Effect of corticosteroids on treatment failure among hospitalized patients with severe community-acquired pneumonia and high inflammatory response: a randomized clinical trial.
- Effect of corticosteroids on treatment failure among hospitalized patients with severe community-acquired pneumonia and high inflammatory response: a randomized clinical trial.
- TRIAL REGISTRATION:
P : patients with both severe community-acquired pneumoniaand a high inflammatory response, which was defined as a level of C-reactive protein greater than 150 mg/L at admission
E : intravenous bolus of 0.5 mg/kg per 12 hours of methylprednisolone (n = 61) for 5 days started within 36 hours of hospital admission.
C : placebo (n = 59)
There was less treatment failure among patients from the methylprednisolone group (8 patients [13%]) compared with the placebo group (18 patients [31%]) (P = .02), with a difference between groups of 18% (95% CI, 3% to 32%).
Corticosteroid treatment reduced the risk of treatment failure (odds ratio, 0.34 [95% CI, 0.14 to 0.87]; P = .02).
In-hospital mortality did not differ between the 2 groups (6 patients [10%] in the methylprednisolone group vs 9 patients [15%] in the placebo group; P = .37); the difference between groups was 5% (95% CI, -6% to 17%).
Hyperglycemia occurred in 11 patients (18%) in the methylprednisolone group and in 7 patients (12%) in the placebo group (P = .34).
T : Multicenter, randomized, double-blind, placebo-controlled trial.
Another major limitation is the long duration of the study because the care of patients could have evolved during this time or many intervening diseases might have influenced the results. However, our protocol for managing patients with
community-acquired pneumonia did not change during these years. We excluded patients with H1N1 influenza.
Time to the first antibiotic dosage was similar in both groups. In addition, we adjusted for the year of admission in the corresponding statistical models. Last, the small differ- ence in the number of events (a difference of only 10 pa- tients) indicates the need for study replication. A new trial is currently ongoing.