| Methods |
Double‐blinded, randomised controlled trial.
Multi centre (5 USA and Canadian centres) study.
Randomisation method: randomisation with block size of four.
Blinding of assessors: double‐blinded.
Patient stratification: according to APACHE II score.
Power calculation: no stated.
Intention‐to‐treat analysis: performed.Sub‐group analysis: not performed.
Follow up: not stated.
Placebo was used to enable double‐blinding. |
| Participants |
Number of patients: 529.
Clinically evaluable patients: 312.
150 (Clinafloxacin, C) versus 162 (Imipenem/cilastatin, I‐C).
Mean age: 45.5 (C), 46.5 (I‐C).
Inclusion criteria: > 18 years old with signs and symptoms of intra‐abdominal infections and if surgical or percutaneous drainage of an infectious focus was recently performed or necessary.
Exclusion criteria: survival < 48 hours, APACHE II score > 30, known allergy to study drugs, other investigational therapy within last 30 days, impaired liver function, neutropaenia (< 1000 X 1000000 neutrophils/L), previous enrolment in trial, CNS disease, pregnant or breast feeding women and acute renal insufficiency. |
| Interventions |
2 regimens:
1) Clinafloxacin 200 mg (12 hourly) with placebo..
2) Imipenem/cilastatin 500 mg (6 hourly).
Timing of antibiotic infusion: not stated.
Length: > 3 days. |
| Outcomes |
Clinical success.
Mortality (ITT analysis).
Wound infection, intra‐abdominal abscess and clinical sepsis.
Adverse reactions (ITT analysis). |
| Notes |
167/312 (53%) of evaluable patients had complicated appendicitis.
No statistically significant difference shown.
Supported by grants from Parke‐Davis pharmaceutical Research. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
