Back to resultsAdjunctive Therapeutic Treatment With Human Monoclonal Antibody AR-105 (Aerucin®) in P. Aeruginosa Pneumonia
Primary Purpose
Pseudomonas Aeruginosa Pneumonia
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AR-105
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pseudomonas Aeruginosa Pneumonia focused on measuring Pseudomonas aeruginosa, pneumonia
Eligibility Criteria
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
Sites / Locations
- Research Site 1
- Research Site 2
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AR-105
Control
Arm Description
One intravenous infusion of AR-105 20mg/'kg
Matching placebo
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
Full Information
NCT ID
NCT03027609
First Posted
January 17, 2017
Last Updated
March 8, 2022
Sponsor
Aridis Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03027609
Brief Title
Adjunctive Therapeutic Treatment With Human Monoclonal Antibody AR-105 (Aerucin®) in P. Aeruginosa Pneumonia
Official Title
Placebo-controlled, Double-blind, Randomized Study of Aerucin® as Adjunct Therapy to Antibiotics in the Treatment of P. Aeruginosa Pneumonia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 29, 2017 (Actual)
Primary Completion Date
April 25, 2019 (Actual)
Study Completion Date
April 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aridis Pharmaceuticals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pseudomonas Aeruginosa Pneumonia
Keywords
Pseudomonas aeruginosa, pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
158 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AR-105
Arm Type
Experimental
Arm Description
One intravenous infusion of AR-105 20mg/'kg
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Matching placebo
Intervention Type
Drug
Intervention Name(s)
AR-105
Other Intervention Name(s)
Aerubumab, Aerucin
Intervention Description
monoclonal antibody
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Control (SOC antibiotics)
Intervention Description
matching placebo (+ SOC antibiotics)
Primary Outcome Measure Information:
Title
Clinical Cure on Day 21
Description
A summary of the number (%) of patients who were cured on or before Day 21 (micro-ITT population) is provided, by treatment group
Time Frame
21 days following dosing
Secondary Outcome Measure Information:
Title
Clinical Cure on Day 7
Description
A summary of the number (%) of patients who were cured on or before Day 7 (micro-ITT population) is provided, by treatment group
Time Frame
7 days following dosing
Title
Clinical Cure on Day 14
Description
A summary of the number (%) of patients who were cured on or before Day 14 (micro-ITT population) is provided by treatment group
Time Frame
14 days following dosing
Title
Clinical Cure on Day 28
Description
A summary of the number (%) of patients who were cured on or before Day 28 (micro-ITT population) is provided by treatment group
Time Frame
28 days following dosing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Research Site 1
City
Sacramento
State/Province
California
ZIP/Postal Code
95814
Country
United States
Facility Name
Research Site 2
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Research Site 3
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Research Site 4
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Research Site 5
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Research Site 6
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Research Site 7
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Research Site 8
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Research Site 9
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Research Site 10
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Research Site
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
02601
Country
United States
Facility Name
Research Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Research Site
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
Facility Name
Research Site
City
Woolloongabba
ZIP/Postal Code
QLD 4102
Country
Australia
Facility Name
Research Site
City
Brest
ZIP/Postal Code
224027
Country
Belarus
Facility Name
Research Site
City
Gomel
ZIP/Postal Code
246027
Country
Belarus
Facility Name
Research Site
City
Grodno
ZIP/Postal Code
230030
Country
Belarus
Facility Name
Research Site
City
Minsk
ZIP/Postal Code
220049
Country
Belarus
Facility Name
Research Site
City
Minsk
ZIP/Postal Code
223041
Country
Belarus
Facility Name
Research Site
City
Vitebsk
ZIP/Postal Code
210037
Country
Belarus
Facility Name
Research Site
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Research Site
City
Brussels
ZIP/Postal Code
11070
Country
Belgium
Facility Name
Research Site
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Research Site
City
Dinant
ZIP/Postal Code
5500
Country
Belgium
Facility Name
Research Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Research Site
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Research Site
City
Brno
ZIP/Postal Code
65691
Country
Czechia
Facility Name
Research Site
City
Plzen
ZIP/Postal Code
30460
Country
Czechia
Facility Name
Research Site
City
Praha
ZIP/Postal Code
10034
Country
Czechia
Facility Name
Research Site
City
Praha
ZIP/Postal Code
12808
Country
Czechia
Facility Name
Research Site
City
Praha
ZIP/Postal Code
16902
Country
Czechia
Facility Name
Research Site
City
Teplice
ZIP/Postal Code
41529
Country
Czechia
Facility Name
Research Site
City
Zlín
ZIP/Postal Code
76275
Country
Czechia
Facility Name
Research Site
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Research Site
City
Argenteuil
ZIP/Postal Code
95107
Country
France
Facility Name
Research Site
City
Colombes
ZIP/Postal Code
92701
Country
France
Facility Name
Research Site
City
La Roche-sur-Yon
ZIP/Postal Code
85925
Country
France
Facility Name
Research Site
City
Le Chesnay
ZIP/Postal Code
78157
Country
France
Facility Name
Research Site
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Research Site
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Research Site
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
Research Site
City
Lyon
ZIP/Postal Code
69677
Country
France
Facility Name
Research Site
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Research Site 1
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Research Site 2
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Research Site
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Research Site
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
Research Site
City
Pontoise
ZIP/Postal Code
95303
Country
France
Facility Name
Research Site
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Research Site
City
Tourcoing
ZIP/Postal Code
59208
Country
France
Facility Name
Research Site
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Research Site 1
City
Kutaisi
ZIP/Postal Code
4600
Country
Georgia
Facility Name
Research Site 2
City
Kutaisi
ZIP/Postal Code
4600
Country
Georgia
Facility Name
Research Site
City
Tbilisi
ZIP/Postal Code
0144
Country
Georgia
Facility Name
Research Site 1
City
Athens
ZIP/Postal Code
10676
Country
Greece
Facility Name
Research Site 2
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Research Site 1
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Facility Name
Research Site 2
City
Larissa
ZIP/Postal Code
41221
Country
Greece
Facility Name
Research Site 3
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Research Site 2
City
Budapest
ZIP/Postal Code
H-1082
Country
Hungary
Facility Name
Research Site 1
City
Budapest
ZIP/Postal Code
H-1134
Country
Hungary
Facility Name
Research Site
City
Debrecen
ZIP/Postal Code
H-4032
Country
Hungary
Facility Name
Research Site
City
Nyiregyhaza
ZIP/Postal Code
H-4400
Country
Hungary
Facility Name
Research Site 1
City
Gyeonggi-do
ZIP/Postal Code
425-707
Country
Korea, Republic of
Facility Name
Research Site 2
City
Gyeonggi-do
ZIP/Postal Code
442-723
Country
Korea, Republic of
Facility Name
Research Site 2
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Research Site 1
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Research Site 3
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Research Site 4
City
Seoul
ZIP/Postal Code
07441
Country
Korea, Republic of
Facility Name
Research Site
City
Wŏnju
ZIP/Postal Code
26426
Country
Korea, Republic of
Facility Name
Research Site 1
City
Guadalajara
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Research Site 2
City
Guadalajara
ZIP/Postal Code
44760
Country
Mexico
Facility Name
Research Site
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Research Site
City
Lima
ZIP/Postal Code
15072
Country
Peru
Facility Name
Research Site
City
Miraflores
ZIP/Postal Code
15074
Country
Peru
Facility Name
Research Site
City
San Martín De Porres
ZIP/Postal Code
15102
Country
Peru
Facility Name
Research Site
City
Opole
ZIP/Postal Code
45-418
Country
Poland
Facility Name
Research Site
City
Warsaw
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Research Site
City
Krasnodar
ZIP/Postal Code
350012
Country
Russian Federation
Facility Name
Research Site
City
Krasnoyarsk
ZIP/Postal Code
660022
Country
Russian Federation
Facility Name
Research Site 2
City
Novosibirsk
ZIP/Postal Code
119049
Country
Russian Federation
Facility Name
Research Site 3
City
Novosibirsk
ZIP/Postal Code
630051
Country
Russian Federation
Facility Name
Research Site 1
City
Novosibirsk
ZIP/Postal Code
630075
Country
Russian Federation
Facility Name
Research Site 2
City
Saint Petersburg
ZIP/Postal Code
192242
Country
Russian Federation
Facility Name
Research Site 3
City
Saint Petersburg
ZIP/Postal Code
196067
Country
Russian Federation
Facility Name
Research Site 4
City
Saint Petersburg
ZIP/Postal Code
196247
Country
Russian Federation
Facility Name
Research Site 1
City
Saint Petersburg
ZIP/Postal Code
197706
Country
Russian Federation
Facility Name
Research Site
City
Tomsk
ZIP/Postal Code
634050
Country
Russian Federation
Facility Name
Research Site 1
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Research Site 2
City
Barcelona
ZIP/Postal Code
08221
Country
Spain
Facility Name
Research Site 3
City
Barcelona
ZIP/Postal Code
08221
Country
Spain
Facility Name
Research Site 4
City
Barcelona
ZIP/Postal Code
0897
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Research Site
City
Mataró
ZIP/Postal Code
08034
Country
Spain
Facility Name
Research Site
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Facility Name
Research Site
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Research Site
City
Tarragona
ZIP/Postal Code
43005
Country
Spain
Facility Name
Research Site 1
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Facility Name
Research Site 2
City
Kaohsiung
ZIP/Postal Code
81362
Country
Taiwan
Facility Name
Research Site 2
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Research Site 1
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Research Site
City
Tainan
ZIP/Postal Code
71004
Country
Taiwan
Facility Name
Research Site 1
City
Taipei
ZIP/Postal Code
10002 R.O.C
Country
Taiwan
Facility Name
Research Site 4
City
Taipei
ZIP/Postal Code
10449
Country
Taiwan
Facility Name
Research Site 2
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Research Site 3
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
Facility Name
Research Site
City
Ivano-Frankivs'k
ZIP/Postal Code
76008
Country
Ukraine
Facility Name
Research Site
City
Kiev
ZIP/Postal Code
01034
Country
Ukraine
Facility Name
Research Site
City
Lviv
ZIP/Postal Code
79059
Country
Ukraine
12. IPD Sharing Statement
Plan to Share IPD
No
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Adjunctive Therapeutic Treatment With Human Monoclonal Antibody AR-105 (Aerucin®) in P. Aeruginosa Pneumonia
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