| Methods |
Randomised, double blinded controlled trial.
Single centre (USA) study between March 1989 and February 1990.
Randomisation method: unstated.
Assessors were blinded.
Patient stratification: not used.
No power calculation.
Intention‐to‐treat analysis: not performed.
Sub‐group analysis: not performed.
Follow up: not stated. |
| Participants |
Number of patients: 96.
50 (Cefepime/metronidazole, C‐M) versus 46 (Gentamicin/clindamycin, G‐C).
Mean age: 30.5 +/‐ 10.5 (C‐M), 29.0 +/‐ 9.8 (G‐C).
Age range: 18‐64.
Inclusion criteria: patients with clinical signs of gangrenous or perforated appendicitis (fever > 38 degrees C, diffuse abdominal tenderness, leucocyte count > 13000 ml and duration of symptoms < 24 hours).
Exclusion criteria: < 18 or > 65 years old, haemodynamic instability (systolic blood pressure < 100 mmHg), pregnant or nursing women, granulocyte count < 500 /ml, serum creatinine > 2 mg/dl, active hepatic disease (ALT/AST > 3x normal), life threatening infection (including evidence of septic shock), CNS involvement, failure of more than one organ, antibiotic use in the last six weeks, and history of allergy to study drugs. |
| Interventions |
2 regimens:
1) Cefepime 2 g (12 hourly) and metronidazole 500 mg (8 hourly).
2) Gentamicin 1.5 mg/kg (8 hourly) and clindamycin 900 mg (8 hourly).
Gentamicin serum level maintained at 4.5 to 8.5 mcg/ml.
Timing of antibiotic infusion: pre‐operatively.Length: febrile for 48 hours, < 14 days. |
| Outcomes |
Clinical success.
Wound infection, intra‐abdominal abscess.Adverse reactions (ITT analysis).
Duration of therapy, hospitalised stay and time to defervescence. |
| Notes |
All patients had complicated appendicitis.
No statistically significant difference shown. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
