| Methods |
Randomised, double‐blinded controlled trial.
Multicentre (34 USA and Canada centres) study between September 1995 and May 1997.
Randomisation method: not stated.
Assessors were blinded.
Patient stratification: by presence or absence of appendicitis and APACHE II score.
Power calculation: performed.
Intention‐to‐treat analysis: performed.
Sub‐group analysis: not performed.
Follow up: 3‐5 week post‐therapy (1‐3 weeks for appendicitis). |
| Participants |
Number of patients: 459.
Clinical and microbiologically evaluable patients: 250.
134 (Ciprofloxacin/metronidazole, C‐M) versus 116 (Piperacillin/tazobactam, P‐T).
Mean age: 47 (C‐M), 49 (P‐T).
Mean APACHE II score: 9.6 (C‐M), 9.5 (P‐T).
Inclusion criteria: patients > 18 years of age with complicated intra‐abdominal infection requiring surgical intervention or percutaneous drainage in addition to parenteral antibiotics.
Exclusion criteria: pregnant or breast feeding women, allergy, renal insufficiency, an indwelling peritoneal catheter, acute pancreatitis, perforated peptic ulcer or traumatic upper gastrointestinal tract perforation < 24 hours, lower gastrointestinal perforation < 12 hours, APACHE II score > 30, not expected to survive > 48 hours and prior antibiotic therapy for last 24 hours. |
| Interventions |
2 regimens:
1) Ciprofloxacin 400 mg (12 hourly) and metronidazole 500 mg (6 hourly).
2) Piperacillin/tazobactam 3.375 mg (6 hourly).
Timing of antibiotic infusion: pre‐operative or intra‐operatively.
Length: > 3 days for appendicitis, > 5 days for all other diagnoses and < 14 days.
After 48 hours of therapy, patients were assessed for recovery of gastrointestinal function and patients on IV C‐M were switched to oral C‐M. |
| Outcomes |
Clinical (ITT analysis) and bacteriological success.
Mortality (ITT analysis).
Wound infection and superinfection.
Adverse reactions (ITT analysis). |
| Notes |
Overall clinical response: 74% (C‐M) versus 63% (P‐T) (p = 0.047).
ITT analysis on clinical response: 75% (C‐M) versus 69% (P‐T) ( p = 0.213).
118/282 (42%) of patients had complicated appendicitis.
90% of patients had pre‐therapy (< 2 doses of other antibiotics).
Approximately 26% of patients had delayed primary closure of wounds.
Supported by grant from Bayer Corp. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
