A

Not Applicable

Recruiting

• Conditions: -J15; J15

• Registration Number: PER-002-14
• Lead Sponsor: Cubist Pharmaceuticals LLC.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-16
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

1.Males or females ≥18 years old
2. Adequate venous access for IV study drug administration
3. Intubated (via endotracheal tube, including tracheostomy patients) 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

Exclusion Criteria

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 CD4 count
<200 cell/mm³ (HIV testing is not required)
• Known or suspected Pneumocystitis jiroveci pneumonia
• Known or suspected active tuberculosis
• Lung abscess
• Empyema
• Evidence of endocarditis
• Tracheobronchitis

Study & Design

• Study Type: Interventional
• Study Design: Not specified