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Study of the Efficacy and Safety of MEDI4893

NCT ID: NCT02296320

Last Updated: 2019-12-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

213 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-10

Study Completion Date

2018-10-02

Brief Summary

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

Detailed Description

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Conditions

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Staphylococcus Aureus Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MEDI4893 5000 mg

Participants will receive a single intravenous (IV) dose of MEDI4893 5000 milligrams (mg) on Day 1 of the study.

Group Type ACTIVE_COMPARATOR

MEDI4893

Intervention Type DRUG

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

Placebo

Participants will receive a single IV dose of placebo matched to MEDI4893 on Day 1 of the study.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Participants will receive a single IV dose of placebo matched to MEDI4893 on Day 1 of the study.

MEDI4893 2000 mg

Participants will receive a single IV dose of MEDI4893 2000 mg on Day 1 of the study.

Group Type ACTIVE_COMPARATOR

MEDI4893

Intervention Type DRUG

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

Interventions

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MEDI4893

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

Intervention Type DRUG

Placebo

Participants will receive a single IV dose of placebo matched to MEDI4893 on Day 1 of the study.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Innovative Medicines Initiative

OTHER

Sponsor Role collaborator

Antibacterial Resistance Leadership Group

OTHER

Sponsor Role collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

MedImmune LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MedImmune LLC

Role: STUDY_DIRECTOR

MedImmune LLC

Locations

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Research Site

Atlanta, Georgia, United States

Site Status

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Detroit, Michigan, United States

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Arlon, , Belgium

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Brussels, , Belgium

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La Louvière, , Belgium

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Lodelinsart, , Belgium

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Yvoir, , Belgium

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Brno, , Czechia

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Děčín, , Czechia

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Kyjov, , Czechia

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Prague, , Czechia

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Teplice, , Czechia

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Angers, , France

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Clermont-Ferrand, , France

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Garches, , France

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Grenoble, , France

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Le Chesnay, , France

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Lille, , France

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Limoges, , France

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Lyon, , France

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Nantes, , France

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Orléans, , France

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Pierre-Bénite, , France

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Poitiers, , France

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Rennes, , France

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Tours, , France

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Berlin, , Germany

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Berlin, , Germany

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Erfurt, , Germany

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Heidelberg, , Germany

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Jena, , Germany

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Alexandroupoli, , Greece

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Athens, , Greece

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Ioannina, , Greece

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Larissa, , Greece

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Larissa, , Greece

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Kistarcsa, , Hungary

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Vác, , Hungary

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Ponte de Lima, , Portugal

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Barcelona, , Spain

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Barcelona, , Spain

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Getafe, , Spain

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Madrid, , Spain

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Oviedo, , Spain

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Terrassa, , Spain

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Valencia, , Spain

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Valencia, , Spain

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Geneva, , Switzerland

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Lausanne, , Switzerland

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Countries

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Ireland Turkey (Türkiye) United Kingdom United States Belgium Czechia France Germany Greece Hungary Portugal Spain Switzerland

References

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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.

Reference Type DERIVED
PMID: 33894131 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27795368 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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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=

CD-ID-MEDI4893-1139 Protocol amendment 5\_redacted\_FINAL\_APPROVED

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=

CD-ID-MEDI4893-1139 Statistical Analysis Plan\_Final v4.0\_Redacted\_FINAL\_APPROVED

Other Identifiers

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CD-ID-MEDI4893-1139

Identifier Type: -

Identifier Source: org_study_id