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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
158

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 29, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 25, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 25, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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