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The Effectiveness of Beta-lactam Monotherapy, Beta-lactam and Macrolide Combination Therapy or Fluoroquinolone Monotherapy in Patients Hospitalized with Community-Acquired Pneumonia: a Cluster-Randomized Cross-Over Trial

Session: Poster Abstract Session: Approach to Clinical Infections
Friday, October 10, 2014
Room: The Pennsylvania Convention Center: IDExpo Hall BC
  • poster_capstart_results_idweek_021014.pdf (555.9 kB)
  • Background: Optimal empirical treatment for community-acquired pneumonia is unknown. We compared empirical treatment strategies of beta-lactam monotherapy (BL), beta-lactam/macrolide combination (BLM) and fluoroquinolone monotherapy (FQL) in hospitalized community-acquired pneumonia (CAP).

    Methods: A cluster-randomized cross-over trial was performed in seven Dutch hospitals. CAP patients initially admitted to a non-ICU ward and treated with antibiotics were eligible, independent of antibiotics chosen. Deviations for medical reasons were allowed and were considered per protocol treatment. The primary endpoint was 90-day mortality, with a non-inferiority margin of 3%. Secondary endpoints were time to oral treatment and length of stay. Intention-to-treat (ITT), per-protocol (PP) and on-treatment (OT) analyses were performed. All analyses were adjusted for cluster-period effects and confounders.

    Results: Of 3,325 eligible patients, 656, 739 and 888 patients were included in the BL, BLM and FQL periods, respectively. Protocol adherence was 94%, 88%, and 93%, and 71%, 73% and 80% of patients received the preferred antibiotic class in the respective periods. Baseline characteristics did not differ between study periods. Crude 90-day mortality rates were 9.0% (n=59), 11.1% (n=82), and 8.8% (n=78) in the BL, BLM, and FQL periods, respectively. BL was non-inferior to BLM and FQL for day-90 mortality, except for FQL in OT analysis compared to FQL (Figure 1). Median (IQR) length of stay was 6 (4-8), 6 (4-10) and 6 (4-8) for BL, BLM and FQL, respectively. BLM was associated with a longer length of stay (Figure 2). Median (IQR) duration of IV treatment was 4 (3-5), 4 (3-5) and 3 (0-4) in the respective periods. FQL was associated with a shorter duration of IV treatment (Figure 3), however, this did not result in a shorter length of stay.

    Conclusion: A strategy of preferred empirical treatment with BL for patients hospitalized with CAP to non-ICU wards was non-inferior to BLM or FQL strategies for 90-day mortality. BLM was associated with a longer length of stay, and FQL with a shorter duration of IV treatment.

    Figure 1: absolute risk differences in 90-day mortality

    Figure 2: hazard ratios for length of stay

    Figure 3: hazard ratios for time to oral treatment

    Douwe F. Postma, MD1, Cornelis H Van Werkhoven, MD1, Jan Jelrik Oosterheert, MD, PhD2 and Marc Bonten, MD PhD3, (1)Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands, (2)University Medical Center Utrecht, Utrecht, Netherlands, (3)Department of Medical Microbiology, University Medical Center Utrecht, Utrecht, Netherlands


    D. F. Postma, None

    C. H. Van Werkhoven, None

    J. J. Oosterheert, None

    M. Bonten, None

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