Methods |
Prospective parallel randomised controlled trial.
Single centre (Greek) study.
Randomisation method: unclear.
Blinding of assessors: not used.
Patient stratification: not performed.
Power calculation: not used.
Intention‐to‐treat analysis: not performed.
Sub‐group analysis: not performed.Follow up: > 30 days. |
Participants |
Number of patients: 62.
Mean age: 51.3 (Meropenem, M), 45.5 (Imipenem/cilastatin, I‐C).
Age range: 18‐74.
Clinically evaluable patients: 59.
28 (M) versus 31 (I‐C).
Inclusion criteria: > 18 years of age, presumptive diagnosis of intra‐abdominal infections diagnosed clinically on the basis of symptoms and signs of general or local peritonitis.
Exclusion criteria: known allergy to study drugs,pregnancy, severe underlying disease rendering the therapeutic results non‐assessable on post‐treatment follow up, concurrent or previous antibiotic administration. |
Interventions |
2 regimens:
1) Imipenem/cilastatin 1 g (8 hourly).
2) Meropenem 1 g (8 hourly).
Timing of antibiotic infusion: at induction of anaesthesia.
Length: > 5 days. |
Outcomes |
Clinical success. |
Notes |
26/62 (42%) of patients had complicated appendicitis.
No statistically significant difference was shown. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |