| Methods |
Randomized
Multicentered |
| Participants |
Adults 18 to 70 (mean age: 43)
Hospitalized
˜ 90% CAP; ˜ 10% nosocomial |
| Interventions |
Atypical: IV sitafloxacin 400 mg X 1/d
Non‐atypical: IV imipenem/cilastatin 500 mg X 3/d |
| Outcomes |
Clinical success (as defined by investigator) |
| Notes |
Phase II trial |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer‐generated randomization code designed to allocate equal numbers of patients to the 2 treatment groups using the method of random‐permutated blocks of 4 |
| Allocation concealment (selection bias) |
Low risk |
Sealed, serially‐numbered envelopes, each containing details of the treatment allocation for a single patient |
| Incomplete outcome data (attrition bias)
Mortality |
Low risk |
All patients evaluated |
| Incomplete outcome data (attrition bias)
Failure |
Low risk |
All patients evaluated |
| Selective reporting (reporting bias) |
Low risk |
Not identified |
| Other bias |
Unclear risk |
Sponsored |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
None (open label) |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
None (open label) |
