| Methods |
Randomised controlled trial.
Multicentre (Swedish and USA) study.
Randomisation method: numbered sealed envelopes.
Assessors were blinded.
Patient stratification: not used.Power calculation: not performed.
Intention‐to‐treat analysis: performed.
Sub‐group analysis: not performed.
Follow‐up: 1 to 2 and 4 to 6 weeks after completion of treatment. |
| Participants |
Number of patients: 134.
Clinically and microbiologically evaluable patients: 113.
55 (Piperacillin/tazobactam, P‐T) versus 58 (Imipenem/cilastatin, I‐C).
Mean age: 52.9 (P‐T), 54.0 (I‐C).
Age range:16‐92.
Inclusion criteria: > 18 years of age and suspected intra‐abdominal infections.
Exclusion criteria: pregnant or lactating women; known allergy to study drugs; patients with infection resistant to study drugs; septic shock; patients treated with probenecid or other investigational drugs; antimicrobial agents within last 72 hours; impaired renal or hepatic function; serum bilirubin, transaminases or ALP greater than 3 times the upper normal limit; CNS disorders; and concomitant infection other than intra‐abdominal infection. |
| Interventions |
2 regimens:
1) Piperacillin 4 g (8 hourly) and tazobactam 500 mg (8 hourly).
2) Imipenem 500 mg (8 hourly) and cilastatin 500 mg (8 hourly).
Timing of antibiotic infusion: intra‐operatively.
Length: > 3 days. |
| Outcomes |
Clinical (ITT analysis) and bacteriological success.
Mortality.
Superinfection.
Adverse reactions (ITT analysis). |
| Notes |
73/134 (54%) patients had complicated appendicitis.
Piperacillin/tazobactam statistically more effective than imipenem/cilastatin.
Majority of adverse events were mild ‐ diarrhoea and nausea.
Results also published elsewhere as Eklund 1993 (excluded studies). |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
