| Methods |
Randomised controlled trial.
Multicentre (5 German centres) study between December 1992 and December 1993.
Randomisation method: unclear.
Blinding of assessors: not used.
Patient stratification: using APACHE II score.
Power calculation: performed.
Intention‐to‐treat analysis: performed.
Sub‐group analysis: performed.
Follow up: 2‐4 weeks. |
| Participants |
Number of patients: 94.
Clinically evaluable patients: 83.
43 (Meropenem, M) versus 40 (Cefotaxime/metronidazole, C‐M).
Mean age: 61.5 (M), 56.6 (C‐M).
Age range: 20‐89.
APACHE II score 0‐10: n = 26 (60%) (M) vs 28 (70%) (C‐M).
APACHE II score 11‐20: n = 14 (33%) (M) vs 11(28%) (C‐M).
APACHE II score > 20: n = 1 (2%) (M) vs 1 (2%) (C‐M).
Inclusion criteria: > 18 years old, clinical symptoms and signs of peritonitis (abdominal tenderness, guarding and rigidity) demonstrated during surgery.
Exclusion criteria: pregnant or lactating women, other investigational drugs within last 30 days, antibiotic therapy last 3 days unless organism cultured is resistant to study drugs or still present, concomitant infection, known hypersensitivity to study drugs, sever hepatic failure or neutropaenia (neutrophil < 1000 X 1000000/L), cystic fibrosis, history of seizures and severe underlying disease non expecting to survive > 48 hours. |
| Interventions |
2 regimens:
1) Meropenem 1 g (8 hourly).
2) Cefotaxime 2 g and metronidazole 500 mg (8 hourly).
Timing of antibiotic infusion: not stated.
Length: 5‐10 days. |
| Outcomes |
Clinical and microbiological success.
Mortality (ITT analysis).
Superinfection.
Adverse reactions (ITT analysis). |
| Notes |
31/83 (37%) of patients had perforated appendicitis.
Meropenem shown to be statistically significantly more successful (clinically and microbiologically) than cefotaxime/metronidazole.
Study supported by grant from Zeneca GmbH. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
