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

Pseudomonas Aeruginosa Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03027609
• Other study ID #: AR-105-002
• Status: Completed
• Phase: Phase 2
• Start date: March 29, 2017
• Est. completion date: April 25, 2019

Study information

• Verified date: August 2019
• Source: Aridis Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: April 25, 2019
• Est. primary completion date: April 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• Pseudomonas Aeruginosa Pneumonia
• Pseudomonas Infections

Intervention

Drug:
• AR-105
monoclonal antibody
• Placebo
matching placebo (+ SOC antibiotics)

Locations

Country	Name	City	State
Australia	Research Site	Adelaide
Australia	Research Site	Woolloongabba
Belarus	Research Site	Brest
Belarus	Research Site	Gomel
Belarus	Research Site	Grodno
Belarus	Research Site	Minsk
Belarus	Research Site	Minsk
Belarus	Research Site	Vitebsk
Belgium	Research Site	Brussels
Belgium	Research Site	Brussels
Belgium	Research Site	Brussels
Belgium	Research Site	Dinant
Belgium	Research Site	Liège
Belgium	Research Site	Yvoir
Czechia	Research Site	Brno
Czechia	Research Site	Plzen
Czechia	Research Site	Praha
Czechia	Research Site	Praha
Czechia	Research Site	Praha
Czechia	Research Site	Teplice
Czechia	Research Site	Zlín
France	Research Site	Angers
France	Research Site	Argenteuil
France	Research Site	Colombes
France	Research Site	La Roche-sur-Yon
France	Research Site	Le Chesnay
France	Research Site	Lille
France	Research Site	Limoges
France	Research Site	Lyon
France	Research Site	Lyon
France	Research Site	Nantes
France	Research Site	Paris
France	Research Site 1	Paris
France	Research Site 2	Paris
France	Research Site	Pierre-Bénite
France	Research Site	Pontoise
France	Research Site	Strasbourg
France	Research Site	Tourcoing
France	Research Site	Tours
Georgia	Research Site 1	Kutaisi
Georgia	Research Site 2	Kutaisi
Georgia	Research Site	Tbilisi
Greece	Research Site 1	Athens
Greece	Research Site 2	Athens
Greece	Research Site 1	Larissa
Greece	Research Site 2	Larissa
Hungary	Research Site 1	Budapest
Hungary	Research Site 2	Budapest
Hungary	Research Site 3	Budapest
Hungary	Research Site	Debrecen
Hungary	Research Site	Nyiregyhaza
Korea, Republic of	Research Site 1	Gyeonggi-do
Korea, Republic of	Research Site 2	Gyeonggi-do
Korea, Republic of	Research Site 1	Seoul
Korea, Republic of	Research Site 2	Seoul
Korea, Republic of	Research Site 3	Seoul
Korea, Republic of	Research Site 4	Seoul
Korea, Republic of	Research Site	Wonju
Mexico	Research Site 1	Guadalajara
Mexico	Research Site 2	Guadalajara
Mexico	Research Site	Monterrey
Peru	Research Site	Lima
Peru	Research Site	Miraflores
Peru	Research Site	San Martín De Porres
Poland	Research Site	Opole
Poland	Research Site	Warsaw
Russian Federation	Research Site	Krasnodar
Russian Federation	Research Site	Krasnoyarsk
Russian Federation	Research Site 1	Novosibirsk
Russian Federation	Research Site 2	Novosibirsk
Russian Federation	Research Site 3	Novosibirsk
Russian Federation	Research Site 1	Saint Petersburg
Russian Federation	Research Site 2	Saint Petersburg
Russian Federation	Research Site 3	Saint Petersburg
Russian Federation	Research Site 4	Saint Petersburg
Russian Federation	Research Site	Tomsk
Spain	Research Site 1	Barcelona
Spain	Research Site 2	Barcelona
Spain	Research Site 3	Barcelona
Spain	Research Site 4	Barcelona
Spain	Research Site	Madrid
Spain	Research Site	Mataró
Spain	Research Site	Oviedo
Spain	Research Site	Santander
Spain	Research Site	Tarragona
Taiwan	Research Site 1	Kaohsiung
Taiwan	Research Site 2	Kaohsiung
Taiwan	Research Site 1	Taichung
Taiwan	Research Site 2	Taichung
Taiwan	Research Site	Tainan
Taiwan	Research Site 1	Taipei
Taiwan	Research Site 2	Taipei
Taiwan	Research Site 3	Taipei
Taiwan	Research Site 4	Taipei
Ukraine	Research Site	Ivano-Frankivs'k
Ukraine	Research Site	Kiev
Ukraine	Research Site	Lviv
United States	Research Site 5	Chicago	Illinois
United States	Research Site	Columbus	Ohio
United States	Research Site 7	Detroit	Michigan
United States	Research Site 8	Detroit	Michigan
United States	Research Site	Durham	North Carolina
United States	Research Site	Hackensack	New Jersey
United States	Research Site 3	Jacksonville	Florida
United States	Research Site 6	Lexington	Kentucky
United States	Research Site 9	Royal Oak	Michigan
United States	Research Site 1	Sacramento	California
United States	Research Site	Saint Louis	Missouri
United States	Research Site 10	Saint Louis	Missouri
United States	Research Site 2	San Diego	California
United States	Research Site 4	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Aridis Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belarus,  Belgium,  Czechia,  France,  Georgia,  Greece,  Hungary,  Korea, Republic of,  Mexico,  Peru,  Poland,  Russian Federation,  Spain,  Taiwan,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	21 days following dosing
Secondary	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	7 days following dosing
Secondary	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	14 days following dosing
Secondary	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	28 days following dosing