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Trial record 1 of 1 for:    NCT02296320
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Study of the Efficacy and Safety of MEDI4893 (SAATELLITE)

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ClinicalTrials.gov Identifier: NCT02296320
Recruitment Status : Completed
First Posted : November 20, 2014
Results First Posted : October 25, 2019
Last Update Posted : December 23, 2019
Sponsor:
Collaborators:
Innovative Medicines Initiative and COMBACTE-NET
Antibacterial Resistance Leadership Group
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
MedImmune LLC

Tracking Information
First Submitted Date  ICMJE October 30, 2014
First Posted Date  ICMJE November 20, 2014
Results First Submitted Date  ICMJE October 1, 2019
Results First Posted Date  ICMJE October 25, 2019
Last Update Posted Date December 23, 2019
Actual Study Start Date  ICMJE October 10, 2014
Actual Primary Completion Date October 2, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2019)
  • Percentage of Participants With Endpoint Adjudication Committee-Determined (EAC) Staphylococcus Aureus (S Aureus) Pneumonia [ Time Frame: Day 1 through Day 31 ]
    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 [ Time Frame: Day 1 through Day 31 ]
    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 [ Time Frame: Day 1 through Day 91 ]
    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) [ Time Frame: Day 1 through Day 191 ]
    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) [ Time Frame: Day 1 through Day 191 ]
    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) [ Time Frame: Day 1 through Day 191 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 17, 2014)
  • Safety of single intravenous (IV) doses of MEDI4893 as measured by adverse events and clinical laboratory parameters.. [ Time Frame: Subjects will be followed through Day 91 for adverse events and through Day 361 for serious adverse events ]
    Safety of MEDI4893 as measured by adverse events and clinical laboratory parameters.
  • Efficacy of single intravenous (IV) doses of MEDI4893 as measured by clinical symptoms of pneumonia and other Staphylococcus serious infection. [ Time Frame: Incidence of Staphylococcus aureus pneumonia through Day 31 ]
    Efficacy of MEDI4893 as measured by clinical symptoms of pneumonia and other Staphylococcus serious infection
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2019)
  • Maximum Observed Serum Concentration (Cmax) of MEDI4893 [ 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 ]
    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 [ 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 ]
    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) [ 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 ]
    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) [ 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 ]
    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 [ Time Frame: Pre-dose on Day 1 (Baseline); and on Days 31, 61, and 91 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2014)
  • Single-dose pharmacokinetic (PK) parameters of MEDI4893 in serum. [ Time Frame: Subjects will be followed through Day 91 for PK ]
    Cmax
  • Anti-drug Antibody (ADA) responses to MEDI4893 in serum [ Time Frame: Subjects will be followed through Day 91 for ADA ]
    Incidence and titers of ADA to MEDI4893 in serum
  • Single-dose pharmacokinetic (PK) parameters of MEDI4893 in serum. [ Time Frame: Subjects will be followed through Day 91 for PK ]
    Tmax
  • Single-dose pharmacokinetic (PK) parameters of MEDI4893 in serum. [ Time Frame: Subjects will be followed through Day 91 for PK ]
    t1/2
  • Single-dose pharmacokinetic (PK) parameters of MEDI4893 in serum. [ Time Frame: Subjects will be followed through Day 91 for PK ]
    AUC
  • Incidence of Staphylococcus aureus pneumonia on mechanical ventilation Measured by clinical symptoms of pneumonia and other Staphylococcus serious infection. [ Time Frame: Subjects will be followed through Day 31 for Staphylococcus aureus pneumonia ]
    Measured by clinical symptoms of pneumonia and other Staphylococcus serious infection
  • Incidence of Staphylococcus aureus pneumonia after mechanical ventilation no longer required Measured by clinical symptoms of pneumonia and other Staphylococcus serious infection. [ Time Frame: Subjects will be followed through Day 31 for Staphylococcus aureus pneumonia ]
    Measured by clinical symptoms of pneumonia and other Staphylococcus serious infection
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Efficacy and Safety of MEDI4893
Official Title  ICMJE 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.
Brief Summary Clinical trial looking at safety and efficacy of MEDI4893 in prevention of pneumonia caused by Staphylococcus aureus in high-risk patients
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Staphylococcus Aureus Pneumonia
Intervention  ICMJE
  • Drug: MEDI4893
    Participants will receive a single IV dose of MEDI4893 2000 or 5000 mg on Day 1 of the study.
  • Other: Placebo
    Participants will receive a single IV dose of placebo matched to MEDI4893 on Day 1 of the study.
Study Arms  ICMJE
  • Active Comparator: MEDI4893 5000 mg
    Participants will receive a single intravenous (IV) dose of MEDI4893 5000 milligrams (mg) on Day 1 of the study.
    Intervention: Drug: MEDI4893
  • Placebo Comparator: Placebo
    Participants will receive a single IV dose of placebo matched to MEDI4893 on Day 1 of the study.
    Intervention: Other: Placebo
  • Active Comparator: MEDI4893 2000 mg
    Participants will receive a single IV dose of MEDI4893 2000 mg on Day 1 of the study.
    Intervention: Drug: MEDI4893
Publications * 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). pii: e01020-16. doi: 10.1128/AAC.01020-16. Print 2017 Jan.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 4, 2018)
213
Original Estimated Enrollment  ICMJE
 (submitted: November 17, 2014)
462
Actual Study Completion Date  ICMJE October 2, 2018
Actual Primary Completion Date October 2, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 130 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Czechia,   France,   Germany,   Greece,   Hungary,   Portugal,   Spain,   Switzerland,   United States
Removed Location Countries Czech Republic,   Ireland,   Turkey,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT02296320
Other Study ID Numbers  ICMJE CD-ID-MEDI4893-1139
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MedImmune LLC
Study Sponsor  ICMJE MedImmune LLC
Collaborators  ICMJE
  • Innovative Medicines Initiative and COMBACTE-NET
  • Antibacterial Resistance Leadership Group
  • National Institute of Allergy and Infectious Diseases (NIAID)
Investigators  ICMJE
Study Director: MedImmune LLC MedImmune LLC
PRS Account MedImmune LLC
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP