Long 2011
| Methods | Randomised clinical trial, single‐centre, emergency department outpatients in China | |
| Participants |
Inclusion criteria: CAP with X‐ray confirmation in an outpatient setting Exclusion criteria: pregnancy, commencement of antibiotic therapy ≥ 48 h before enrolment, systemic immune deficiency, withholding of life‐support and active tuberculosis Included in this analysis: 156 out of 172 randomised patients: 16 post randomisation exclusions (6 lost to follow‐up, 7 withdrew consent, 3 with final diagnosis other than CAP) |
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| Interventions | Guiding antibiotic decisions in CAP patients with repeated levels Algorithm used in this study: a procalcitonin level of less than 0.1 µg/L suggested the absence of bacterial infection and the initiation or continuation of ABs was strongly discouraged. A procalcitonin level between 0.1 and 0.25 µg/L indicated that bacterial infection was unlikely and the initiation or continuation of ABs was discouraged. A procalcitonin level of 0.25 µg/L or greater was considered to indicate a possible bacterial infection and the initiation or continuation of AB therapy was encouraged. Re‐evaluation of the clinical status and measurement of procalcitonin levels was recommended after 6 to 12 h in all patients from whom ABs were withheld |
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| Outcomes |
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| Notes |
Funding: the study was sponsored by a grant from the Shanghai Fifth People′s Hospital Science Foundation (09YRCPY11) Follow‐up: fixed period of 4 weeks Registration: NA |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Odd and even patient ID numbers |
| Allocation concealment (selection bias) | High risk | Odd and even patient ID numbers |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Open‐label trial where physicians knew in which group patients were and where procalcitonin levels were only communicated in the intervention arm |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Non‐blinded study members |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Follow‐up for mortality: 156 (156) (100%) |
| Selective reporting (reporting bias) | Low risk | No selective reporting (oral verification with first author) |
| Other bias | Unclear risk | Adherence to procalcitonin protocol not reported/assessed |