Schuetz 2009.
Methods | Randomised clinical trial, multicentre, 6 sites in Switzerland | |
Participants |
Inclusion criteria: Clinical diagnosis of CAP, ECOPD, bronchitis with X‐ray confirmation Exclusion criteria: People with active intravenous drug use, severe immunosuppression other than corticosteroid use, life‐threatening medical comorbidity leading to possible imminent death, hospital‐acquired pneumonia (development of pneumonia 48 hours after hospital admission or if they were hospitalised within 14 days before presentation), and chronic infection necessitating antibiotic treatment Included in this analysis: 1359 out of 1381 randomised participants; 22 post randomisation exclusions due to withdrawal of consent |
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Interventions | Guiding antibiotic decisions in emergency department patients with different ARIs with repeated measurements Algorithm used in this study: Initiation or continuation of ABs was strongly discouraged if PCT was less than 0.1 µg/L and discouraged if levels were 0.25 µg/L or lower. Initiation or continuation of ABs was strongly encouraged if PCT was higher than 0.5 µg/L and encouraged if levels were higher than 0.25 µg/L. If ABs were withheld, hospitalised patients were clinically re‐evaluated and PCT measurement was repeated after 6 to 24 hours. |
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Outcomes |
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Notes |
Funding: This work was supported in part by grant SNF 3200BO‐116177/1 from the Swiss National Science Foundation and contributions from santésuisse and the Gottfried and Julia Bangerter‐Rhyner‐Foundation, the University Hospital Basel, the Medical University Clinic Liestal, the Medical Clinic Buergerspital Solothurn, the Cantonal Hospitals Muensterlingen, Aarau and Lucerne, respectively, the Swiss Society for Internal Medicine, and the Department of Endocrinology, Diabetology and Clinical Nutrition, University Hospital Basel. B·R·A·H·M·S Inc, the major manufacturer of the PCT assay, provided all assay‐related material, Kryptor machines if not already available onsite, and kits and maintenance required for 10,000 measurements related to the study. Follow‐up: Fixed follow‐up period after 30 days and 180 days Registration: ISRCTN95122877 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Independent statistician created randomisation scheme. |
Allocation concealment (selection bias) | Low risk | Central randomisation using a study web site |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Open‐label trial where physicians knew to which group participants had been assigned and where PCT levels were only communicated in the intervention arm |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Interviews by blinded medical students, data safety monitoring board |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Follow‐up for mortality: 1358/1359 (100%) |
Selective reporting (reporting bias) | Low risk | Outcomes match previously published protocol. |
Other bias | Low risk | 91% adherence to PCT algorithm in PCT group |