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

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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.


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
We found this trial at
4
sites
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Springfield, MO
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Belo Horizonte,
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Belo Horizonte,
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Chicago, IL
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Greensboro, North Carolina 27401
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Greensboro, NC
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