PLACEBO-CONTROLLED, DOUBLE-BLIND, RANDOMIZED STUDY OF AERUCIN® AS ADJUNCT THERAPY TO ANTIBIOTICS IN THE TREATMENT OF P. AERUGINOSA PNEUMONIA

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

REPEC

Registry ID

PER-019-18

Enrollment

Registered

2018-10-17

Start date

2018-07-16

Completion date

Unknown

Last updated

2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Aerucin Type of group

Following randomization, study subjects will receive a single treatment dose (time 0 day 1) in addition to standard-of-care antibiotic treatment, and then enter a 27-day safety, efficacy and PK follow-up period for a total study duration of 28 days. Aerucin, 27.5 mg/ml in 4.5 ml (infusion solution)

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. Measure:Primary Clinical Efficacy Parameter Timepoints:28 days	—

Secondary

Measure	Time frame
Outcome name:1. Clinical cure: - Clinical cure rate at day 4, 7, 21 and 28. - Time to clinical cure. 2. Mortality All-cause mortality - Pneumonia-related mortality - Time to death over the 28-day follow-up period. 3. Respiratory function assessment: PaO2/FiO2 4. Overall clinical status: SOFA 5. Health economics and well-being: antibiotic utilization, duration of stay in the ICU, duration of hospitalization, ventilator-free days. Measure:Secondary Clinical Efficacy Parameters Timepoints:28 days	—

Measure

Time frame

Outcome name:1. Clinical cure: - Clinical cure rate at day 4, 7, 21 and 28. - Time to clinical cure. 2. Mortality All-cause mortality - Pneumonia-related mortality - Time to death over the 28-day follow-up period. 3. Respiratory function assessment: PaO2/FiO2 4. Overall clinical status: SOFA 5. Health economics and well-being: antibiotic utilization, duration of stay in the ICU, duration of hospitalization, ventilator-free days. Measure:Secondary Clinical Efficacy Parameters Timepoints:28 days

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Countries

Belgium, Czech Republic, France, Germany, Greece, Hungary, Italy, Korea South, Mexico, Peru, Poland, Russian Federation, Spain, Taiwan, United Kindgdom, United States

Contacts

Public ContactAndrea Ysela Escala

GOTUZZO ASOCIADOS S.A.C.

aescala@gotuzzos.com2422878

Outcome results