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

March 8, 2022 updated by: Aridis Pharmaceuticals, Inc.

Placebo-controlled, Double-blind, Randomized Study of Aerucin® as Adjunct Therapy to Antibiotics in the Treatment of P. Aeruginosa Pneumonia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

158

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia, 5000
        • Research Site
      • Woolloongabba, Australia, QLD 4102
        • Research Site
  • Belarus
      • Brest, Belarus, 224027
        • Research Site
      • Gomel, Belarus, 246027
        • Research Site
      • Grodno, Belarus, 230030
        • Research Site
      • Minsk, Belarus, 220049
        • Research Site
      • Minsk, Belarus, 223041
        • Research Site
      • Vitebsk, Belarus, 210037
        • Research Site
  • Belgium
      • Brussels, Belgium, 1090
        • Research Site
      • Brussels, Belgium, 11070
        • Research Site
      • Brussels, Belgium, 1200
        • Research Site
      • Dinant, Belgium, 5500
        • Research Site
      • Liège, Belgium, 4000
        • Research Site
      • Yvoir, Belgium, 5530
        • Research Site
  • Czechia
      • Brno, Czechia, 65691
        • Research Site
      • Plzen, Czechia, 30460
        • Research Site
      • Praha, Czechia, 10034
        • Research Site
      • Praha, Czechia, 12808
        • Research Site
      • Praha, Czechia, 16902
        • Research Site
      • Teplice, Czechia, 41529
        • Research Site
      • Zlín, Czechia, 76275
        • Research Site
  • France
      • Angers, France, 49933
        • Research Site
      • Argenteuil, France, 95107
        • Research Site
      • Colombes, France, 92701
        • Research Site
      • La Roche-sur-Yon, France, 85925
        • Research Site
      • Le Chesnay, France, 78157
        • Research Site
      • Lille, France, 59037
        • Research Site
      • Limoges, France, 87042
        • Research Site
      • Lyon, France, 69004
        • Research Site
      • Lyon, France, 69677
        • Research Site
      • Nantes, France, 44093
        • Research Site
      • Paris, France, 75013
        • Research Site 1
      • Paris, France, 75013
        • Research Site 2
      • Paris, France, 75013
        • Research Site
      • Pierre-Bénite, France, 69495
        • Research Site
      • Pontoise, France, 95303
        • Research Site
      • Strasbourg, France, 67091
        • Research Site
      • Tourcoing, France, 59208
        • Research Site
      • Tours, France, 37044
        • Research Site
  • Georgia
      • Kutaisi, Georgia, 4600
        • Research Site 1
      • Kutaisi, Georgia, 4600
        • Research Site 2
      • Tbilisi, Georgia, 0144
        • Research Site
  • Greece
      • Athens, Greece, 10676
        • Research Site 1
      • Athens, Greece, 11527
        • Research Site 2
      • Larissa, Greece, 41110
        • Research Site 1
      • Larissa, Greece, 41221
        • Research Site 2
  • Hungary
      • Budapest, Hungary, 1122
        • Research Site 3
      • Budapest, Hungary, H-1082
        • Research Site 2
      • Budapest, Hungary, H-1134
        • Research Site 1
      • Debrecen, Hungary, H-4032
        • Research Site
      • Nyiregyhaza, Hungary, H-4400
        • Research Site
  • Korea, Republic of
      • Gyeonggi-do, Korea, Republic of, 425-707
        • Research Site 1
      • Gyeonggi-do, Korea, Republic of, 442-723
        • Research Site 2
      • Seoul, Korea, Republic of, 02841
        • Research Site 2
      • Seoul, Korea, Republic of, 03080
        • Research Site 1
      • Seoul, Korea, Republic of, 05505
        • Research Site 3
      • Seoul, Korea, Republic of, 07441
        • Research Site 4
      • Wŏnju, Korea, Republic of, 26426
        • Research Site
  • Mexico
      • Guadalajara, Mexico, 44280
        • Research Site 1
      • Guadalajara, Mexico, 44760
        • Research Site 2
      • Monterrey, Mexico, 64460
        • Research Site
  • Peru
      • Lima, Peru, 15072
        • Research Site
      • Miraflores, Peru, 15074
        • Research Site
      • San Martín De Porres, Peru, 15102
        • Research Site
  • Poland
      • Opole, Poland, 45-418
        • Research Site
      • Warsaw, Poland, 02-781
        • Research Site
  • Russian Federation
      • Krasnodar, Russian Federation, 350012
        • Research Site
      • Krasnoyarsk, Russian Federation, 660022
        • Research Site
      • Novosibirsk, Russian Federation, 119049
        • Research Site 2
      • Novosibirsk, Russian Federation, 630051
        • Research Site 3
      • Novosibirsk, Russian Federation, 630075
        • Research Site 1
      • Saint Petersburg, Russian Federation, 192242
        • Research Site 2
      • Saint Petersburg, Russian Federation, 196067
        • Research Site 3
      • Saint Petersburg, Russian Federation, 196247
        • Research Site 4
      • Saint Petersburg, Russian Federation, 197706
        • Research Site 1
      • Tomsk, Russian Federation, 634050
        • Research Site
  • Spain
      • Barcelona, Spain, 08036
        • Research Site 1
      • Barcelona, Spain, 08221
        • Research Site 2
      • Barcelona, Spain, 08221
        • Research Site 3
      • Barcelona, Spain, 0897
        • Research Site 4
      • Madrid, Spain, 28040
        • Research Site
      • Mataró, Spain, 08034
        • Research Site
      • Oviedo, Spain, 33011
        • Research Site
      • Santander, Spain, 39008
        • Research Site
      • Tarragona, Spain, 43005
        • Research Site
  • Taiwan
      • Kaohsiung, Taiwan, 80756
        • Research Site 1
      • Kaohsiung, Taiwan, 81362
        • Research Site 2
      • Taichung, Taiwan, 40447
        • Research Site 2
      • Taichung, Taiwan, 40705
        • Research Site 1
      • Tainan, Taiwan, 71004
        • Research Site
      • Taipei, Taiwan, 10002 R.O.C
        • Research Site 1
      • Taipei, Taiwan, 10449
        • Research Site 4
      • Taipei, Taiwan, 11217
        • Research Site 2
      • Taipei, Taiwan, 114
        • Research Site 3
  • Ukraine
      • Ivano-Frankivs'k, Ukraine, 76008
        • Research Site
      • Kiev, Ukraine, 01034
        • Research Site
      • Lviv, Ukraine, 79059
        • Research Site
  • United States
    • California
      • Sacramento, California, United States, 95814
        • Research Site 1
      • San Diego, California, United States, 92103
        • Research Site 2
    • Florida
      • Jacksonville, Florida, United States, 32209
        • Research Site 3
      • Tampa, Florida, United States, 33606
        • Research Site 4
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Research Site 5
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Research Site 6
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Research Site 7
      • Detroit, Michigan, United States, 48201
        • Research Site 8
      • Royal Oak, Michigan, United States, 48073
        • Research Site 9
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Research Site
      • Saint Louis, Missouri, United States, 63110
        • Research Site 10
    • New Jersey
      • Hackensack, New Jersey, United States, 02601
        • Research Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Research Site
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed consent
  • ≥18 years of age, ≥ 20 years of age (Taiwan only),≥ 19 (S. Korea only)
  • pneumonia due to P. aeruginosa
  • mechanically-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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 (+ SOC antibiotics)
Other Names:
  • Control (SOC antibiotics)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Cure on Day 21
Time Frame: 21 days following dosing
A summary of the number (%) of patients who were cured on or before Day 21 (micro-ITT population) is provided, by treatment group
21 days following dosing

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Cure on Day 7
Time Frame: 7 days following dosing
A summary of the number (%) of patients who were cured on or before Day 7 (micro-ITT population) is provided, by treatment group
7 days following dosing
Clinical Cure on Day 14
Time Frame: 14 days following dosing
A summary of the number (%) of patients who were cured on or before Day 14 (micro-ITT population) is provided by treatment group
14 days following dosing
Clinical Cure on Day 28
Time Frame: 28 days following dosing
A summary of the number (%) of patients who were cured on or before Day 28 (micro-ITT population) is provided by treatment group
28 days following dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aridis Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2017

Primary Completion (Actual)

April 25, 2019

Study Completion (Actual)

April 25, 2019

Study Registration Dates

First Submitted

January 17, 2017

First Submitted That Met QC Criteria

January 18, 2017

First Posted (Estimate)

January 23, 2017

Study Record Updates

Last Update Posted (Actual)

March 17, 2022

Last Update Submitted That Met QC Criteria

March 8, 2022

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AR-105-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pseudomonas Aeruginosa Pneumonia

Clinical Trials on AR-105

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe