| Methods |
Randomised controlled trial.
Single centre (Dutch) study between August 1987 and May 1989.
Randomisation method: sealed envelopes.
Blinding of assessors: not used.
Patient stratification: not performed.
Power calculation: not used.
Intention‐to‐treat analysis: not performed.
Sub‐group analysis: performed.
Follow up: not stated. |
| Participants |
Number of patients: 104.
Clinically and microbiologically evaluable patients: N = 80.
38 (Imipenem/cilastatin, I‐C) versus 42 (Aztreonam/clindamycin, A‐C).
Mean age: 58 (I‐C), 64 (A‐C).
Age range: 17‐90.
Inclusion criteria: adults with symptoms of local or generalised intra‐abdominal infections.
Exclusion criteria: < 15 and > 90 years of age, known hypersensitivity to study drugs, immunocompromised (unless on steroids). |
| Interventions |
2 regimens:
1) Imipenem 500 mg (6 hourly) and cilastatin 500 mg (6 hourly).
2) Aztreonam 1 g ((8 hourly) and clindamycin 600 mg (8 hourly).
Timing of antibiotic infusion: intra‐operatively.
Length: > 5 days. |
| Outcomes |
Clinical success.
Mortality.
Wound infection, intra‐abdominal abscess, clinical sepsis, superinfection and remote infection.
Adverse reactions. |
| Notes |
30/80 (38%) of patients had complicated appendicitis.No differences in outcome seen between both arms.
Supported in part by grant from MSD Nederland. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
