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Adjunctive Therapeutic Treatment With Human Monoclonal Antibody AR-105 (Aerucin®) in P. Aeruginosa Pneumonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03027609
Recruitment Status : Completed
First Posted : January 23, 2017
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Aridis Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE January 17, 2017
First Posted Date  ICMJE January 23, 2017
Last Update Posted Date November 19, 2019
Actual Study Start Date  ICMJE March 29, 2017
Actual Primary Completion Date April 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2018)
Clinical Cure: treatment success, treatment failure [ Time Frame: 21 days following dosing ]
Clinical cure as adjudicated by committee
Original Primary Outcome Measures  ICMJE
 (submitted: January 18, 2017)
Clinical Cure: treatment success, treatment failure [ Time Frame: 4, 7, 14, 21 and 28 days following dosing ]
Clinical cure as adjudicated by committee
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2017)
  • Mortality, all-cause [ Time Frame: 28 days following dosing ]
  • Microbiological outcome: eradicated, not eradicated [ Time Frame: 28 days following dosing ]
  • Health Economic assessments: time ventilated, time in ICU, time in hospital [ Time Frame: 28 days following dosing ]
  • Safety - adverse events [ Time Frame: 28 days following dosing ]
  • Safety - immunogenicity [ Time Frame: 28 days following dosing ]
  • Pharmacokinetic: Aerucin blood level [ Time Frame: 28 days following dosing ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adjunctive Therapeutic Treatment With Human Monoclonal Antibody AR-105 (Aerucin®) in P. Aeruginosa Pneumonia
Official Title  ICMJE Placebo-controlled, Double-blind, Randomized Study of Aerucin® as Adjunct Therapy to Antibiotics in the Treatment of P. Aeruginosa Pneumonia
Brief Summary Prospective, double-blind, randomized assessment of the efficacy, safety and pharmacokinetic of Aerucin® as adjunct treatment (in addition to standard of care antibiotics) for pneumonia caused by P. aeruginosa.
Detailed Description This is a double-blind, randomized, placebo-controlled study of the human monoclonal antibody (mAb) AR-105 for the adjunctive therapeutic treatment of P. aeruginosa pneumonia in mechanically ventilated subjects. Subjects who are randomized will be treated with either standard of care (SOC) antibiotics plus placebo or SOC antibiotics plus AR-105. The study is being conducted at approximately 100 clinical sites across 17 countries. Subjects who meet all of the inclusion criteria and none of the exclusion criteria are screened by the microbiological culture test and/or rapid diagnostic test of an endotracheal aspirate to confirm the presence of an active P. aeruginosa infection. Following eligibility confirmation, the subject will be randomized in a 1:1 ratio to one of two treatment groups.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pseudomonas Aeruginosa Pneumonia
Intervention  ICMJE
  • Drug: AR-105
    monoclonal antibody
    Other Names:
    • Aerubumab
    • Aerucin
  • Drug: placebo
    matching placebo
Study Arms  ICMJE
  • Experimental: AR-105
    One intravenous infusion of AR-105 20mg/'kg
    Intervention: Drug: AR-105
  • Placebo Comparator: Control
    Matching placebo
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 8, 2019)
158
Original Estimated Enrollment  ICMJE
 (submitted: January 18, 2017)
108
Actual Study Completion Date  ICMJE April 25, 2019
Actual Primary Completion Date April 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Informed consent
  • ≥18 years of age, ≥ 20 years of age (Taiwan only),≥ 19 (S. Korea only)
  • pneumonia due to P. aeruginosa
  • ventilated
  • intubated
  • APACHE II score between 10 and 35

Exclusion Criteria (main criteria):

  • being moribund
  • effective antibiotic therapy ≥48 hours
  • immunocompromised
  • underlying pulmonary disease that may preclude the assessment of a therapeutic response
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belarus,   Belgium,   Czechia,   France,   Georgia,   Greece,   Hungary,   Korea, Republic of,   Mexico,   Peru,   Poland,   Russian Federation,   Spain,   Taiwan,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03027609
Other Study ID Numbers  ICMJE AR-105-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Aridis Pharmaceuticals, Inc.
Study Sponsor  ICMJE Aridis Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Bruno François, MD Hospital Dupuytren
PRS Account Aridis Pharmaceuticals, Inc.
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP