency	Indirectness	Imprecision	amoxicillin	benzyl penicillin	Odds ratio (95% CI)/P value
Outcome 1: Treatment failure based on clinical signs. Assessed at 48 hours [25]and 5 days [28] Importance: Critical
2 RCTs [25,28]	no serious limitations	no serious inconsistency	serious1	no serious imprecision	244/1882 (13.0%)	248/1857 (13.4%)	0.97 (0.80-1.17)	Moderate
Outcome 2: Time to resolution of signs of pneumonia Importance: Critical
1 RCT [27]	no serious limitations	no serious inconsistency	serious2	no serious imprecision	100 (1.3 days) †	103 (1.3 days)†	P = 0.001 for equivalence	Moderate
Outcome 3: Mortality Importance: Critical
No studies	-	-	-	-	-	-	-	-
Outcome 4: Cost Importance: Important
No studies	-	-	-	-	-	-	-	-
Overall quality of evidence: Moderate quality evidence suggests that the two treatments are equivalent for outcomes assessed
Benefits or desired effects	Safety of oral over injectable treatments, convenient dosing schedule (twice daily for amoxicillin versus four times a day for benzyl penicillin)
Risks or undesired effects	None identified
Values and preferences	Painless oral administration for amoxicillin preferable to injectable route required for benzyl penicillin/ampicillin, Mothers like injections; Mothers would not stay in hospital for oral medications; Staff would not feel they were giving a strong enough treatment for a severe disease
Costs	Potential reduction in cost of resources required for injectable treatment including the option of out-patient management
Feasibility	Both antibiotics widely available and in use

^† Clinical question: For HIV-unexposed Kenyan children aged 2 - 59 months without clinical signs of severe malnutrition who meet WHO criteria for severe pneumonia, should parenteral benzyl penicillin/ampicillin be replaced by inpatient oral amoxicillin?

¹ Indirectness of population (one study conducted in Pakistan, one multicentre, multi-country)

² Indirectness of population (study conducted in the UK among children with radiologically confirmed pneumonia)

^†Median duration to resolution of signs of pneumonia