Adjunctive Therapeutic Treatment With Human Monoclonal Antibody AR-105 (Aerucin®) in P. Aeruginosa Pneumonia
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|ClinicalTrials.gov Identifier: NCT03027609|
Recruitment Status : Active, not recruiting
First Posted : January 23, 2017
Last Update Posted : April 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pseudomonas Aeruginosa Pneumonia||Drug: AR-105 Drug: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||154 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Placebo-controlled, Double-blind, Randomized Study of Aerucin® as Adjunct Therapy to Antibiotics in the Treatment of P. Aeruginosa Pneumonia|
|Actual Study Start Date :||March 29, 2017|
|Estimated Primary Completion Date :||April 28, 2019|
|Estimated Study Completion Date :||April 28, 2019|
One intravenous infusion of AR-105 20mg/'kg
Placebo Comparator: Control
- Clinical Cure: treatment success, treatment failure [ Time Frame: 21 days following dosing ]Clinical cure as adjudicated by committee
- Mortality, all-cause, the difference in the number of patients who die with Standard of Care (SOC) alone and AR-105 plus SOC [ Time Frame: 28 days following dosing ]Difference in mortality defined as cause of death between Standard of Care (SOC) alone or with AR-105.
- Microbiological outcome: eradicated, not eradicated [ Time Frame: 28 days following dosing ]Eradication/non-eradication of P. aeruginosa in microbiological cultures.
- Health Economics assessments: time ventilated, time in ICU, time in the hospital [ Time Frame: 28 days following dosing ]Number of days ventilation, in the ICU and in the hospital.
- Safety - adverse events [ Time Frame: 28 days following dosing ]Number of treatment-emergent adverse events assessed by the Principal Investigator.
- Safety - immunogenicity, concentration of anti-drug antibody [ Time Frame: 28 days following dosing ]Assess the immunogenicity of AR-105
- Pharmacokinetic: AR-105 blood level [ Time Frame: 28 days following dosing ]Amount of AR-105 in the blood over time
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03027609
|United States, Florida|
|Jacksonville, Florida, United States, 32209|
|United States, Missouri|
|Saint Louis, Missouri, United States, 63110|
|United States, Ohio|
|Columbus, Ohio, United States, 43215|
|Study Chair:||Bruno François, MD||Hospital Dupuytren|