| Methods |
Randomised controlled trial.
Multi‐centre (Scandinavian) study.
Randomisation method: not stated.
Blinding of assessors: not stated.
Patient stratification: using APACHE II score.
Power calculation: performed.
Intention‐to‐treat and sub‐group analysis were performed.
Follow up: 30 days. |
| Participants |
Number of patients: 515.
Clinically and microbiologically evaluable patients: 306.
161 (Imipenem/cilastatin, I‐C) versus 145 (Cefuroxime/metronidazole, C‐M).
Male:female ratio = 1.3:1.
Age range: 18‐92.
APACHE II score 0‐10: n = 216 (84%) (I‐C) vs 212 (82%) (C‐M).
APACHE II score 11‐20: n = 42 (16%) (I‐C) vs 45 (18%) (C‐M).
Inclusion criteria: untreated or unsuccessfully treated patients with proven or suspected bacterial intra‐abdominal infection or systemic infection originating from the intra‐abdominal region.
Exclusion criteria: renal failure, brain abscess or other CNS disorder, serious concomitant infection, hypersensitivity to study drugs, age < 18 years, pregnancy or breast feeding. |
| Interventions |
2 regimens:
1) Imipenem/cilastatin 1.5‐2.0 g/day.
2) Cefuroxime 3.0‐4.5 g/day and metronidazole 1.0‐1.5 g/day.
Timing of antibiotic infusion: not stated.
Length: > 3 days.
Median treatment time: 6 days.
Median time free from fever: 4 days.
Median time to be discharged from hospital: 9 days. |
| Outcomes |
Clinical and bacteriological success (ITT analysis).
Mortality (ITT analysis).
Adverse reactions (ITT analysis). |
| Notes |
139/306 (45%) patients had complicated appendicitis.
No statistically significant difference shown.
Supported by Merck, Sharp and Dohme. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
