Alfredo Tagarro1, Enrique Otheo2, Fernando Baquero-Artigao3, María-Luisa Navarro4, Rosa Velasco5, Marta Ruiz6, María Penín7, David Moreno8, Pablo Rojo9, Rosario Madero10. 1. Department of Pediatrics, University Hospital Infanta Sofía, San Sebastián de los Reyes, Spain; Biomedical School, Universidad Europea, Madrid, Spain. Electronic address: alfredotagarro@hotmail.com. 2. Department of Pediatrics, University Hospital Ramón y Cajal, Madrid, Spain; Medical School, Universidad de Alcalá, Madrid, Spain. 3. Pediatrics, Tropical and Infectious Diseases Department, University Hospital La Paz, Madrid, Spain. 4. Pediatric Infectious Diseases Unit, University Hospital Gregorio Marañón, Madrid, Spain. 5. Department of Pediatrics, Toledo University Hospital, Toledo, Castilla-La Mancha, Spain. 6. Department of Pediatrics, Getafe University Hospital, Getafe, Spain. 7. Department of Pediatrics, University Hospital Príncipe de Asturias, Alcalá de Henares, Madrid, Spain. 8. Department of Pediatrics, University Hospital Carlos Haya, Málaga, Andalucía, Spain. 9. Pediatric Infectious Diseases Unit, University Hospital 12 de Octubre, Madrid, Spain. 10. Biostatistics Unit, University Hospital La Paz, Madrid, Spain.
Abstract
OBJECTIVE: To assess whether dexamethasone (DXM) decreases the time to recovery in patients with parapneumonic pleural effusion. STUDY DESIGN: This was a multicenter, randomized, double blind, parallel-group, placebo-controlled clinical trial of 60 children, ranging in age from 1 month to 14 years, with community-acquired pneumonia (CAP) and pleural effusion. Patients received either intravenous DXM (0.25?mg/kg/dose) or placebo every 6 hours over a period of 48 hours, along with antibiotics. The primary endpoint was the time to recovery in hours, defined objectively. We also evaluated complications and adverse events. RESULTS: Among the 60 randomized patients (mean age, 4.7 years; 58% female), 57 (95%) completed the study. Compared with placebo recipients, the patients receiving DXM had a shorter time to recovery, after adjustment by severity group and stratification by center (hazard ratio, 1.95; 95% CI, 1.10-3.45; P?=?.021). The median time to recovery for patients receiving DXM was 68 hours (2.8 days) shorter than patients receiving placebo (109 hours vs 177 hours; P?=?.037). In exploratory subgroup analysis, the median time to recovery for patients with simple effusion receiving DXM was 76 hours (3.1 days) shorter than for patients with simple effusion receiving placebo (P?=?.017). The median time to recovery for patients with complicated effusion receiving DXM was 14 hours (0.5 days) shorter than for patients with complicated effusion receiving placebo (P?=?.66). The difference in the effect of DXM in the 2 severity groups was not statistically significant (P?=?.138 for interaction). There were no significant differences in complications or adverse events attributable to the study drugs, except for hyperglycemia. CONCLUSION: In this trial, DXM seemed to be a safe and effective adjunctive therapy for parapneumonic pleural effusion. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01261546.
RCT Entities:
OBJECTIVE: To assess whether dexamethasone (DXM) decreases the time to recovery in patients with parapneumonic pleural effusion. STUDY DESIGN: This was a multicenter, randomized, double blind, parallel-group, placebo-controlled clinical trial of 60 children, ranging in age from 1 month to 14 years, with community-acquired pneumonia (CAP) and pleural effusion. Patients received either intravenous DXM (0.25?mg/kg/dose) or placebo every 6 hours over a period of 48 hours, along with antibiotics. The primary endpoint was the time to recovery in hours, defined objectively. We also evaluated complications and adverse events. RESULTS: Among the 60 randomized patients (mean age, 4.7 years; 58% female), 57 (95%) completed the study. Compared with placebo recipients, the patients receiving DXM had a shorter time to recovery, after adjustment by severity group and stratification by center (hazard ratio, 1.95; 95% CI, 1.10-3.45; P?=?.021). The median time to recovery for patients receiving DXM was 68 hours (2.8 days) shorter than patients receiving placebo (109 hours vs 177 hours; P?=?.037). In exploratory subgroup analysis, the median time to recovery for patients with simple effusion receiving DXM was 76 hours (3.1 days) shorter than for patients with simple effusion receiving placebo (P?=?.017). The median time to recovery for patients with complicated effusion receiving DXM was 14 hours (0.5 days) shorter than for patients with complicated effusion receiving placebo (P?=?.66). The difference in the effect of DXM in the 2 severity groups was not statistically significant (P?=?.138 for interaction). There were no significant differences in complications or adverse events attributable to the study drugs, except for hyperglycemia. CONCLUSION: In this trial, DXM seemed to be a safe and effective adjunctive therapy for parapneumonic pleural effusion. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01261546.
Authors: Andrey A Komissarov; Najib Rahman; Y C Gary Lee; Galina Florova; Sreerama Shetty; Richard Idell; Mitsuo Ikebe; Kumuda Das; Torry A Tucker; Steven Idell Journal: Am J Physiol Lung Cell Mol Physiol Date: 2018-01-18 Impact factor: 5.464
Authors: Susanna Esposito; Claudia De Guido; Marco Pappalardo; Serena Laudisio; Giuseppe Meccariello; Gaia Capoferri; Sofia Rahman; Claudio Vicini; Nicola Principi Journal: Children (Basel) Date: 2022-04-26
Authors: Deirdre B Fitzgerald; Grant W Waterer; Catherine A Read; Edward T Fysh; Ranjan Shrestha; Christopher Stanley; Sanjeevan Muruganandan; Norris S H Lan; Natalia D Popowicz; Carolyn J Peddle-McIntyre; Najib M Rahman; Seng Khee Gan; Kevin Murray; Yun Chor Gary Lee Journal: Medicine (Baltimore) Date: 2019-10 Impact factor: 1.817