title: Prospective open-label randomized comparative, non-inferiority study of two initial antibiotic strategies for patients with nursing- and healthcare-associated pneumonia: Guideline-concordant therapy versus empiric therapy.
abstract: OBJECTIVE
  The nursing- and healthcare-associated pneumonia guideline, proposed by the Japan Respiratory Society, recommends that patients at risk of exposure to drug-resistant pathogens, classified as treatment category C, be treated with antipseudomonal antibiotics. This study aimed to prove the non-inferiority of empirical therapy in our hospital compared with guideline-concordant therapy.
  
  
  METHODS
  This was a randomized controlled trial conducted from December 2011 to December 2012. Patients were randomized to the Guideline group receiving guideline-concordant therapy, and the Empiric group treated with sulbactam/ampicillin or ceftriaxone. The primary endpoint was in-hospital relapse of pneumonia and mortality within 30 days, with a predefined non-inferiority margin of 10%. The secondary endpoints included duration, adverse effects, and cost of antibiotic therapy.
  
  
  RESULTS
  One hundred and eleven patients were assigned to the Guideline group (n = 55) and the Empiric group (n = 56; 3 of which were excluded). The incidence of relapse and death within 30 days was similar in the Guideline and the Empiric groups (31% vs. 26%, risk difference -4.5%, 95% CI -21.5% to 12.5%). While the duration of antibiotic therapy was slightly shorter in the Guideline group than in the Empiric group (7 vs. 8 days), there were no significant differences in adverse effects or cost.
  
  
  CONCLUSIONS
  The efficacy of empiric therapy was comparable to guideline-concordant therapy, although non-inferiority was not proven. The administration of broad-spectrum antibiotics to patients at risk of exposure to drug-resistant pathogens may not necessarily improve the prognosis.
  
  
  BACKGROUND
  UMIN000006792.
authors.affiliation: Department of Respiratory Medicine, Hamamatsu Medical Center, Japan; Respiratory Disease Center, Fukujuji Hospital, Japan Anti-tuberculosis Association, Japan. Electronic address: elliptical-full.shuichi@nifty.com.
authors.forename: Shuichi
authors.initials: S
authors.lastname: Matsuda
authors.affiliation: Department of Respiratory Medicine, Hamamatsu Medical Center, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Ogasawara
authors.affiliation: Department of Respiratory Medicine, Hamamatsu Medical Center, Japan; Department of Respiratory Medicine, Chiba University Hospital, Japan.
authors.forename: Shunsuke
authors.initials: S
authors.lastname: Sugimoto
authors.affiliation: Department of Respiratory Medicine, Hamamatsu Medical Center, Japan; Respiratory Medicine, Second Division, Department of Internal Medicine, Graduate School of Medicine, Hamamatsu University, Japan.
authors.forename: Shinpei
authors.initials: S
authors.lastname: Kato
authors.affiliation: Department of Respiratory Medicine, Hamamatsu Medical Center, Japan; Department of Respirology, Graduate School of Medicine, Chiba University, Japan.
authors.forename: Hiroki
authors.initials: H
authors.lastname: Umezawa
authors.affiliation: Department of Respiratory Medicine, Hamamatsu Medical Center, Japan.
authors.forename: Toshiaki
authors.initials: T
authors.lastname: Yano
authors.affiliation: Department of Respiratory Medicine, Hamamatsu Medical Center, Japan.
authors.forename: Norio
authors.initials: N
authors.lastname: Kasamatsu
mesh_terms: D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D017714:Community-Acquired Infections / Q000188:drug therapy; D024881:Drug Resistance, Bacterial; D005260:Female; D019983:Guideline Adherence / Q000191:economics; D006801:Humans; D017758:Infectious Disease Transmission, Patient-to-Professional / Q000517:prevention & control*; D008297:Male; D009729:Nursing; D018410:Pneumonia, Bacterial / Q000188:drug therapy* / Q000382:microbiology / Q000401:mortality / Q000451:nursing*; D017410:Practice Guidelines as Topic; D057184:Practice Patterns, Nurses'; D011379:Prognosis; D011446:Prospective Studies; D012008:Recurrence; D012307:Risk Factors
chemical_list: D000900:Anti-Bacterial Agents
keywords: Antibiotic therapy; Nursing- and healthcare-associated pneumonia; Prognosis; Randomized controlled trial; Risk factor