Community-acquired pneumonia: multilobar: no clear benefit from filgrastim

Clinical bottom line (level 1b-)

  1. Patients with a multilobar pneumonia who received filgrastim compared with placebo were not clearly less likely to have a therapeutic failure or die.
Nelson et al: Journal of Infectious Diseases 2000; 182 : 970-973
Expires October 2003

The study

Double-blinded ?concealed randomised trial with intention-to-treat
Setting: 105 acute hospitals, USA, Canada, Australia

480 patients (aged 18 to 96; mean 62, 61% male) with a confirmed bacterial multilobar pneumonia and hypoxia, tachypnoea, and leukocytosis or relative leukopenia

Excluded if
  • received chemotherapy or radiotherapy or investigational drugs within previous month
  • unstable angina, congestive heart failure, myocardial infarction within previous 30 days
  • acute renal failure, shock, DIC, empyema
  • pregnant or breast-feeding
  • AIDS
  • acute respiratory distress syndrome
  • aged < 18
  • not on iv antibiotics
  • study drug not started within 24 hours of enrollment

    Control Group: (n = 243, analysed): placebo
    Experimental Group: (n = 237, analysed): filgrastim 300 microgram daily for 10 days or fewer, or until WBC > 75 x 10 9 /l, iv antibiotics discontinued or patient discharged from hospital

    100% followed for 30 days
    Outcome notes:
    • therapeutic failure : development of ARDS, DIC, ARF or shock; empyema; death

    The evidence

    Outcome Time to outcome CER EER RRR
    (95% CI)    		 ARR
    (95% CI)    		 NN T
    (95% CI)
    therapeutic failure 30 days 42
    (17.3%)    		 10
    (16.9%)    		 2%
    (-45% to 34%)    		 0.41%
    (-6.33% to 7.14%)    		 250
    (NNT = 14 to infinity;
    NNH = 16 to infinity)
    death 30 days 28
    (11.5%)    		 19
    (8.0%)    		 30%
    (-21% to 60%)    		 3.51%
    (-1.79% to 8.80%)    		 29
    (NNT = 11 to infinity;
    NNH = 56 to infinity)

    Comments

    1. The study was too small to exclude an important difference betweent the two groups.

    Citation

    1. Nelson S, Heyder AM, Stone J, et al: a randomized controlled trial of filgastrim for the treatment of hospitalized patients with multilobar pneumonia. Journal of Infectious Diseases 2000; 182 : 970-973
    Search Terms: from ACP Journal Club other articles ntoed
    Contributor: Chris Ball, October 2001
    Reviewer:

    Clinical Question.
    Patient multilobar community-acquired pneumonia
    Intervention or Exposure filgrastim
    Comparison placebo
    Outcome death, organ failure, empyema
    		•