Efficacy of Corticosteroid Therapy in Severe Community-acquired Pneumonia: A Monocentric Single-blinded Randomized Placebo-controlled Trial from a Tertiary Care Center in North India
Anurag Dahra, Vidiyala Sai Sandeep, Kamal Singh, Pritam Singh, Mandeep Singla
Citation Information :
Dahra A, Sandeep VS, Singh K, Singh P, Singla M. Efficacy of Corticosteroid Therapy in Severe Community-acquired Pneumonia: A Monocentric Single-blinded Randomized Placebo-controlled Trial from a Tertiary Care Center in North India. Indian J Respir Care 2024; 13 (3):176-181.
Aim and background: A dysregulated immune response can produce acute lung injury and worsen clinical status of patient by causing organ dysfunction and severe pneumonia. Modulating the immune response can improve the outcome of illness and avoid treatment failures. Glucocorticoids are well-known natural inhibitors of inflammation that can be used as an adjunctive treatment; however, their use still remains controversial. Hence, we planned this study to look at the efficacy of steroids to reduce treatment failure among patients of severe community-acquired pneumonia.
Materials and methods: This was a monocentric, single-blinded, randomized placebo-controlled trial, conducted in 55 patients admitted in Government Medical College and Hospital Sector 32, Chandigarh. Participants were enrolled after they met all inclusion and exclusion criteria over a period of 12 months from January 2023 till December 2023. After enrollment, they were randomized through a 1:1 ratio to receive injection methylprednisolone 0.5 mg/kg q12h for 5 days and placebo along with standard antibiotic therapy. Outcomes included assessment of treatment failure, length of hospital stay, and mortality. The collected data was analyzed with Statistical Package for Social Sciences (SPSS) software, IBM manufacturer, Chicago, USA, version 26.0.
Results: In this study of 55 patients, 50 were included for analysis, with 3 leaving against medical advice and 2 withdrawing consent. Both groups had a mean age over 50 years. Initial hemodynamic stability was faster in intervention group (p = 0.025), but delayed stability was similar in both. Mortality during hospitalization (28 vs 40%; p = 0.37) and length of stay (6 days vs 8 days; p = 0.815) showed no difference. Early (57 vs 73%; p = 0.256) and late clinical stability (p = 0.572) were not significantly different. Likewise, early treatment failure (44 vs 64%; p = 0.156) and late treatment failure (18.18 vs 26.3%; p = 0.705) did not differ. Overall, primary and secondary outcomes did not show any statistically significant distinctions.
Conclusion: In treating severe pneumonia, the use of an adjuvant corticosteroid was found to be statistically equivalent to using an antibiotic alone in this trial. Nonetheless, the intervention group showed a discernible improvement in clinical indicators and a decrease in complications, duration of hospital stay, mortality, and treatment failure rate, all of which remained below the threshold of statistical significance.
Mandell LA, Wunderink RG, Anzueto A, et al. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis Off Publ Infect Dis Soc Am 2007;44 (Suppl 2):S27–S72. DOI: 10.1086/511159
File TM, Ramirez JA. Community-acquired pneumonia. N Engl J Med 2023;389(7):632–641. DOI: 10.1056/NEJMcp2303286
Huang J, Guo J, Li H, et al. Efficacy and safety of adjunctive corticosteroids therapy for patients with severe community-acquired pneumonia. Medicine (Baltimore) 2019;98(13):e14636. DOI: 10.1097/MD.0000000000014636
Tagami T, Matsui H, Horiguchi H, et al. Low-dose corticosteroid use and mortality in severe community-acquired pneumonia patients. Eur Respir J 2015;45(2):463–472. DOI: 10.1183/09031936.00081514
Martin-Loeches I, Torres A, Nagavci B, et al. ERS/ESICM/ESCMID/ALAT guidelines for the management of severe community-acquired pneumonia. Eur Respir J 2023;61(4):2200735. DOI: 10.1183/13993003.00735-2022
Dhar R. Pneumonia: review of guidelines. J Assoc Physicians India 2012;60 Suppl:25–28. PMID: 23155822.
Almirall J, Serra-Prat M, Bolíbar I, et al. Risk factors for community-acquired pneumonia in adults: a systematic review of observational studies. Respir Int Rev Thorac Dis 2017;94(3):299–311. DOI: 10.1159/000479089
Torres A, Peetermans WE, Viegi G, et al. Risk factors for community-acquired pneumonia in adults in Europe: a literature review. Thorax 2013;68(11):1057–1065. DOI: 10.1136/thoraxjnl-2013-204282
Torres A, Chalmers JD, Dela Cruz CS, et al. Challenges in severe community-acquired pneumonia: a point-of-view review. Intensive Care Med 2019;45(2):159–171. DOI: 10.1007/s00134-019-05519-y
Waterer G, Metersky ML. Corticosteroids for community-acquired pneumonia: overstated benefits and understated risks. Chest 2019;156(6):1049–1053. DOI: 10.1016/j.chest.2019.06.017
Aliberti S, Zanaboni AM, Wiemken T, et al. Criteria for clinical stability in hospitalised patients with community-acquired pneumonia. Eur Respir J 2013;42(3):742–749. DOI: 10.1183/09031936.00100812
Torres A, Sibila O, Ferrer M, et al. Effect of corticosteroids on treatment failure among hospitalized patients with severe community-acquired pneumonia and high inflammatory response: a randomized clinical trial. JAMA. 2015;313(7):677–686. DOI: 10.1001/jama.2015.88
Pitre T, Abdali D, Chaudhuri D, et al. Corticosteroids in community-acquired bacterial pneumonia: a systematic review, pairwise and dose-response meta-analysis. J Gen Intern Med 2023;38(11):2593–2606. DOI: 10.1007/s11606-023-08203-6
Dequin PF, Meziani F, Quenot JP, et al. Hydrocortisone in severe community-acquired pneumonia. N Engl J Med 2023;388(21):1931–1941. DOI: 10.1056/NEJMoa2215145
Townsend J, Adams V, Galiatsatos P, et al. Procalcitonin-guided antibiotic therapy reduces antibiotic use for lower respiratory tract infections in a United States Medical Center: results of a clinical trial. Open Forum Infect Dis 2018;5(12):ofy327. DOI: 10.1093/ofid/ofy327
Cilloniz C, Ferrer M, Liapikou A, et al. Acute respiratory distress syndrome in mechanically ventilated patients with community-acquired pneumonia. Eur Respir J 2018;51(3):1702215. DOI: 10.1183/13993003.02215-2017
Sligl WI, Marrie TJ. Severe community-acquired pneumonia. Crit Care Clin 2013;29(3):563–601. DOI: 10.1016/j.ccc.2013.03.009
Meduri GU, Shih MC, Bridges L, et al. Low-dose methylprednisolone treatment in critically ill patients with severe community-acquired pneumonia. Intensive Care Med 2022;48(8):1009–1023. DOI: 10.1007/s00134-022-06684-3
Snijders D, Daniels JMA, de Graaff CS, et al. Efficacy of corticosteroids in community-acquired pneumonia: a randomized double-blinded clinical trial. Am J Respir Crit Care Med 2010;181(9):975–982. DOI: 10.1164/rccm.200905-0808OC