| Methods |
Randomised controlled trial.
Multicentre (3 Swiss centres) study between December 1993 and May 1996.
Randomisation method: sealed sequential envelopes.
Assessors were blinded.
Patient stratification: not performed.
Power calculation: not performed.
Intention‐to‐treat analysis: not performed.
Sub‐group analysis: not performed.
Follow up: 2‐4 weeks. |
| Participants |
Clinically evaluable patients: 159.
76 (Piperacillin/tazobactam, P‐T), versus 83 (Imipenem/cilastatin, I‐C).
Mean age: 59.1 (P‐T), 59.1 (I‐C).
Mean APACHE II score: 8.3 +/‐ 6.3 (P‐T), 7.3 +/‐ 4.9 (I‐C).
Inclusion criteria: > 16 years old and peritonitis diagnosed intraoperatively.
Exclusion criteria: pregnancy or lactating, expected survival < 48 hours, known allergy to study drugs, HIV, concomitant infection, infection with micro‐organism known to be resistant to study drugs, deranged LFT ( transaminases, ALP and bilirubin > 3 times upper limit of normal). |
| Interventions |
2 regimens:
1) Piperacillin/tazobactam 4.5 g (8 hourly).
2) Imipenem/cilastatin 500 mg (6 hourly).
Timing of antibiotic infusion: not stated.
Length: not stated. |
| Outcomes |
Clinical success.
Mortality.
Intra‐abdominal abscess and clinical sepsis.
Duration of therapy. |
| Notes |
Study compared both regimens in nosocomial pneumonia and peritonitis. Results were clearly illustrated for both groups of patients.
% of patients with complicated appendicitis was not stated.
No statistically significant difference shown.
Study supported by grant from Wyeth‐Lederle and MSD‐Chibret. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
