| Methods |
Randomised controlled trial.
Single centre (UK) study.
Randomisation method: sealed envelopes.
Blinding of assessors: not stated.
Patient stratification: not performed.
Power calculation: not used.
Intention‐to‐treat analysis: not performed.
Sub‐group analysis: not performed.
Follow up: until discharge or death. |
| Participants |
Number of patients: 45.
Clinically evaluable patients: 43.
19 (Imipenem/cilastatin, I‐C) versus 24 (Ampicillin/metronidazole/gentamicin, A‐M‐G).
Median age: 76 (I‐C), 68 (A‐M‐G).
Age range: 16‐92.
Inclusion criteria: clinically moderate to severe peritonitis.
Exclusion criteria: < 16 years of age, known hypersensitivity to study drugs,concomitant infection, current antibiotic therapy and pregnant or lactating women. |
| Interventions |
2 regimens:
1) Imipenem/cilastatin 500 mg (6 hourly).
2)Ampicillin 500 mg (6 hourly), metronidazole 500 mg (8 hourly) and gentamicin 80 mg (8 hourly).
Gentamicin levels were monitored but ranges were not stated.
Timing of antibiotic infusion: not stated.
Length: > 5 days. |
| Outcomes |
Clinical and microbiological success.
Wound infection, remote infection and superinfection.
Adverse reactions. |
| Notes |
5/43 (12%) patients had complicated appendicitis.
No statistically significant difference was seen between both regimens.
Study supported by grant from Merck, Sharpe & Dohme. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
