Abstract & Commentary
Synopsis: In selected patients with community-acquired pneumonia, outpatient treatment with levofloxacin was as safe and effective as hospitalization.
Source: Catarrala J, et al. Ann Intern Med. 2005;142: 165-172.
This study was aimed at evaluating whether outpatient care of pneumonia-severity-index (PSI) low-risk patients with community-acquired pneumonia (CAP) was as safe and effective as hospitalization. It was designed as an unblinded, randomized, controlled trial over a 2-year period of time at 2 tertiary care hospitals in Barcelona, Spain. Those immunocompetent patients who were at least 18 years of age and that received the diagnosis of CAP in the emergency department were eligible for inclusion. Patients with neutropenia, HIV infection, transplantation, splenectomy or those who were taking immunosuppressive drugs were excluded from the trial. CAP was defined as the presence of a new infiltrate on chest radiograph plus at least one of the following: fever (temperature > 38.0°C) or hypothermia (temperature < 35.0°C), new cough with or without sputum production, pleuritic chest pain, dyspnea, or altered breath sounds on auscultation.
Patients with CAP were stratified into PSI risk classes. Those patients in risk classes I, IV, and V were excluded as well as those patients who were pregnant, those with allergy to fluorquinolones, concomitant comorbid conditions necessitating hospitalization for treatment, complicated pleural effusions, respiratory failure or severe social problems precluding adequate outpatient treatment. The primary end point of the trial was the percentage of patients with an overall successful outcome, defined as meeting all 7 predefined criteria: cure of pneumonia, absence of medical complications during treatment, no need for additional visits, no changes in the initial treatment, absence of subsequent hospital admission in the 30 days after randomization, and absence of death from any cause in the 30 days after randomization.
A total of 224 patients were randomly assigned and included in an intention-to-treat analysis for the primary end point. Of these, 110 received outpatient care and 114 were hospitalized. Outpatients were treated with oral levofloxacin for 10.19 ± 1.97 days.
Inpatients received intravenous therapy with levofloxacin for 2.25 ± 0.94 days before switching to oral levofloxacin. Mean length of hospitalization was 5.1 ± 2.07 days and a total length of antibiotic therapy of 10.00 ± 2.56 days. 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). Subsequent hospital admissions and overall mortality were similar in the outpatient and hospitalization groups. In addition, in a follow up survey, more outpatients were more satisfied with their overall care than hospitalized patients.
Comment by Joseph Varon, MD, FACP, FCCP, FCCM
CAP accounts for 10 million physician office visits each year in the United States. The estimated cost of an episode of CAP for hospitalized patients is $6,000 to $7,000 dollars as compared with less than $200 for outpatient treatment. Clinicians are often confronted with the decision as to whether or not to admit these patients to the hospital. Clinical prediction guidelines and severity scoring systems have been developed in an attempt to predict the outcome of patients with CAP.1,2
The study by Carratala and associates is important as it presents interesting and compelling data about the safety and efficacy favoring outpatient care for selected low-risk patients with CAP.3 According to their results, patients in PSI risk classes II and III can be safely treated with levofloxacin as outpatients in the absence of respiratory failure, complicated pleural effusions or social problems compromising outpatient care.
In an era of cost-containment and resource constrains, adequate resource allocation is of extreme importance. Therefore, the findings by Carratala et al have significant economic implications. Clinicians caring for patients with low risk CAP must individually consider each patient and based on the results of this study, consider outpatient therapy in selected patients as long as close follow up is available.
Dr. Varon, Professor, University of Texas Health Science Center; St. Luke’s Episcopal Hospital, Houston, TX, is Associate Editor of Internal Medicine Alert.
1. Niederman MS, et al. Am J Respir Crit Care Med. 2001;1634:1730-1754.
2. Fine MJ, et al. JAMA. 1996;275:134-141.
3. Carratala J, et al. Ann Intern Med. 2005;142:165-172.