Outpatient Care Compared with Hospitalization for Community-Acquired Pneumonia

A Randomized Trial in Low-Risk Patients

  1. Jordi Carratalà, MD;
  2. Núria Fernández-Sabé, MD;
  3. Lucía Ortega, MD;
  4. Xavier Castellsagué, MD;
  5. Beatriz Rosón, MD;
  6. Jordi Dorca, MD;
  7. Ana Fernández-Agüera, RN;
  8. Ricard Verdaguer, MD;
  9. Joaquín Martínez, MD;
  10. Frederic Manresa, MD; and
  11. Francesc Gudiol, MD
  1. From IDIBELL-Hospital Universitari de Bellvitge, University of Barcelona, and SCIAS-Hospital de Barcelona, Barcelona, Spain.

    Abstract

    Background: The Pneumonia Severity Index (PSI) has been advocated as an objective measure of risk stratification to help determine the initial site of treatment for patients with community-acquired pneumonia.

    Objective: To determine whether outpatient care of PSI-defined low-risk patients with community-acquired pneumonia is as safe and effective as hospitalization.

    Design: Unblinded, randomized, controlled trial.

    Setting: 2 tertiary care hospitals.

    Patients: 224 immunocompetent adults in risk class II or III (PSI scores ≤90 points) who received a diagnosis of community-acquired pneumonia in the emergency department and had no extenuating circumstances.

    Intervention: Outpatient care with oral levofloxacin therapy or hospitalization with sequential intravenous and oral levofloxacin therapy.

    Measurements: The primary end point was the percentage of patients with an overall successful outcome at the end of treatment, according to 7 predefined criteria. Secondary end points included patients' quality of life and satisfaction.

    Results: Overall successful outcome was achieved in 83.6% of outpatients and 80.7% of hospitalized patients (absolute difference, 2.9 percentage points [95% CI, −7.1 to 12.9 percentage points]). More outpatients were satisfied with their overall care (91.2% vs. 79.1%; absolute difference, 12.1 percentage points [CI, 1.8 to 22.5 percentage points]). Quality of life and the percentages of patients with adverse drug reactions (9.1% vs. 9.6%), medical complications (0.9% vs. 2.6%), subsequent hospital admissions (6.3% vs. 7.0%), and overall mortality (0.9% vs. 0%) were similar in the outpatient and hospitalization groups.

    Limitations: The power to detect a serious complication, such as death, was limited given the relatively small sample size.

    Conclusions: In selected patients who had community-acquired pneumonia, PSI risk class II and III, and were treated with levofloxacin, outpatient care in the absence of respiratory failure, unstable comorbid conditions, complicated pleural effusions, and social problems was as safe and effective as hospitalization and provided greater patient satisfaction.

    Article and Author Information

    • Trial ISRCTN41238928.

    • Acknowledgments: The authors thank Ginesa Albero for data management and statistical analyses and Dr. Tom Gottlieb for his review of the manuscript. They also thank the staff members and residents of the Infectious Disease, Respiratory, Internal Medicine, and Emergency Medicine Services of the IDIBELL-Hospital Universitari de Bellvitge and the SCIAS-Hospital de Barcelona for their valuable cooperation.

    • Grant Support: By research grants from the Spanish National Health Service (FIS 00/0438) and from Aventis, Madrid, Spain. Dr. Fernández-Sabé is the recipient of a fellowship grant from the University of Barcelona, Barcelona, Spain.

    • Potential Financial Conflicts of Interest: Honoraria: J. Dorca (Aventis), F. Gudiol (Aventis); Grants received: F. Gudiol (Aventis).

    • Requests for Single Reprints: Jordi Carratalà, MD, Infectious Disease Service, Hospital Universitari de Bellvitge, Feixa Llarga s/n, L'Hospitalet de Llobregat, 08907 Barcelona, Spain; e-mail, jcarratala{at}wanadoo.es.

    • Current Author Addresses: Drs. Carratalà, Fernández-Sabé, Rosón, and Gudiol and Miss Fernández-Agüera: Infectious Disease Service, Hospital Universitari de Bellvitge, Feixa Llarga s/n, L'Hospitalet de Llobregat, 08907 Barcelona, Spain.

    • Drs. Ortega and Martínez: Internal Medicine Service, SCIAS-Hospital de Barcelona, Diagonal 660, 08034 Barcelona, Spain.

    • Dr. Castellsagué: Cancer Epidemiology and Registration Unit, Institut Català d'Oncologia, Gran Via s/n, Km 2.7, L'Hospitalet de Llobregat, 08907 Barcelona, Spain.

    • Drs. Dorca and Manresa: Respiratory Medicine Service, Hospital Universitari de Bellvitge, Feixa Llarga s/n, L'Hospitalet de Llobregat, 08907 Barcelona, Spain.

    • Dr. Verdaguer: Microbiology Service, Hospital Universitari de Bellvitge, Feixa Llarga s/n, L'Hospitalet de Llobregat, 08907 Barcelona, Spain.

    • Author Contributions: Conception and design: J. Carratalà, F. Gudiol.

    • Analysis and interpretation of the data: J. Carratalà, N. Fernández-Sabé, L. Ortega, X. Castellsagué, B. Rosón, J. Dorca, A. Fernández-Agüera, R. Verdaguer, J. Martínez, F. Manresa, F. Gudiol.

    • Drafting of the article: J. Carratalà, N. Fernández-Sabé, X. Castellsagué, F. Gudiol.

    • Critical revision of the article for important intellectual content: J. Carratalà, N. Fernández-Sabé, L. Ortega, X. Castellsagué, B. Rosón, J. Dorca, A. Fernández-Agüera, R. Verdaguer, J. Martínez, F. Manresa, F. Gudiol.

    • Final approval of the article: J. Carratalà, N. Fernández-Sabé, L. Ortega, X. Castellsagué, J. Dorca, A. Fernández-Agüera, R. Verdaguer, J. Martínez, F. Manresa, F. Gudiol.

    • Provision of study materials or patients: J. Carratalà, N. Fernández-Sabé, L. Ortega.

    • Statistical expertise: X. Castellsagué, B. Rosón.

    • Obtaining of funding: J. Carratalà, F. Gudiol.

    • Collection and assembly of data: J. Carratalà, N. Fernández-Sabé, L. Ortega, B. Rosón, J. Dorca, A. Fernández-Agüera, R. Verdaguer, J. Martínez, F. Manresa, F. Gudiol.

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