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. 2012 Sep 12;2012(9):CD007498. doi: 10.1002/14651858.CD007498.pub2

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)
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
Outcomes
  • Antibiotic use

  • Mortality

  • ICU admission

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
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