Clinical trial NCT02296320: Study of the Efficacy and Safety of MEDI4893
Official title: A Phase 2 Randomised, Double-blind, Placebo-controlled, Single-dose, Dose-ranging Study of the Efficacy and Safety of MEDI4893, a Human Monoclonal Antibody Against Staphylococcus Aureus Alpha Toxin in Mechanically Ventilated Adult Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Staphylococcus Aureus 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: 2014-11-20
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Clinical trial looking at safety and efficacy of MEDI4893 in prevention of pneumonia caused by Staphylococcus aureus in high-risk patients


Eligibility criteria: Inclusion Criteria:

* Colonized with Staphylococcus aureus, expected to require prolonged intubation and mechanical ventilation, without any evidence of active pneumonia.

Exclusion Criteria:

* Staphylococcal disease at randomisation; lung injury score consistent with pneumonia; current lung disease; chronic tracheostomy patients; currently receiving systemic anti-staphylococcal antibiotics; moribund patients.

Primary outcomes:
measure: Percentage of Participants With Endpoint Adjudication Committee-Determined (EAC) Staphylococcus Aureus (S Aureus) Pneumonia
timeFrame: Day 1 through Day 31
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Through 31 Days
timeFrame: Day 1 through Day 31
measure: Number of Participants With TEAEs Through 91 Days
timeFrame: Day 1 through Day 91
measure: Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)
timeFrame: Day 1 through Day 191
measure: Number of Participants With Adverse Events of Special Interest (AESIs)
timeFrame: Day 1 through Day 191
measure: Number of Participants With New Onset Chronic Diseases (NOCDs)
timeFrame: Day 1 through Day 191
Secondary outcomes:
measure: Maximum Observed Serum Concentration (Cmax) of MEDI4893
timeFrame: Day 1 (Pre-dose, end of the infusion, 8 and 24 hours post dose), and on Days 4, 8, 15, 22, 31, 61, and 91
measure: Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC [0-Last]) of MEDI4893
timeFrame: Day 1 (Pre-dose, end of the infusion, 8 and 24 hours post dose), and on Days 4, 8, 15, 22, 31, 61, and 91
measure: Observed Serum Concentration of MEDI4893 Through 30 Days Post Dose (C30)
timeFrame: Day 1 (Pre-dose, end of the infusion, 8 and 24 hours post dose), and on Days 4, 8, 15, 22, and 30
measure: Observed Serum Concentration of MEDI4893 Through 90 Days Post Dose (C90)
timeFrame: Day 1 (Pre-dose, end of the infusion, 8 and 24 hours post dose), and on Days 4, 8, 15, 22, 31, 61, and 90
measure: Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to MEDI4893
timeFrame: Pre-dose on Day 1 (Baseline); and on Days 31, 61, and 91
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Detroit
country: United States
facility: Research Site
state: Michigan
city: Arlon
country: Belgium
facility: Research Site
city: Bruxelles
country: Belgium
facility: Research Site
city: La Louvière
country: Belgium
facility: Research Site
city: Lodelinsart
country: Belgium
facility: Research Site
city: Yvoir
country: Belgium
facility: Research Site
city: Brno
country: Czechia
facility: Research Site
city: Decin
country: Czechia
facility: Research Site
city: Kyjov
country: Czechia
facility: Research Site
city: Praha
country: Czechia
facility: Research Site
city: Teplice
country: Czechia
facility: Research Site
city: Angers CEDEX 9
country: France
facility: Research Site
city: Clermont-ferrand
country: France
facility: Research Site
city: Garches
country: France
facility: Research Site
city: Grenoble Cedex
country: France
facility: Research Site
city: Le Chesnay
country: France
facility: Research Site
city: Lille Cedex
country: France
facility: Research Site
city: Limoges
country: France
facility: Research Site
city: Lyon
country: France
facility: Research Site
city: Nantes
country: France
facility: Research Site
city: Orléans Cedex 2
country: France
facility: Research Site
city: Pierre Benite Cedex
country: France
facility: Research Site
city: Poitiers
country: France
facility: Research Site
city: Rennes
country: France
facility: Research Site
city: Tours
country: France
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Erfurt
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Jena
country: Germany
facility: Research Site
city: Alexandroupolis
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Ioannina
country: Greece
facility: Research Site
city: Larissa
country: Greece
facility: Research Site
city: Larissa
country: Greece
facility: Research Site
city: Kistarcsa
country: Hungary
facility: Research Site
city: Vác
country: Hungary
facility: Research Site
city: Ponte De Lima
country: Portugal
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
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: Terrassa
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Geneva
country: Switzerland
facility: Research Site
city: Lausanne
country: Switzerland
facility: Research Site
Study officials:
affiliation: MedImmune LLC
name: MedImmune LLC
role: STUDY_DIRECTOR
References:
citation: Francois B, Jafri HS, Chastre J, Sanchez-Garcia M, Eggimann P, Dequin PF, Huberlant V, Vina Soria L, Boulain T, Bretonniere C, Pugin J, Trenado J, Hernandez Padilla AC, Ali O, Shoemaker K, Ren P, Coenjaerts FE, Ruzin A, Barraud O, Timbermont L, Lammens C, Pierre V, Wu Y, Vignaud J, Colbert S, Bellamy T, Esser MT, Dubovsky F, Bonten MJ, Goossens H, Laterre PF; COMBACTE Consortium and the SAATELLITE Study Group. Efficacy and safety of suvratoxumab for prevention of Staphylococcus aureus ventilator-associated pneumonia (SAATELLITE): a multicentre, randomised, double-blind, placebo-controlled, parallel-group, phase 2 pilot trial. Lancet Infect Dis. 2021 Sep;21(9):1313-1323. doi: 10.1016/S1473-3099(20)30995-6. Epub 2021 Apr 21.
citation: Yu XQ, Robbie GJ, Wu Y, Esser MT, Jensen K, Schwartz HI, Bellamy T, Hernandez-Illas M, Jafri HS. Safety, Tolerability, and Pharmacokinetics of MEDI4893, an Investigational, Extended-Half-Life, Anti-Staphylococcus aureus Alpha-Toxin Human Monoclonal Antibody, in Healthy Adults. Antimicrob Agents Chemother. 2016 Dec 27;61(1):e01020-16. doi: 10.1128/AAC.01020-16. Print 2017 Jan.