Status:
TERMINATED
Pivotal Study in VAP Suspected or Confirmed to be Due to Pseudomonas Aeruginosa
Lead Sponsor:
Polyphor Ltd.
Conditions:
Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
March 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2019
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT03409679
Start Date
March 23 2018
End Date
July 17 2019
Last Update
August 28 2019
Active Locations (61)
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1
Research site
Chicago, Illinois, United States, 60208
2
Research site
Springfield, Missouri, United States, 65802
3
Research site
Greensboro, North Carolina, United States, 27403
4
Research Site 1
Belo Horizonte, Brazil