Clinical trial NCT03027609: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pseudomonas Aeruginosa Pneumonia
Keywords: Pseudomonas aeruginosa
pneumonia
Lead sponsor: Aridis Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2017-01-23
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Clinical Cure on Day 21
timeFrame: 21 days following dosing
Secondary outcomes:
measure: Clinical Cure on Day 7
timeFrame: 7 days following dosing
measure: Clinical Cure on Day 14
timeFrame: 14 days following dosing
measure: Clinical Cure on Day 28
timeFrame: 28 days following dosing
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Research Site 1
state: California
city: San Diego
country: United States
facility: Research Site 2
state: California
city: Jacksonville
country: United States
facility: Research Site 3
state: Florida
city: Tampa
country: United States
facility: Research Site 4
state: Florida
city: Chicago
country: United States
facility: Research Site 5
state: Illinois
city: Lexington
country: United States
facility: Research Site 6
state: Kentucky
city: Detroit
country: United States
facility: Research Site 7
state: Michigan
city: Detroit
country: United States
facility: Research Site 8
state: Michigan
city: Royal Oak
country: United States
facility: Research Site 9
state: Michigan
city: Saint Louis
country: United States
facility: Research Site 10
state: Missouri
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Hackensack
country: United States
facility: Research Site
state: New Jersey
city: Durham
country: United States
facility: Research Site
state: North Carolina
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Adelaide
country: Australia
facility: Research Site
city: Woolloongabba
country: Australia
facility: Research Site
city: Brest
country: Belarus
facility: Research Site
city: Gomel
country: Belarus
facility: Research Site
city: Grodno
country: Belarus
facility: Research Site
city: Minsk
country: Belarus
facility: Research Site
city: Minsk
country: Belarus
facility: Research Site
city: Vitebsk
country: Belarus
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Dinant
country: Belgium
facility: Research Site
city: Liège
country: Belgium
facility: Research Site
city: Yvoir
country: Belgium
facility: Research Site
city: Brno
country: Czechia
facility: Research Site
city: Plzen
country: Czechia
facility: Research Site
city: Praha
country: Czechia
facility: Research Site
city: Praha
country: Czechia
facility: Research Site
city: Praha
country: Czechia
facility: Research Site
city: Teplice
country: Czechia
facility: Research Site
city: Zlín
country: Czechia
facility: Research Site
city: Angers
country: France
facility: Research Site
city: Argenteuil
country: France
facility: Research Site
city: Colombes
country: France
facility: Research Site
city: La Roche-sur-Yon
country: France
facility: Research Site
city: Le Chesnay
country: France
facility: Research Site
city: Lille
country: France
facility: Research Site
city: Limoges
country: France
facility: Research Site
city: Lyon
country: France
facility: Research Site
city: Lyon
country: France
facility: Research Site
city: Nantes
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site 1
city: Paris
country: France
facility: Research Site 2
city: Paris
country: France
facility: Research Site
city: Pierre-Bénite
country: France
facility: Research Site
city: Pontoise
country: France
facility: Research Site
city: Strasbourg
country: France
facility: Research Site
city: Tourcoing
country: France
facility: Research Site
city: Tours
country: France
facility: Research Site
city: Kutaisi
country: Georgia
facility: Research Site 1
city: Kutaisi
country: Georgia
facility: Research Site 2
city: Tbilisi
country: Georgia
facility: Research Site
city: Athens
country: Greece
facility: Research Site 1
city: Athens
country: Greece
facility: Research Site 2
city: Larissa
country: Greece
facility: Research Site 1
city: Larissa
country: Greece
facility: Research Site 2
city: Budapest
country: Hungary
facility: Research Site 3
city: Budapest
country: Hungary
facility: Research Site 2
city: Budapest
country: Hungary
facility: Research Site 1
city: Debrecen
country: Hungary
facility: Research Site
city: Nyiregyhaza
country: Hungary
facility: Research Site
city: Gyeonggi-do
country: Korea, Republic of
facility: Research Site 1
city: Gyeonggi-do
country: Korea, Republic of
facility: Research Site 2
city: Seoul
country: Korea, Republic of
facility: Research Site 2
city: Seoul
country: Korea, Republic of
facility: Research Site 1
city: Seoul
country: Korea, Republic of
facility: Research Site 3
city: Seoul
country: Korea, Republic of
facility: Research Site 4
city: Wŏnju
country: Korea, Republic of
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site 1
city: Guadalajara
country: Mexico
facility: Research Site 2
city: Monterrey
country: Mexico
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Miraflores
country: Peru
facility: Research Site
city: San Martín De Porres
country: Peru
facility: Research Site
city: Opole
country: Poland
facility: Research Site
city: Warsaw
country: Poland
facility: Research Site
city: Krasnodar
country: Russian Federation
facility: Research Site
city: Krasnoyarsk
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site 2
city: Novosibirsk
country: Russian Federation
facility: Research Site 3
city: Novosibirsk
country: Russian Federation
facility: Research Site 1
city: Saint Petersburg
country: Russian Federation
facility: Research Site 2
city: Saint Petersburg
country: Russian Federation
facility: Research Site 3
city: Saint Petersburg
country: Russian Federation
facility: Research Site 4
city: Saint Petersburg
country: Russian Federation
facility: Research Site 1
city: Tomsk
country: Russian Federation
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site 1
city: Barcelona
country: Spain
facility: Research Site 2
city: Barcelona
country: Spain
facility: Research Site 3
city: Barcelona
country: Spain
facility: Research Site 4
city: Madrid
country: Spain
facility: Research Site
city: Mataró
country: Spain
facility: Research Site
city: Oviedo
country: Spain
facility: Research Site
city: Santander
country: Spain
facility: Research Site
city: Tarragona
country: Spain
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site 1
city: Kaohsiung
country: Taiwan
facility: Research Site 2
city: Taichung
country: Taiwan
facility: Research Site 2
city: Taichung
country: Taiwan
facility: Research Site 1
city: Tainan
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site 1
city: Taipei
country: Taiwan
facility: Research Site 4
city: Taipei
country: Taiwan
facility: Research Site 2
city: Taipei
country: Taiwan
facility: Research Site 3
city: Ivano-Frankivs'k
country: Ukraine
facility: Research Site
city: Kiev
country: Ukraine
facility: Research Site
city: Lviv
country: Ukraine
facility: Research Site
Study officials:
References: