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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 : Active, not recruiting
First Posted : January 23, 2017
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Aridis Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Pseudomonas Aeruginosa Pneumonia Drug: AR-105 Drug: placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: AR-105
One intravenous infusion of AR-105 20mg/'kg
Drug: AR-105
monoclonal antibody
Other Names:
  • Aerubumab
  • Aerucin

Placebo Comparator: Control
Matching placebo
Drug: placebo
matching placebo




Primary Outcome Measures :
  1. Clinical Cure: treatment success, treatment failure [ Time Frame: 21 days following dosing ]
    Clinical cure as adjudicated by committee


Secondary Outcome Measures :
  1. 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.

  2. Microbiological outcome: eradicated, not eradicated [ Time Frame: 28 days following dosing ]
    Eradication/non-eradication of P. aeruginosa in microbiological cultures.

  3. 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.

  4. Safety - adverse events [ Time Frame: 28 days following dosing ]
    Number of treatment-emergent adverse events assessed by the Principal Investigator.

  5. Safety - immunogenicity, concentration of anti-drug antibody [ Time Frame: 28 days following dosing ]
    Assess the immunogenicity of AR-105

  6. Pharmacokinetic: AR-105 blood level [ Time Frame: 28 days following dosing ]
    Amount of AR-105 in the blood over time



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Florida
Research Site
Jacksonville, Florida, United States, 32209
United States, Missouri
Research Site
Saint Louis, Missouri, United States, 63110
United States, Ohio
Research Site
Columbus, Ohio, United States, 43215
Sponsors and Collaborators
Aridis Pharmaceuticals, Inc.
Investigators
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Study Chair: Bruno François, MD Hospital Dupuytren

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Responsible Party: Aridis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03027609     History of Changes
Other Study ID Numbers: AR-105-002
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aridis Pharmaceuticals, Inc.:
Pseudomonas aeruginosa
pneumonia

Additional relevant MeSH terms:
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Pneumonia
Pseudomonas Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs