The purpose of this study is to learn if an experimental antibiotic called TR- 701 FA can safely and effectively treat ventilated patients with hospitalacquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia. The experimental antibiotic will be tested against the already approved antibiotic Linezolid. The sponsor of the study wants to prove, that the new medication isn't inferior regarding efficacy and safety as compared to the already approved medication Linezolid.

Phase 1

• Conditions: Ventilated Gram-positive nosocomial pneumonia; MedDRA version: 20.1 Level: LLT Classification code 10052596 Term: Nosocomial pneumonia System Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2013-004154-22-IT
• Lead Sponsor: CUBIST PHARMACEUTICALS INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-27
• Study Completion: 2018-06-22
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 726

Inclusion Criteria

Patients who meet all the following diagnostic and inclusion criteria are
eligible for the study.
1. Males or females = 18 years old
2. Adequate venous access for IV study drug administration
3. Intubated (via endotracheal tube, including tracheostomy patients)
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and mechanically ventilated, AND
• For HABP, at least 1 of the following signs or symptoms presenting
within 24 hours prior to intubation of a patient hospitalized, including
patients institutionalized in long-term care facilities, for =48 hours. If
the patient has been discharged, discharge must have been within 7
days:
o A new onset of cough (or worsening of baseline cough)
o Dyspnea, tachypnea, or respiratory rate >30/minute, particularly if
any or all of these signs or symptoms are progressive in nature
o Hypoxemia (eg, a partial pressure of oxygen <60 mm Hg while the
patient is breathing on room air as determined by arterial blood gas
(ABG) or oxygen saturation <90% while the patient is breathing on
room air as determined by pulse oximetry, or worsening (decline from
any earlier finding) of the ratio of the partial pressure of oxygen to the
fraction of inspired oxygen (PaO2/FiO2), or respiratory failure requiring
mechanical ventilation
• For VABP, receiving mechanical ventilation =48 hours:
Acute changes made in the ventilator support system to enhance
oxygenation, as determined by ABG, or worsening PaO2/FiO2
4. Chest radiograph shows the presence of new or progressive
infiltrate(s) suggestive of bacterial pneumonia (based on Investigator
evaluation; report from qualified medical professional who is not the
Investigator to be provided) 5. Clinical findings to support diagnosis of HABP/VABP
• New onset of suctioned respiratory secretions characterized by
purulent appearance indicative of bacterial pneumonia
• And at least 1 of the following:
o Documented fever (oral =38°C [100.4°F] or a tympanic, temporal,
rectal, or core temperature =38.3°C [101°F]) OR
o Hypothermia (core body temperature =35°C [95.2°F]) OR
o Total peripheral white blood cell (WBC) count =10,000 cells/mm3 OR
o Leukopenia with total WBC =4500 cells/mm3 OR
o =15% immature neutrophils (bands; if local laboratory has
capabilities to measure)
6. High probability of pneumonia caused by gram-positive cocci only or
in a mixed infection defined as follows:
Respiratory Sample
o Sample acquired and Gram stain performed within 24 hours prior to
first infusion of study drug using an acceptable purulent respiratory
specimen such as sputum or endotracheal aspirate sample with <10
squamous epithelial cells (SEC) per low-power field and more than 25
polymorphonuclear cells per low-power field showing gram-posit

Exclusion Criteria

Patients who meet any of the following criteria are not eligible to
participate in this study:
1. Known or suspected community-acquired bacterial pneumonia or
viral, fungal, or parasitic pneumonia
2. Any of the following health conditions:
• Legionella infection (Legionella pneumophila pneumonia)
• Cystic fibrosis
• Bronchiectasis
• Human immunodeficiency virus (HIV) infection with last known CD4
count <200 cell/mm³ (HIV testing is not required)
• Known or suspected Pneumocystitis jiroveci pneumonia
• Known or suspected active tuberculosis
• Lung abscess
• Evidence of endocarditis
• Tracheobronchitis (if no evidence of pneumonia)
3. Received systemic or inhaled antibiotic therapy effective for grampositive
pathogens that cause VNP for >24 hours (for example, >1 dose
of a once-daily antibiotic, >2 doses of a twice daily antibiotic) in the last
72 hours
EXCEPTIONS
• Progression of disease on the prior antibacterial regimen for this
episode of VNP after >48 hours of treatment; requires microbiological
confirmation of a gram-positive pathogen,
OR
• Patient developed symptoms of pneumonia and a new infiltrate while
receiving the prior antibacterial regimen for reasons other than the
current VNP,
OR
• Patient received systemic antibacterial therapy that does not cover the
gram positive pathogen isolated on respiratory culture,
OR
• Antibiotic therapy for gut decontamination or gut motility (example,
low-dose erythromycin) or C. difficile infection
4. Receipt of monoamine oxidase A and B inhibitors (see Appendix 1)
from 2 weeks prior to randomization or planned use through the End of
Therapy (EOT) Visit
5. Planned use of agents with serotonergic activity (see Appendix 1 and
Section 1.4) through the EOT Visit
6. Administration of linezolid or tedizolid phosphate =30 days before the
first infusion of study drug, except for receipt of a single administration
of linezolid, within 24 hours prior to the first administration of study
drug to treat the current VNP.
7. Bronchial obstruction or a history of postobstructive pneumonia (this
does not exclude patients with pneumonia who have underlying chronic
obstructive pulmonary disease)
8. Primary lung cancer or another malignancy metastatic to the lungs
9. Recent opportunistic infections where the underlying cause of the
infection is still active (eg, leukemia, transplant, acquired
immunodeficiency syndrome) 10. Expected survival <72 hours or any 1 of the following:
• Comfort care measures only
• Acute respiratory distress syndrome/acute lung injury secondary to
septic shock, or due to third degree burns or inhalation injury
• Nonresolving pulmonary edema secondary to c

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified