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. 2015 Dec 3;2015(12):CD002243. doi: 10.1002/14651858.CD002243.pub3
Methods Randomized controlled trial with 2 parallel groups
3 centres
Participants Adults (n = 61) with both severe CAP and high inflammatory response, defined as levels of C‐reactive protein > 15 mg/dL on admission
Interventions
  • Methlyprednisolone (intravenous bolus of 0.5 mg/kg/12 h for 5 days started within 36 hours of hospital admission)

  • Placebo (normal saline)

Outcomes PRIMARY
  • Rate of treatment failure, which includes early and/or late treatment failure. Early treatment failure was defined as clinical deterioration within 72 hours of treatment, as indicated by development of shock or need for invasive mechanical ventilation not present at baseline, or death. Late treatment failure was defined as radiographic progression (increase of ≥ 50% of pulmonary infiltrates compared with baseline), persistence of severe respiratory failure (PaO2/FiO2 < 200, with respiratory rate ≥ 30 min‐1 in non‐intubated participants), development of shock or need for invasive mechanical ventilation not present at baseline or death between 72 and 120 hours after treatment initiation.


SECONDARY
  • Time to clinical stability

  • Length of ICU and hospital stay

  • In‐hospital mortality

  • Inflammatory markers

  • Safety

Notes Study location: Spain
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated randomization scheme
Allocation concealment (selection bias) Low risk Randomization list kept confidential by the pharmacist
Blinding (performance bias and detection bias) All outcomes Low risk Participants: yes
Care‐givers: yes
Data collectors: yes
Outcome assessors: yes
Data analysts: yes
Incomplete outcome data (attrition bias) All outcomes Low risk Lost to follow‐up: none
Selective reporting (reporting bias) Low risk Access to full protocol and unpublished information
Other bias Low risk Access to full protocol and unpublished information