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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03027609




Registration number
NCT03027609
Ethics application status
Date submitted
17/01/2017
Date registered
23/01/2017

Titles & IDs
Public title
Adjunctive Therapeutic Treatment With Human Monoclonal Antibody AR-105 (Aerucin®) in P. Aeruginosa Pneumonia
Scientific title
Placebo-controlled, Double-blind, Randomized Study of Aerucin® as Adjunct Therapy to Antibiotics in the Treatment of P. Aeruginosa Pneumonia
Secondary ID [1] 0 0
AR-105-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pseudomonas Aeruginosa Pneumonia 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AR-105
Treatment: Drugs - Placebo

Experimental: AR-105 - One intravenous infusion of AR-105 20mg/'kg

Placebo comparator: Control - Matching placebo


Treatment: Drugs: AR-105
monoclonal antibody

Treatment: Drugs: Placebo
matching placebo (+ SOC antibiotics)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical Cure on Day 21
Timepoint [1] 0 0
21 days following dosing
Secondary outcome [1] 0 0
Clinical Cure on Day 7
Timepoint [1] 0 0
7 days following dosing
Secondary outcome [2] 0 0
Clinical Cure on Day 14
Timepoint [2] 0 0
14 days following dosing
Secondary outcome [3] 0 0
Clinical Cure on Day 28
Timepoint [3] 0 0
28 days following dosing

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/03/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/04/2019
Sample size
Target
Accrual to date
Final
158
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Adelaide
Recruitment hospital [2] 0 0
Research Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
QLD 4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
Belarus
State/province [10] 0 0
Brest
Country [11] 0 0
Belarus
State/province [11] 0 0
Gomel
Country [12] 0 0
Belarus
State/province [12] 0 0
Grodno
Country [13] 0 0
Belarus
State/province [13] 0 0
Minsk
Country [14] 0 0
Belarus
State/province [14] 0 0
Vitebsk
Country [15] 0 0
Belgium
State/province [15] 0 0
Brussels
Country [16] 0 0
Belgium
State/province [16] 0 0
Dinant
Country [17] 0 0
Belgium
State/province [17] 0 0
Liège
Country [18] 0 0
Belgium
State/province [18] 0 0
Yvoir
Country [19] 0 0
Czechia
State/province [19] 0 0
Brno
Country [20] 0 0
Czechia
State/province [20] 0 0
Plzen
Country [21] 0 0
Czechia
State/province [21] 0 0
Praha
Country [22] 0 0
Czechia
State/province [22] 0 0
Teplice
Country [23] 0 0
Czechia
State/province [23] 0 0
Zlín
Country [24] 0 0
France
State/province [24] 0 0
Angers
Country [25] 0 0
France
State/province [25] 0 0
Argenteuil
Country [26] 0 0
France
State/province [26] 0 0
Colombes
Country [27] 0 0
France
State/province [27] 0 0
La Roche-sur-Yon
Country [28] 0 0
France
State/province [28] 0 0
Le Chesnay
Country [29] 0 0
France
State/province [29] 0 0
Lille
Country [30] 0 0
France
State/province [30] 0 0
Limoges
Country [31] 0 0
France
State/province [31] 0 0
Lyon
Country [32] 0 0
France
State/province [32] 0 0
Nantes
Country [33] 0 0
France
State/province [33] 0 0
Paris
Country [34] 0 0
France
State/province [34] 0 0
Pierre-Bénite
Country [35] 0 0
France
State/province [35] 0 0
Pontoise
Country [36] 0 0
France
State/province [36] 0 0
Strasbourg
Country [37] 0 0
France
State/province [37] 0 0
Tourcoing
Country [38] 0 0
France
State/province [38] 0 0
Tours
Country [39] 0 0
Georgia
State/province [39] 0 0
Kutaisi
Country [40] 0 0
Georgia
State/province [40] 0 0
Tbilisi
Country [41] 0 0
Greece
State/province [41] 0 0
Athens
Country [42] 0 0
Greece
State/province [42] 0 0
Larissa
Country [43] 0 0
Hungary
State/province [43] 0 0
Budapest
Country [44] 0 0
Hungary
State/province [44] 0 0
Debrecen
Country [45] 0 0
Hungary
State/province [45] 0 0
Nyiregyhaza
Country [46] 0 0
Korea, Republic of
State/province [46] 0 0
Gyeonggi-do
Country [47] 0 0
Korea, Republic of
State/province [47] 0 0
Seoul
Country [48] 0 0
Korea, Republic of
State/province [48] 0 0
Wonju
Country [49] 0 0
Mexico
State/province [49] 0 0
Guadalajara
Country [50] 0 0
Mexico
State/province [50] 0 0
Monterrey
Country [51] 0 0
Peru
State/province [51] 0 0
Lima
Country [52] 0 0
Peru
State/province [52] 0 0
Miraflores
Country [53] 0 0
Peru
State/province [53] 0 0
San Martín De Porres
Country [54] 0 0
Poland
State/province [54] 0 0
Opole
Country [55] 0 0
Poland
State/province [55] 0 0
Warsaw
Country [56] 0 0
Russian Federation
State/province [56] 0 0
Krasnodar
Country [57] 0 0
Russian Federation
State/province [57] 0 0
Krasnoyarsk
Country [58] 0 0
Russian Federation
State/province [58] 0 0
Novosibirsk
Country [59] 0 0
Russian Federation
State/province [59] 0 0
Saint Petersburg
Country [60] 0 0
Russian Federation
State/province [60] 0 0
Tomsk
Country [61] 0 0
Spain
State/province [61] 0 0
Barcelona
Country [62] 0 0
Spain
State/province [62] 0 0
Madrid
Country [63] 0 0
Spain
State/province [63] 0 0
Mataró
Country [64] 0 0
Spain
State/province [64] 0 0
Oviedo
Country [65] 0 0
Spain
State/province [65] 0 0
Santander
Country [66] 0 0
Spain
State/province [66] 0 0
Tarragona
Country [67] 0 0
Taiwan
State/province [67] 0 0
Kaohsiung
Country [68] 0 0
Taiwan
State/province [68] 0 0
Taichung
Country [69] 0 0
Taiwan
State/province [69] 0 0
Tainan
Country [70] 0 0
Taiwan
State/province [70] 0 0
Taipei
Country [71] 0 0
Ukraine
State/province [71] 0 0
Ivano-Frankivs'k
Country [72] 0 0
Ukraine
State/province [72] 0 0
Kiev
Country [73] 0 0
Ukraine
State/province [73] 0 0
Lviv

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Aridis Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03027609