CORTEEC is a multi-centre, phase II, double blind, parallel-group, placebo-controlled clinical trial. We recruited children with parapneumonic pleural effusion at 9 Spanish hospitals. Participants were randomly placed into placebo or dexamethasone in a 1:1 ratio.
Patients were scheduled for 0.25 mg/kg/qid of intravenous dexamethasone or placebo. The primary endpoint was the time to recovery (in hours). We performed an intention-to-treat analysis with all patients with at least 1 administration of study drug.
A total of 60 patients were assigned to dexamethasone (n=30) and placebo (n=30) between January 1, 2010, and May 31, 2015. A total of 57 (95%) patients completed the protocol.
Dexamethasone was better than placebo with respect to time to recovery. The hazard ratio (HR) for recovery was 1.85 (95% confidence interval [CI], 1.08 to 3.17; p=0.024). In the multivariate Cox model, the superiority of dexamethasone was consistent, regardless of severity group (HR, 1.73; 95% CI, 1.02 to 2.9; p=0.042). The median time to recovery for patients on dexamethasone was 68 hours (2.8 days, 38%) shorter than patients on placebo. The median time to recovery for patients with simple effusion on dexamethasone was 76 hours (3.1 days, 61%) shorter than patients with simple effusion on placebo. The median time to recovery for patients with complicated effusion on dexamethasone was 14 hours (0.5 days, 6%) shorter than patients with complicated effusion on placebo. The difference in the effect of dexamethasone in the two severity groups was not statistically significant (p=0.138 for interaction). There were no significant differences in complications or adverse events attributable to the study drugs, except for hyperglycaemia. Fifteen (50%) of patients on DXM and 6 (20%) of patients on placebo had hyperglycaemia (p=0.01).
Risk ratio of dexamethasone for hyperglycaemia was 4; 95% CI, 1.2 to 12.5.
In this trial, dexamethasone was a safe and effective adjunctive therapy for parapneumonic pleural effusion.
F. Baquero-Artigao, None
M. L. Navarro, None
R. Velasco, None
M. Penin, None
D. Moreno, None
P. Rojo, None