Table 3 Characteristics of currently unpublished RCTs reported on ClinicalTrials.gov.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