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Table 5 GRADE evidence profile 2: Benzyl penicillin versus amoxicillin for severe pneumonia†

From: Experience developing national evidence-based clinical guidelines for childhood pneumonia in a low-income setting - making the GRADE?

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

  1. † 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?
  2. 1 Indirectness of population (one study conducted in Pakistan, one multicentre, multi-country)
  3. 2 Indirectness of population (study conducted in the UK among children with radiologically confirmed pneumonia)
  4. †Median duration to resolution of signs of pneumonia