| Methods |
Randomised controlled trial.
Multi centre (2 Spanish centres) study.
Randomisation method: sealed envelopes.
Blinding of assessors: not used.
Patient stratification: APACHE II score.
Power calculation: not performed.
Intention‐to‐treat analysis: performed for clinical success.
Sub‐group analysis: not performed.
Follow up: not stated. |
| Participants |
Number of patients: 160.
Mean age: 46.6 years.
Mean APACHE II score: 3.68 (Cefminox, C), 3.18 (Gentamicin/metronidazole, G‐M)
Clinically evaluable patients: 152.
76 (Cefminox, C) versus 76 (Gentamicin/metronidazole, G‐M).
Inclusion criteria: > 18 years old with symptoms and signs of intra‐abdominal infections.
Exclusion criteria: pregnant or lactating women, known allergy to study drugs, antibiotic therapy within last 72 hours, platelet < 100000 /cubic mm, other investigational drugs within last 30 days, haemodialysis or immunosuppressive therapy, APACHE II score > 35, creatinine > 2.5 mg/dl, cirrhosis or ascites and extra‐abdominal infection. |
| Interventions |
2 regimens:
1) Cefminox 2 g (12 hourly).
2) Gentamicin 80 mg (8 hourly) and metronidazole 500 mg (8 hourly).
Gentamicin levels were monitored but ranges were not stated.
Timing of antibiotic infusion: not stated.
Length: not stated. |
| Outcomes |
Clinical success (ITT analysis).
Mortality.
Wound infection.
Adverse reactions. |
| Notes |
95/160 (59%) of patients had perforated appendicitis.No statistically significant difference shown.Supported by Tedec‐Meiji Farma, S.A., Spain. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
