Clinical trial NCT02696902: Effort to Prevent Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa in Mechanically Ventilated Subjects
Official title: A Phase 2 Proof-of-concept Study to Evaluate the Efficacy and Safety of MEDI3902 in Mechanically Ventilated Patients for the Prevention of Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pseudomonas Aeruginosa
Keywords: Pseudomonas aeruginosa, Pneumonia
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
Collaborators: name: Innovative Medicines Initiative
name: Antibacterial Resistance Leadership Group
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2016-03-02
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Clinical trial looking to evaluate the efficacy and safety of MEDI3902 in mechanically ventilated participants for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa.


Eligibility criteria: Inclusion Criteria:

Colonized with P aeruginosa, expected to require prolonged intubation and mechanical ventilation, without any evidence of active pneumonia.

Exclusion Criteria:

P aeruginosa disease at randomisation; lung injury score consistent with pneumonia; current lung disease; currently receiving protocol-specified Anti-P aeruginosa antibiotics, moribund participants.

Primary outcomes:
measure: Percentage of Participants With Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa
timeFrame: Day 1 through Day 22
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Day 1 through Day 50
measure: Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
timeFrame: Day 1 through Day 50
measure: Number of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESI)
timeFrame: Day 1 through Day 50
Secondary outcomes:
measure: Maximum Observed Concentration (Cmax) of MEDI3902
timeFrame: Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50
measure: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3902
timeFrame: Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50
measure: Clearance (CL) of MEDI3902
timeFrame: Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50
measure: Percentage of Participants Maintaining MEDI3902 Serum Levels Above the Target Level (1.7 µg/mL) Through 21 Days Post Dose
timeFrame: Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, and Day 22
measure: Terminal Elimination Half-life (t1/2) of MEDI3902
timeFrame: Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50
measure: Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI3902 Treatment
timeFrame: Day 1 (predose), Day 15, Day 29, Day 50
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Research Site
state: Colorado
city: Gainesville
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Augusta
country: United States
facility: Research Site
state: Georgia
city: Annapolis
country: United States
facility: Research Site
state: Maryland
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Detroit
country: United States
facility: Research Site
state: Michigan
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Innsbruck
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Bruges
country: Belgium
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Genk
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Haine-Saint-Paul
country: Belgium
facility: Research Site
city: Ottignies
country: Belgium
facility: Research Site
city: Slavonski Brod
country: Croatia
facility: Research Site
city: Brno
country: Czechia
facility: Research Site
city: Decin
country: Czechia
facility: Research Site
city: Kolin
country: Czechia
facility: Research Site
city: Kyjov
country: Czechia
facility: Research Site
city: Teplice
country: Czechia
facility: Research Site
city: Argenteuil
country: France
facility: Research Site
city: Clermont-ferrand
country: France
facility: Research Site
city: Garches
country: France
facility: Research Site
city: La Tronche
country: France
facility: Research Site
city: Le Kremlin Bicetre
country: France
facility: Research Site
city: Le Plessis Robinson
country: France
facility: Research Site
city: Lille Cedex
country: France
facility: Research Site
city: Limoges
country: France
facility: Research Site
city: Montpellier Cedex 5
country: France
facility: Research Site
city: Nancy
country: France
facility: Research Site
city: Paris Cedex 14
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Pierre Benite
country: France
facility: Research Site
city: Strasbourg
country: France
facility: Research Site
city: Tours
country: France
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Larissa
country: Greece
facility: Research Site
city: Larissa
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Kistarcsa
country: Hungary
facility: Research Site
city: Vác
country: Hungary
facility: Research Site
city: Dublin
country: Ireland
facility: Research Site
city: Jerusalem
country: Israel
facility: Research Site
city: Petach-Tikva
country: Israel
facility: Research Site
city: Ramat Gan
country: Israel
facility: Research Site
city: Tel Aviv
country: Israel
facility: Research Site
city: Almada
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Viana do Castelo
country: Portugal
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Cordoba
country: Spain
facility: Research Site
city: Getafe
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Oviedo
country: Spain
facility: Research Site
city: San Sebastián de los Reyes
country: Spain
facility: Research Site
city: Santander
country: Spain
facility: Research Site
city: Tarragona
country: Spain
facility: Research Site
city: Terrassa
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Valladolid
country: Spain
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Trabzon
country: Turkey
facility: Research Site
city: Edgbaston
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: MedImmune LLC
name: MedImmune LLC
role: STUDY_DIRECTOR
References:
citation: Chastre J, Francois B, Bourgeois M, Komnos A, Ferrer R, Rahav G, De Schryver N, Lepape A, Koksal I, Luyt CE, Sanchez-Garcia M, Torres A, Eggimann P, Koulenti D, Holland TL, Ali O, Shoemaker K, Ren P, Sauser J, Ruzin A, Tabor DE, Akhgar A, Wu Y, Jiang Y, DiGiandomenico A, Colbert S, Vandamme D, Coenjaerts F, Malhotra-Kumar S, Timbermont L, Oliver A, Barraud O, Bellamy T, Bonten M, Goossens H, Reisner C, Esser MT, Jafri HS; COMBACTE-MAGNET EVADE Study Group. Safety, efficacy, and pharmacokinetics of gremubamab (MEDI3902), an anti-Pseudomonas aeruginosa bispecific human monoclonal antibody, in P. aeruginosa-colonised, mechanically ventilated intensive care unit patients: a randomised controlled trial. Crit Care. 2022 Nov 15;26(1):355. doi: 10.1186/s13054-022-04204-9.