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Table 3 Characteristics of currently unpublished RCTs reported on ClinicalTrials.gov. website, comparing antimicrobials in the management of HAP/VAP

From: Treatment of severe hospital-acquired and ventilator-associated pneumonia: a systematic review of inclusion and judgment criteria used in randomized controlled trials

ClinicalTrial.gov identifier Investigational agent Comparator Name of the study Condition Primary outcome Definition of clinical cure Primary endpoint assessment timing Analyzed populations Current status of the study
NCT02714595 S-649266 Best available therapy CREDIBLE Severe infections due to carbapenem-resistant GNB including HCAP, HAP and VAP Clinical cure 1) Resolution or improvement of baseline signs of pneumonia Day 7 after EOT Not reported Recruiting
2) Improvement of chest radiography
3) No additional antibacterial therapy required for current infection treatment
NCT02070757 Ceftolozane/ Meropenem ASPECT-NP VAP or ventilated HAP All-cause mortality Not detailed Day 28 ITT Recruiting
Tazobactam
NCT01808092 Ceftazidime/ Meropenem REPROVE HAP/VAP Clinical cure 1) Patient alive Day 21 to day 25 after randomization Co-primary: Completed-has results
Avibactam 2) Resolution or improvement of all signs of pneumonia - clinically ITT
- clinically evaluable
NCT02452047 Imipenem Imipenem + cilastatin RESTORE-IMI 1 Severe infections due to Imipenem-resistant bacteria including HAP/VAP Favorable clinical success Not specified Up to day 28 Not reported Recruiting
+ Cilastatin/ +Colistimethate sodium
Relebactam  
NCT02493764 Imipenem Piperacillin/tazobactam RESTORE-IMI 2 HAP/VAP All-cause mortality Not specified Day 28 Not reported Recruiting
+Cilastatin/
Relebactam
NCT01970371 Plazomicin (+meropenem or tigecyclin) Colistin CARE Infections due to Carbapenem-resistant Enterobacteriaceae including HAP and VAP All-cause mortality Not specified Day 28 Not reported Completed
+Meropenem or Tigecyclin
NCT02168946 Meropenem Best available therapy Not reported Infections due to Carbapenem-resistant Enterobacteriaceae including HAP and VAP Clinical cure Resolution or improvement of the baseline signs and symptoms and no further antimicrobial warranted Days 12–23 Microbiological ITT Recruiting
Vaborbactam
NCT02019420 Tedizolid phosphate Linezolid MK-1986-002 Gram-positive HAP/VAP All-cause mortality Not specified Day 28 Microbiological ITT Recruiting
NCT02440828 Standard treatment + inhaled tobramycin Standard treatment + Placebo VAPORISE VAP Clinical response 1) Improvement of hypoxemia, After 72 hours of treatment Not reported Recruiting
2) Resolution of signs of sepsis
3) No worseming of chest radiography
NCT02478710 Standard treatment + inhaled tobramycin or inhaled vancomycin Standard treatment + Placebo AAINTVAP VAP Persistance/recurrence of pneumonia Not specified After 8 days of treatment/day 9 to day 21 Not reported Recruiting
NCT02728518 Standard treatment + nebulized amikacin Standard treatment + intravenous amikacin Not reported GNB-related VAP Clinical cure Not specified Not reported Not reported Completed
NCT02574130 Standard treatment + nebulized amikacin Standard treatment + placebo Not reported GNB-related VAP Clinical cure No worsening on chest radiography + improvement of leukocytosis and/or fever and/or tracheal secretion 10 days after treatment Not reported Recruiting
NCT01799993 Standard treatment + amikacin inhalation solution (BAY41-6551) Standard treatment + placebo INHALE-1 and 2 GNB-related mechanically ventilated pneumonia Clinical success Not specified 28–32 days after treatment initiation Modified ITT Recruiting
and
NCT00805168
  1. RCT randomized controlled trial, HAP hospital-acquired pneumonia, VAP ventilator-associated pneumonia, ITT intention-to-treat, GNB Gram-negative, HCAP Healthcare-associated pneumonia bacilli, EOT end of treatment