| Methods |
Randomised parallel trial.
Multicentre (20 Italian centres) study.
Randomisation method: not stated.
Blinding of assessors: not stated.
Patient stratification: using APACHE II.
Power calculation: not performed.
Intention‐to‐treat analysis: not performed.
Sub‐group analysis: performed.Follow up: 7‐10 days after cessation of therapy. |
| Participants |
Number of patients: 287
Evaluable patients: 201.
101 (Imipenem/cilastatin, I‐C) versus 100 (Meropenem, M).
Mean age: 54.4 (range: 19‐92) years.
Male:female ratio = 1.3:1.
Mean APACHE II score: 6.4 (I‐C), 5.9 (M).
APACHE II score <11: n = 81 (80%) (I‐C) vs 85 (85%) (M).
APACHE II score 11‐20: n = 20 (20%) (I‐C) vs 13 (13%) (M).
APACHE II score >20: n = 0 (0%) (I‐C) vs 2 (2%) (M).
Inclusion criteria: > 18 years of age, with intra‐abdominal infections extending beyond the organ wall, temperature > 38 degrees C, or a WBC > 10500/mm, with symptoms and physical findings (e.g. abdominal pain and tenderness) and radiological, ultrasonic or radionuclide (if performed) changes consistent with intra‐abdominal infection.
Exclusion criteria: lactating or pregnant patients; allergy, hypersensitivity or severe reaction to study antibiotics; rapidly progressive or terminal illness; severe hepatic or renal disease; concomitant infection that would interfere with evaluation of response to study antibiotics; participation in any clinical study involving antibiotics; previous participation in this study; inability to give consent; traumatic bowel perforation requiring surgery within 12 hours; perforation or gastroduodenal ulcers requiring surgery within 24 hours, or other intra‐abdominal processes in which the primary aetiology was unlikely to be infectious. Also excluded were patients who had undergone a percutaneous drainage procedure rather than a surgical procedure. |
| Interventions |
2 regimens:
1) Imipenem/cilastatin 500 mg (8 hourly).
2) Meropenem 1000 mg (8 hourly).
Timing of antibiotic infusion: not stated.Length: > 5 days. |
| Outcomes |
Clinical and microbiological success.
Adverse reactions (ITT analysis). |
| Notes |
Patients were stratified according to APACHE II score and then randomised sequentially into the 2 treatment groups.
42/201 (46%) patients had complicated appendicitis.
No statistically significant difference shown. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
