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Study of the Efficacy and Safety of MEDI4893 (SAATELLITE)

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ClinicalTrials.gov Identifier: NCT02296320
Recruitment Status : Active, not recruiting
First Posted : November 20, 2014
Last Update Posted : September 24, 2018
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 Drug: MEDI4893 low dose Phase 2

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
Estimated Primary Completion Date : December 3, 2018
Estimated Study Completion Date : December 3, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Active Comparator: MEDI4893 high dose Drug: MEDI4893
MEDI4893 (high dose)

Placebo Comparator: Placebo Other: Placebo
Placebo

Active Comparator: MEDI4893 low dose Drug: MEDI4893 low dose



Primary Outcome Measures :
  1. Safety of single intravenous (IV) doses of MEDI4893 as measured by adverse events. [ Time Frame: Subjects will be followed through Day 91 for adverse events and through Day 191 for serious adverse events ]
    Safety of MEDI4893 as measured by adverse events.

  2. Efficacy of single intravenous (IV) doses of MEDI4893 as measured by clinical symptoms of pneumonia. [ Time Frame: Incidence of Staphylococcus aureus pneumonia through Day 31 ]
    Efficacy of MEDI4893 as measured by clinical symptoms of Staphylococcus aureus pneumonia.


Secondary Outcome Measures :
  1. Single-dose pharmacokinetic (PK) parameters of MEDI4893 in serum. [ Time Frame: Subjects will be followed through Day 91 for PK ]
    Cmax

  2. 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

  3. Single-dose pharmacokinetic (PK) parameters of MEDI4893 in serum. [ Time Frame: Subjects will be followed through Day 91 for PK ]
    Tmax

  4. Single-dose pharmacokinetic (PK) parameters of MEDI4893 in serum. [ Time Frame: Subjects will be followed through Day 91 for PK ]
    t1/2

  5. Single-dose pharmacokinetic (PK) parameters of MEDI4893 in serum. [ Time Frame: Subjects will be followed through Day 91 for PK ]
    AUC



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (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


  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
Study Director: MedImmune LLC MedImmune LLC

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT02296320     History of Changes
Other Study ID Numbers: CD-ID-MEDI4893-1139
First Posted: November 20, 2014    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Staphylococcal
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Pneumonia, Bacterial