Pivotal Study in VAP Suspected or Confirmed to be Due to Pseudomonas Aeruginosa
| Status: | Recruiting |
|---|---|
| Conditions: | Pneumonia |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/7/2019 |
| Start Date: | March 23, 2018 |
| End Date: | July 2020 |
| Contact: | Polyphor Ltd |
| Email: | info@polyphor.com |
| Phone: | +41615671600 |
A Multicenter, Open-label, Randomized, Active-controlled, Parallel Group, Pivotal Study to Investigate the Efficacy, Safety and Tolerability, and Pharmacokinetics of Murepavadin Combined With One Anti-pseudomonal Antibiotic Versus Two Anti-pseudomonal Antibiotics in Adult Subjects With Ventilator-associated Bacterial Pneumonia Suspected or Confirmed to be Due to Pseudomonas Aeruginosa
This is a phase 3, multicenter, open-label, randomized active-controlled, parallel group to
investigate the efficacy, safety and tolerability, and pharmacokinetics of intravenous
murepavadin combined with of one anti-pseudononas antibiotic with that of two
anti-pseudomonas antibiotics in the treatment of ventilator-associated bacterial pneumonia
(VABP) in adult subjects.
investigate the efficacy, safety and tolerability, and pharmacokinetics of intravenous
murepavadin combined with of one anti-pseudononas antibiotic with that of two
anti-pseudomonas antibiotics in the treatment of ventilator-associated bacterial pneumonia
(VABP) in adult subjects.
Key Inclusion Criteria:
- Subject has received mechanical ventilation for at least 48h at the time of the
randomisation
- Acute Physiology and Chronic Health Evaluation (APACHE) of 8 to 30, inclusive, within
24h prior to randomization
- Presence of new or progressive infiltrate on chest X-ray
- Presence of clinical criteria consistent with VABP
- High probability of VABP caused by Pseudomonas aeriginosa
Key Exclusion Criteria:
- Known or suspected community-acquired bacterial pneumonia or viral, fungal, or
parasitic pneumonia
- Known hypersensitivity or contra-indications to beta-lactam antibiotics,
aminoglycosides, quinolones, colistin, or subjects with a clinically significant
history of anaphylactic reaction
- Severe liver or renal impairment
- Women who are pregnant or nursing, or who are of chilbearing potential and unwilling
to use acceptable method of birth control
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