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Table 2 Clinical and microbiological cure criteria, and adverse events assessment in included studies

From: Nebulized antibiotics for ventilator-associated pneumonia: a systematic review and meta-analysis

Study, year

Clinical cure criteria

Microbiological cure criteria

Adverse events assessed

Observational studies

   

 Doshi, 2013 [21]

Resolution of initial signs and symptoms of infection, including normalization of white blood cell count and temperature, by the end of therapy.

Eradication of the MDR pathogen on subsequent respiratory cultures

NA

 Ghannam, 2009 [22]

Improved clinical parameters (fever defervescence, suctioning requirements, symptoms and signs of pneumonia), ventilator parameters and laboratory findings (improved blood gases, normalization of white blood cell count), and/or receding pulmonary infiltrates on a chest radiograph at the end of therapy.

Eradication of causative organisms in patients in whom a follow-up culture was obtained at the end of therapy.

Renal dysfunction (doubling of serum creatinine in patients with pretreatment (baseline) creatinine clearance of ≥30 ml/minute or an increase in creatinine by ≥1 mg/dl at the end of therapy in patients with pretreatment creatinine clearance <30 ml/minute)

 Kalin, 2012 [23]

Resolution of symptoms and signs of VAP at the end of the therapy

Eradication of MDR A. baumannii on follow-up culture

Renal toxicity (RIFLE criteria)

 Kofteridis, 2010 [24]

Resolution of presenting symptoms and signs of infection by the end of colistin treatment

Eradication of the pathogen at the end of antimicrobial therapy or at discharge from ICU

Renal toxicity (serum creatinine value >2 mg/dl; reduction in the calculated creatinine clearance of 50%, compared with the value at the start of treatment; or as a decline in renal function that prompted renal replacement therapy; increase of 150% of the baseline creatinine, a reduction in the calculated creatinine clearance of 50% relative to the value at therapy initiation in patients with pre-existing renal dysfunction), bronchoconstriction, cough, apnea, or chest tightness, and arterial hypoxemia.

 Korbila, 2010 [29]

Normalization of temperature and tracheal secretions, together with a return to baseline of the white blood cell count and the C-reactive protein level, and the improvement in chest X-ray appearances, by the end of treatment.

NA

NA

 Tumbarello, 2013 [31]

Resolution of all signs and symptoms of pneumonia and improvement or lack of progression of all chest radiograph abnormalities when colistin was discontinued

Disappearance of the infecting bacterium from post-treatment respiratory samples

Acute kidney injury (a greater than twofold increase in serum creatinine or a ≥50% decrease in the glomerular filtration rate or oliguria (output <0.5 ml/kg/hour) for ≥12 hours)

Randomized controlled trials

  

 Hallal, 2007 [25]

Extubation within the study period, improving of MODS, resolution of fever, pulmonary infiltrates and physical signs of pneumonia.

NA

Doubling of the serum creatinine concentration or an increase of creatinine above 2 mg/dl at any timea

 Le Conte, 2000 [26]

Extubation within 10 days

NA

Respiratory tolerance (described in results section as hypoxemia during nebulization) and evolution of serum creatinine

 Lu, 2011 [27]

Reduction of clinical and biological signs of infection, decrease in modified clinical pulmonary infection score below 6, significant lung CT re-aeration, and lower respiratory tract specimens either sterile or with nonsignificant concentrations of P. aeruginosa

Eradication of P. aeruginosa in a lower respiratory specimens after 8 days of antimicrobial therapy

Bronchospasm, hypoxemia, obstruction of expiratory filter

 Niederman, 2012 [28]

Complete or partial resolution of signs and symptoms of pneumonia, improvement or lack of progression of abnormalities on chest X-ray, and no additional intravenous antibiotics since completion of treatment

Confirmed eradication of the original pathogen or presumed eradication in patients with complete or partial resolution of pneumonia

Septic shock, seizures and bronchospasm.

 Palmer, 2014 [30]

NA

No growth in culture and no visible organisms seen on Gram-stain of an organism identified at randomization

New resistant to antimicrobial therapy

 Rattanaumpawan, 2010 [32]

Complete resolution of all signs and symptoms of pneumonia, and improvement or lack of progression of all abnormalities on the chest radiograph

Eradication or presumed eradication after antimicrobial treatment

Renal impairment (a rise of 2 mg/dl in the serum creatinine level of patients with previously normal renal function or a doubling of the baseline serum creatinine level in patients with pre-existing renal insufficiency), bronchospasm.

  1. aThis was among the definitions of treatment failure in the trial. CT, computed tomography; MDR, multidrug resistant; MODS, multiple organ dysfunction score; NA, not available; RIFLE, Risk, Injury, Failure, Loss, and End-stage kidney disease; VAP, ventilator-associated pneumonia.