Study of the Efficacy and Safety of MEDI4893 (SAATELLITE)
Primary Purpose
Staphylococcus Aureus Pneumonia
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MEDI4893
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Staphylococcus Aureus Pneumonia
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.
Sites / Locations
- Research Site
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
Active Comparator
Arm Label
MEDI4893 5000 mg
Placebo
MEDI4893 2000 mg
Arm Description
Participants will receive a single intravenous (IV) dose of MEDI4893 5000 milligrams (mg) on Day 1 of the study.
Participants will receive a single IV dose of placebo matched to MEDI4893 on Day 1 of the study.
Participants will receive a single IV dose of MEDI4893 2000 mg on Day 1 of the study.
Outcomes
Primary Outcome Measures
Percentage of Participants With Endpoint Adjudication Committee-Determined (EAC) Staphylococcus Aureus (S Aureus) Pneumonia
The EAC S aureus pneumonia was based on clinical, radiographic, and microbiologic criteria. Clinical criteria: 1 major criteria (PaO2/FiO2 ratio < 240 mmHg maintained for at least 4 hours or decrease in PaO2/FiO2 by >= 50 mmHg maintained for at least 4 hrs or a need to initiate non-invasive mechanical ventilation or re-initiate invasive mechanical ventilation because of respiratory failure or worsening of respiratory status); and at least 2 of minor criteria (systemic signs of infection, production of purulent sputum/endotracheal secretions, new onset of cough, physical examination findings consistent with pneumonia/pulmonary consolidation, dyspnea, and/or tachypnea). Radiographic criteria: new or worsening infiltrate consistent with pneumonia on chest X-ray obtained within 24 hrs of event. Microbiologic criteria: at least 1 culture positive for S aureus (respiratory specimen, or blood, or pleural fluid aspirate or lung tissue culture during episode of pneumonia).
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Through 31 Days
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Number of Participants With TEAEs Through 91 Days
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)
A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Number of Participants With Adverse Events of Special Interest (AESIs)
An AESI is one of scientific and medical interest specific to understanding of the study drug and may have required close monitoring and rapid communication by the investigator to the sponsor. An AESI may have been serious or non-serious.
Number of Participants With New Onset Chronic Diseases (NOCDs)
An NOCD defined as a newly diagnosed medical condition that is of a chronic, ongoing nature. It is observed after receiving the study drug and is assessed by the investigator as medically significant.
Secondary Outcome Measures
Maximum Observed Serum Concentration (Cmax) of MEDI4893
Maximum observed serum concentration (Cmax) of MEDI4893 is reported.
Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC [0-Last]) of MEDI4893
Area under the serum concentration time curve from time zero to last measurable concentration (AUC[0 - Last]) of MEDI4893 is reported.
Observed Serum Concentration of MEDI4893 Through 30 Days Post Dose (C30)
Observed serum concentration of MEDI4893 through 30 days post dose (C30) is reported. Serum concentration of MEDI4893 through 30 days post dose accounted the overall concentration of MEDI4893 measured on specified time points (Days 1, 4, 8, 15, 22, and 30).
Observed Serum Concentration of MEDI4893 Through 90 Days Post Dose (C90)
Observed serum concentration of MEDI4893 through 90 days post dose (C90) is reported. Serum concentration of MEDI4893 through 90 days post dose accounted the overall concentration of MEDI4893 measured on specified time points (Days 1, 4, 8, 15, 22, 31, 61, and 91).
Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to MEDI4893
Participants with ADA-positive at any of Day 31, Day 61, or Day 91 post-baseline assessments were always counted as "positive" at post-baseline.
Full Information
NCT ID
NCT02296320
First Posted
October 30, 2014
Last Updated
December 11, 2019
Sponsor
MedImmune LLC
Collaborators
Innovative Medicines Initiative and COMBACTE-NET, Antibacterial Resistance Leadership Group, National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT02296320
Brief Title
Study of the Efficacy and Safety of MEDI4893
Acronym
SAATELLITE
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
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
October 10, 2014 (Actual)
Primary Completion Date
October 2, 2018 (Actual)
Study Completion Date
October 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedImmune LLC
Collaborators
Innovative Medicines Initiative and COMBACTE-NET, Antibacterial Resistance Leadership Group, National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Clinical trial looking at safety and efficacy of MEDI4893 in prevention of pneumonia caused by Staphylococcus aureus in high-risk patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcus Aureus Pneumonia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
213 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MEDI4893 5000 mg
Arm Type
Active Comparator
Arm Description
Participants will receive a single intravenous (IV) dose of MEDI4893 5000 milligrams (mg) on Day 1 of the study.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive a single IV dose of placebo matched to MEDI4893 on Day 1 of the study.
Arm Title
MEDI4893 2000 mg
Arm Type
Active Comparator
Arm Description
Participants will receive a single IV dose of MEDI4893 2000 mg on Day 1 of the study.
Intervention Type
Drug
Intervention Name(s)
MEDI4893
Intervention Description
Participants will receive a single IV dose of MEDI4893 2000 or 5000 mg on Day 1 of the study.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Participants will receive a single IV dose of placebo matched to MEDI4893 on Day 1 of the study.
Primary Outcome Measure Information:
Title
Percentage of Participants With Endpoint Adjudication Committee-Determined (EAC) Staphylococcus Aureus (S Aureus) Pneumonia
Description
The EAC S aureus pneumonia was based on clinical, radiographic, and microbiologic criteria. Clinical criteria: 1 major criteria (PaO2/FiO2 ratio < 240 mmHg maintained for at least 4 hours or decrease in PaO2/FiO2 by >= 50 mmHg maintained for at least 4 hrs or a need to initiate non-invasive mechanical ventilation or re-initiate invasive mechanical ventilation because of respiratory failure or worsening of respiratory status); and at least 2 of minor criteria (systemic signs of infection, production of purulent sputum/endotracheal secretions, new onset of cough, physical examination findings consistent with pneumonia/pulmonary consolidation, dyspnea, and/or tachypnea). Radiographic criteria: new or worsening infiltrate consistent with pneumonia on chest X-ray obtained within 24 hrs of event. Microbiologic criteria: at least 1 culture positive for S aureus (respiratory specimen, or blood, or pleural fluid aspirate or lung tissue culture during episode of pneumonia).
Time Frame
Day 1 through Day 31
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Through 31 Days
Description
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Time Frame
Day 1 through Day 31
Title
Number of Participants With TEAEs Through 91 Days
Description
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Time Frame
Day 1 through Day 91
Title
Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)
Description
A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Time Frame
Day 1 through Day 191
Title
Number of Participants With Adverse Events of Special Interest (AESIs)
Description
An AESI is one of scientific and medical interest specific to understanding of the study drug and may have required close monitoring and rapid communication by the investigator to the sponsor. An AESI may have been serious or non-serious.
Time Frame
Day 1 through Day 191
Title
Number of Participants With New Onset Chronic Diseases (NOCDs)
Description
An NOCD defined as a newly diagnosed medical condition that is of a chronic, ongoing nature. It is observed after receiving the study drug and is assessed by the investigator as medically significant.
Time Frame
Day 1 through Day 191
Secondary Outcome Measure Information:
Title
Maximum Observed Serum Concentration (Cmax) of MEDI4893
Description
Maximum observed serum concentration (Cmax) of MEDI4893 is reported.
Time Frame
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
Title
Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC [0-Last]) of MEDI4893
Description
Area under the serum concentration time curve from time zero to last measurable concentration (AUC[0 - Last]) of MEDI4893 is reported.
Time Frame
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
Title
Observed Serum Concentration of MEDI4893 Through 30 Days Post Dose (C30)
Description
Observed serum concentration of MEDI4893 through 30 days post dose (C30) is reported. Serum concentration of MEDI4893 through 30 days post dose accounted the overall concentration of MEDI4893 measured on specified time points (Days 1, 4, 8, 15, 22, and 30).
Time Frame
Day 1 (Pre-dose, end of the infusion, 8 and 24 hours post dose), and on Days 4, 8, 15, 22, and 30
Title
Observed Serum Concentration of MEDI4893 Through 90 Days Post Dose (C90)
Description
Observed serum concentration of MEDI4893 through 90 days post dose (C90) is reported. Serum concentration of MEDI4893 through 90 days post dose accounted the overall concentration of MEDI4893 measured on specified time points (Days 1, 4, 8, 15, 22, 31, 61, and 91).
Time Frame
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
Title
Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to MEDI4893
Description
Participants with ADA-positive at any of Day 31, Day 61, or Day 91 post-baseline assessments were always counted as "positive" at post-baseline.
Time Frame
Pre-dose on Day 1 (Baseline); and on Days 31, 61, and 91
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MedImmune LLC
Organizational Affiliation
MedImmune LLC
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Research Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Research Site
City
Arlon
ZIP/Postal Code
6700
Country
Belgium
Facility Name
Research Site
City
Bruxelles
Country
Belgium
Facility Name
Research Site
City
La Louvière
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Research Site
City
Lodelinsart
ZIP/Postal Code
6042
Country
Belgium
Facility Name
Research Site
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Research Site
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Research Site
City
Decin
ZIP/Postal Code
405 99
Country
Czechia
Facility Name
Research Site
City
Kyjov
ZIP/Postal Code
697 01
Country
Czechia
Facility Name
Research Site
City
Praha
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Research Site
City
Teplice
ZIP/Postal Code
415 29
Country
Czechia
Facility Name
Research Site
City
Angers CEDEX 9
ZIP/Postal Code
49933
Country
France
Facility Name
Research Site
City
Clermont-ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Research Site
City
Garches
ZIP/Postal Code
92380
Country
France
Facility Name
Research Site
City
Grenoble Cedex
ZIP/Postal Code
38043
Country
France
Facility Name
Research Site
City
Le Chesnay
ZIP/Postal Code
78157
Country
France
Facility Name
Research Site
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Research Site
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Research Site
City
Lyon
ZIP/Postal Code
69394
Country
France
Facility Name
Research Site
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Research Site
City
Orléans Cedex 2
ZIP/Postal Code
45100
Country
France
Facility Name
Research Site
City
Pierre Benite Cedex
ZIP/Postal Code
69495
Country
France
Facility Name
Research Site
City
Poitiers
ZIP/Postal Code
86201
Country
France
Facility Name
Research Site
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Research Site
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
12351
Country
Germany
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Research Site
City
Erfurt
ZIP/Postal Code
99089
Country
Germany
Facility Name
Research Site
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Research Site
City
Jena
ZIP/Postal Code
07740
Country
Germany
Facility Name
Research Site
City
Alexandroupolis
ZIP/Postal Code
68100
Country
Greece
Facility Name
Research Site
City
Athens
ZIP/Postal Code
14564
Country
Greece
Facility Name
Research Site
City
Ioannina
ZIP/Postal Code
455 00
Country
Greece
Facility Name
Research Site
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Facility Name
Research Site
City
Larissa
ZIP/Postal Code
41221
Country
Greece
Facility Name
Research Site
City
Kistarcsa
ZIP/Postal Code
02143
Country
Hungary
Facility Name
Research Site
City
Vác
ZIP/Postal Code
2600
Country
Hungary
Facility Name
Research Site
City
Ponte De Lima
ZIP/Postal Code
4990-041
Country
Portugal
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Research Site
City
Getafe
ZIP/Postal Code
28905
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Research Site
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Facility Name
Research Site
City
Terrassa
ZIP/Postal Code
08221
Country
Spain
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Research Site
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Research Site
City
Lausanne
ZIP/Postal Code
CH-1011
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
33894131
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.
Results Reference
derived
PubMed Identifier
27795368
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.
Results Reference
derived
Links:
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=CD-ID-MEDI4893-1139&attachmentIdentifier=516e4676-ac10-48ef-8f1b-f2c3bacfc92f&fileName=CD-ID-MEDI4893-1139_Protocol_amendment_5_redacted_FINAL_APPROVED.pdf&versionIdentifier=
Description
CD-ID-MEDI4893-1139 Protocol amendment 5_redacted_FINAL_APPROVED
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=CD-ID-MEDI4893-1139&attachmentIdentifier=3b2d9a7a-eaa9-4651-be9d-7271be664bb1&fileName=CD-ID-MEDI4893-1139_Statistical_Analysis_Plan_Final_v4.0_Redacted_FINAL_APPROVED.pdf&versionIdentifier=
Description
CD-ID-MEDI4893-1139 Statistical Analysis Plan_Final v4.0_Redacted_FINAL_APPROVED
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Study of the Efficacy and Safety of MEDI4893
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