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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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

Condition or disease Intervention/treatment Phase
Staphylococcus Aureus Pneumonia Drug: MEDI4893 Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 213 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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.
Actual Study Start Date : October 10, 2014
Actual Primary Completion Date : October 2, 2018
Actual Study Completion Date : October 2, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Active Comparator: MEDI4893 5000 mg
Participants will receive a single intravenous (IV) dose of MEDI4893 5000 milligrams (mg) on Day 1 of the study.
Drug: MEDI4893
Participants will receive a single IV dose of MEDI4893 2000 or 5000 mg on Day 1 of the study.

Placebo Comparator: Placebo
Participants will receive a single IV dose of placebo matched to MEDI4893 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.

Active Comparator: MEDI4893 2000 mg
Participants will receive a single IV dose of MEDI4893 2000 mg on Day 1 of the study.
Drug: MEDI4893
Participants will receive a single IV dose of MEDI4893 2000 or 5000 mg on Day 1 of the study.




Primary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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).

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02296320


Locations
Show Show 49 study locations
Sponsors and Collaborators
MedImmune LLC
Innovative Medicines Initiative and COMBACTE-NET
Antibacterial Resistance Leadership Group
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Study Director: MedImmune LLC MedImmune LLC
  Study Documents (Full-Text)

Documents provided by MedImmune LLC:
Study Protocol  [PDF] March 15, 2018
Statistical Analysis Plan  [PDF] September 7, 2018

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT02296320    
Other Study ID Numbers: CD-ID-MEDI4893-1139
First Posted: November 20, 2014    Key Record Dates
Results First Posted: October 25, 2019
Last Update Posted: December 23, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia, Staphylococcal
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Pneumonia, Bacterial