Pseudomonas Aeruginosa PneumoniaPhase 2NCT03027609

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

A Phase 2 study testing AR-105 in people with Pseudomonas Aeruginosa Pneumonia, run by Aridis Pharmaceuticals, Inc. at 111 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pseudomonas Aeruginosa Pneumonia
What is being tested?: AR-105
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 158 participants
Where: 111 sitesin 17 countries
Study dates: 29 Mar 2017to 25 Apr 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

being moribund
effective antibiotic therapy ≥48 hours
immunocompromised
underlying pulmonary disease that may preclude the assessment of a therapeutic response

Trial locations and contacts

111 sites in 17 countries.

Country

City, postcode or hospital

111 sites in 17 countries

France18 sites

Research Site
Angers, 49933
Research Site
Argenteuil, 95107
Research Site
Colombes, 92701
Research Site
La Roche-sur-Yon, 85925
Research Site
Le Chesnay, 78157
Research Site
Lille, 59037
Research Site
Limoges, 87042
Research Site
Lyon, 69004
Research Site
Lyon, 69677
Research Site
Nantes, 44093
Research Site 1
Paris, 75013
Research Site 2
Paris, 75013
Research Site
Paris, 75013
Research Site
Pierre-Bénite, 69495
Research Site
Pontoise, 95303
Research Site
Strasbourg, 67091
Research Site
Tourcoing, 59208
Research Site
Tours, 37044

Other trials in France

United States14 sites

Research Site 5
Chicago, Illinois, 60611
Research Site
Columbus, Ohio, 43215
Research Site 7
Detroit, Michigan, 48201
Research Site 8
Detroit, Michigan, 48201
Research Site
Durham, North Carolina, 27710
Research Site
Hackensack, New Jersey, 02601
Research Site 3
Jacksonville, Florida, 32209
Research Site 6
Lexington, Kentucky, 40536
Research Site 9
Royal Oak, Michigan, 48073
Research Site 1
Sacramento, California, 95814
Research Site 2
San Diego, California, 92103
Research Site 10
St Louis, Missouri, 63110
Research Site
St Louis, Missouri, 63141
Research Site 4
Tampa, Florida, 33606

Other trials in United States

Russia10 sites

Research Site
Krasnodar, 350012
Research Site
Krasnoyarsk, 660022
Research Site 2
Novosibirsk, 119049
Research Site 3
Novosibirsk, 630051
Research Site 1
Novosibirsk, 630075
Research Site 2
Saint Petersburg, 192242
Research Site 3
Saint Petersburg, 196067
Research Site 4
Saint Petersburg, 196247
Research Site 1
Saint Petersburg, 197706
Research Site
Tomsk, 634050

Other trials in Russia

Spain9 sites

Research Site 1
Barcelona, 08036
Research Site 2
Barcelona, 08221
Research Site 3
Barcelona, 08221
Research Site 4
Barcelona, 0897
Research Site
Madrid, 28040
Research Site
Mataró, 08034
Research Site
Oviedo, 33011
Research Site
Santander, 39008
Research Site
Tarragona, 43005

Other trials in Spain

Taiwan9 sites

Research Site 1
Kaohsiung City, 80756
Research Site 2
Kaohsiung City, 81362
Research Site 2
Taichung, 40447
Research Site 1
Taichung, 40705
Research Site
Tainan, 71004
Research Site 1
Taipei, 10002 R.O.C
Research Site 4
Taipei, 10449
Research Site 2
Taipei, 11217
Research Site 3
Taipei, 114

Other trials in Taiwan

Czechia7 sites

Research Site
Brno, 65691
Research Site
Pilsen, 30460
Research Site
Prague, 10034
Research Site
Prague, 12808
Research Site
Prague, 16902
Research Site
Teplice, 41529
Research Site
Zlín, 76275

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South Korea7 sites

Research Site 1
Gyeonggi-do, 425-707
Research Site 2
Gyeonggi-do, 442-723
Research Site 2
Seoul, 02841
Research Site 1
Seoul, 03080
Research Site 3
Seoul, 05505
Research Site 4
Seoul, 07441
Research Site
Wŏnju, 26426

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Belarus6 sites

Research Site
Brest, 224027
Research Site
Grodno, 230030
Research Site
Homyel, 246027
Research Site
Minsk, 220049
Research Site
Minsk, 223041
Research Site
Vitebsk, 210037

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Belgium6 sites

Research Site
Brussels, 1090
Research Site
Brussels, 11070
Research Site
Brussels, 1200
Research Site
Dinant, 5500
Research Site
Liège, 4000
Research Site
Yvoir, 5530

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Hungary5 sites

Research Site 3
Budapest, 1122
Research Site 2
Budapest, H-1082
Research Site 1
Budapest, H-1134
Research Site
Debrecen, H-4032
Research Site
Nyíregyháza, H-4400

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Greece4 sites

Research Site 1
Athens, 10676
Research Site 2
Athens, 11527
Research Site 1
Larissa, 41110
Research Site 2
Larissa, 41221

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Georgia3 sites

Research Site 1
Kutaisi, 4600
Research Site 2
Kutaisi, 4600
Research Site
Tbilisi, 0144

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Mexico3 sites

Research Site 1
Guadalajara, 44280
Research Site 2
Guadalajara, 44760
Research Site
Monterrey, 64460

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Peru3 sites

Research Site
Lima, 15072
Research Site
Miraflores, 15074
Research Site
San Martín de Porres, 15102

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Ukraine3 sites

Research Site
Ivano-Frankivsk, 76008
Research Site
Kiev, 01034
Research Site
Lviv, 79059

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Australia2 sites

Research Site
Adelaide, 5000
Research Site
Woolloongabba, QLD 4102

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Poland2 sites

Research Site
Opole, 45-418
Research Site
Warsaw, 02-781

Other trials in Poland

About this study

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

Read the 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.

Conditions: Pseudomonas Aeruginosa Pneumonia
Being tested: AR-105, Placebo
Keywords: Pseudomonas aeruginosa, pneumonia
Medical subject headings: Pseudomonas Infections, Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AR-105Drug
Also called Aerubumab, Aerucin
monoclonal antibody
PlaceboDrug
Also called Control (SOC antibiotics)
matching placebo (+ SOC antibiotics)

Study groups in NCT03027609
Study group	Role	What they receive
AR-105	Experimental	One intravenous infusion of AR-105 20mg/'kg Receives: Drug: AR-105
Control	Placebo comparator	Matching placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Mar 201725 Apr 2019

First posted23 Jan 2017 (estimated)
Study start29 Mar 2017
Primary completion25 Apr 2019
Study completion25 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pseudomonas Aeruginosa PneumoniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 158 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03027609
Sponsor's protocol ID: AR-105-002
Status last verified: Aug 2019
First submitted: 17 Jan 2017
Last updated: 17 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Blood Stream Infections, Ventilator Associated Pneumonia
Not yet recruitingPhase 3
A Double-Blind, Placebo-Controlled Study of Nebulized Bacteriophages in Patients With Ventilator-Associated Pneumonia Due to Pseudomonas Aeruginosa
Ventilator Associated Bacterial Pneumonia, Pseudomonas Aeruginosa Infection
RecruitingPhase 1
MP101 in Adults With Acute Pseudomonas Aeruginosa Pneumonia
Pneumonia - Bacterial, Pseudomonas Aeruginosa Infection
RecruitingObservational study
NCCR AntiResist:: New Approaches to Combat Antibiotic-resistant Bacteria
Antimicrobial Resistance (AMR)
Not yet recruitingPhase 3
An Open Clinical Trial of the Safety and Efficacy of the Drug Fluorothiazinone, 300 Mg Tablets with the Participation of Adult Patients with Chronic Bacterial Cystitis"
P. Aeruginosa, Baumannii

All Pseudomonas Aeruginosa Pneumonia trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Placebo-controlled, Double-blind, Randomized Study of Aerucin® as Adjunct Therapy to Antibiotics in the Treatment of P. Aeruginosa Pneumonia
ClinicalTrials.gov ID: NCT03027609
Acronym / sponsor ID: AR-105-002
Conditions: Pseudomonas Aeruginosa Pneumonia
Keywords: Pseudomonas aeruginosa, pneumonia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 158 participants (actual)
Lead sponsor: Aridis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 29 Mar 2017 (actual)
Primary completion: 25 Apr 2019 (actual)
Study completion: 25 Apr 2019 (actual)
First posted: 23 Jan 2017 (estimated)
Results: Posted 9 Mar 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
AR-105	Experimental	Drug: AR-105One intravenous infusion of AR-105 20mg/'kg
Control	Placebo comparator	Drug: PlaceboMatching placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (4 listed)

being moribund
effective antibiotic therapy ≥48 hours
immunocompromised
underlying pulmonary disease that may preclude the assessment of a therapeutic response

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AR-105Also: Aerubumab, Aerucinmonoclonal antibody	Drug	AR-105
PlaceboAlso: Control (SOC antibiotics)matching placebo (+ SOC antibiotics)	Drug	Control

Primary outcome

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

3 secondary outcomes

Clinical Cure on Day 7
Time frame: 7 days following dosing
Clinical Cure on Day 14
Time frame: 14 days following dosing
Clinical Cure on Day 28
Time frame: 28 days following dosing

Results and safety

Results posted to the registry on 9 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AR-105	79	49
Control	79	62

Primary outcome: Clinical Cure on Day 21

Time frame: 21 days following dosing. Count of participants. Unit: Participants

Measure	AR-105 n = 70	Control n = 67
Observed Cured	34	37
Imputed Cured	6	5
Not Cured	25	20
Reinfection same pathogen	5	2
New Infection Different Pathogen	0	3
New infection Unknown pathogen	0	0

AR-105 vs Control: Risk Difference (RD): -5.54 (95% CI -21.9 to 10.8), p = 0.6154, Cochran-Mantel-Haenszel

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 month: from administration day (Day 0) up to Day 28 (28 days after administration). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AR-105	36 of 79 (45.6%)	73 of 79 (92.4%)	25 of 79
Control	22 of 79 (27.8%)	73 of 79 (92.4%)	13 of 79

Limitations and caveats (from the sponsor): A post-hoc analysis was performed on the data reviewed by the AC, using the appropriate clinical severity, adequate antibiotic criteria and the inflammatory status of the patient (level of C-reactive protein \[CRP\]).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Pseudomonas Aeruginosa Pneumonia

RecruitingPhase 4
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Blood Stream Infections, Ventilator Associated Pneumonia
Not yet recruitingPhase 3
A Double-Blind, Placebo-Controlled Study of Nebulized Bacteriophages in Patients With Ventilator-Associated Pneumonia Due to Pseudomonas Aeruginosa
Ventilator Associated Bacterial Pneumonia, Pseudomonas Aeruginosa Infection
RecruitingPhase 1
MP101 in Adults With Acute Pseudomonas Aeruginosa Pneumonia
Pneumonia - Bacterial, Pseudomonas Aeruginosa Infection
RecruitingObservational study
NCCR AntiResist:: New Approaches to Combat Antibiotic-resistant Bacteria
Antimicrobial Resistance (AMR)
Not yet recruitingPhase 3
An Open Clinical Trial of the Safety and Efficacy of the Drug Fluorothiazinone, 300 Mg Tablets with the Participation of Adult Patients with Chronic Bacterial Cystitis"
P. Aeruginosa, Baumannii

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

111 sites in 17 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AR-105 in people with Pseudomonas Aeruginosa Pneumonia, run by Aridis Pharmaceuticals, Inc. at 111 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 111 sites in France, United States, Russia, Spain, Taiwan and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Cure on Day 21 (time frame: 21 days following dosing). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03027609.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.