Blum 2015.
| Methods |
Study design: Randomised, double‐blind, placebo‐controlled trial Study duration: December 2009 to May 2014 |
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| Participants |
Inclusion criteria
Exclusion criteria
Antibiotic therapy: according to ERS/ESCMID guidelines |
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| Interventions |
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| Outcomes | Primary outcome: time to clinical stability defined as time (days) until stable vital signs for 24 hours Mortality outcome definition: 30‐day all‐cause mortality Other relevant outcomes:
Full agreement between outcomes in registry vs results: only primary outcome defined in registry Full agreement between outcomes in methods vs results: yes, except for timing of CAP scores defined only in results |
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| Notes |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer generated |
| Allocation concealment (selection bias) | Low risk | Allocation was concealed with a prespecified computer‐generated randomisation list kept centrally at the pharmacy of the main study centre. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessor was blinded. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat data presented. |
| Selective reporting (reporting bias) | High risk | Only primary outcome reported in registry, differences in outcome description between methods and results. |
| Other bias | Low risk | Sample size calculation without early stop |