PLACEBO-CONTROLLED, DOUBLE-BLIND, RANDOMIZED STUDY OF AERUCIN® ASADJUNCT THERAPY TO ANTIBIOTICS IN THE TREATMENT OF P. AERUGINOSAPNEUMONIA
Not Applicable
- Conditions
- -J151 Pneumonia due to PseudomonasPneumonia due to PseudomonasJ151
- Registration Number
- PER-019-18
- Lead Sponsor
- Aridis Pharmaceuticals, Inc,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Written Informed Consent given by the patient or, if not possible, by a legally authorized representative and/or an independent physician as authorized by the competent ethics committee (EC) or independent review board (IRB) and local regulations.
2. Diagnosis of pneumonia based on the following criteria:see protocol, pg 6
Exclusion Criteria
1. The subject is moribund.
2. Effective antibacterial drug therapy for the index pneumonia administered continuously for 48 hours or more prior to initiation of study treatment.
For further criteria, see protocol pg 7
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Clinical cure, i.e., resolution of the pneumonia event diagnosed at enrollment. Clinical cure” is resolution of pneumonia as determined by an independent adjudication committee based on objective criteria. Clinical cure at day 14 will be used as primary clinical efficacy parameter.<br>Measure:Primary Clinical Efficacy Parameter<br>Timepoints:28 days<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:1. Clinical cure:<br>- Clinical cure rate at day 4, 7, 21 and 28.<br>- Time to clinical cure.<br><br>2. Mortality<br>All-cause mortality<br>- Pneumonia-related mortality<br>- Time to death over the 28-day follow-up period.<br><br>3. Respiratory function assessment: PaO2/FiO2<br>4. Overall clinical status: SOFA<br>5. Health economics and well-being: antibiotic utilization, duration of stay in the ICU, duration of hospitalization, ventilator-free days.<br>Measure:Secondary Clinical Efficacy Parameters<br>Timepoints:28 days<br>