| Methods |
Randomised controlled trial.
Multicentre (USA) study between February 1990 and January 1993.
Randomisation method: computer generated code.
Blinding of assessors: not used.
Patient stratification: not used.
Power calculation: not performed.
Intention‐to‐treat analysis: performed.
Sub‐group analysis: not performed.
Follow up: 4 weeks. |
| Participants |
Number of patients: 87.
Clinically evaluable patients: 76.
47 (Cefoperazone/sulbactam, C‐S) versus 29 (Gentamicin/clindamycin, G‐C).
Mean age: 49 (C‐S), 46 (G‐C).
Age range: 18‐92.
Inclusion criteria: > 18 years of age, suspected or known intra‐abdominal infection bacterial origin and either localised or generalised peritonitis.
Exclusion criteria: terminally ill, pregnant or lactating women, patients with known hypersensitivity to study drugs, impaired immunological or haematological function (WBC < 500 X 1000000/L, those on immunosuppressive drugs or those with HIV infection), estimated creatinine clearance < 30 mL/min/1.73 m2 body surface area), patients unable to refrain from alcohol for 3 days after therapy, participation in another drug trial, requiring antimicrobial therapy other than study drugs, successful antibiotic therapy within last 4 days and patients with acute abdominal trauma who had not yet developed peritonitis. |
| Interventions |
2 regimens:
1) Cefoperazone 2 g and sulbactam 1 g (12 hourly) [Interval of cefoperazone/sulbactam could be shortened to every 6‐8 hour at the discretion of the principal investigator].
2) Gentamicin (based on body weight) and clindamycin 900 mg (8 hourly).
Gentamicin levels monitored at peak 4‐8 mg/L and trough < 2 mg/L.
Timing of antibiotic infusion: pre‐operatively or during the surgical procedure.
Length: not stated. |
| Outcomes |
Clinical and microbiological success.
Mortality.
Superinfection.
Adverse reactions. |
| Notes |
24/76 (32%) of patients had complicated appendicitis.
No statistically significant difference shown.
Supported by grant from Pfizer Pharmaceuticals. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
