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

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 - SAATELLITE

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-001097-34-BE

Enrollment

462

Registered

2014-06-19

Start date

2014-09-08

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of Staphyloccus aureus pneumonia MedDRA version: 17.0 Level: LLT Classification code 10041942 Term: Staphylococcus aureus pneumonia System Organ Class: 100000004862

Interventions

Product Name: MEDI4893 Product Code: MEDI4893 Pharmaceutical Form: Solution for infusion INN or Proposed INN: NA CAS Number: NA Current Sponsor code: MEDI4893 Other descriptive name: MEDI4893 Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Colonized with S aureus , expected to require prolonged intubation and mechanical ventilation, without any evidence of active pneumonia. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 231 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 231

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: • To evaluate the effect of MEDI4893 in reducing the incidence of S aureus pneumonia • To evaluate the safety of a single IV dose of MEDI4893;Secondary Objective: • To evaluate the serum pharmacokinetics (PK) of MEDI4893 • To evaluate the serum anti-drug antibody (ADA) responses to MEDI4893 • To evaluate the effect of MEDI4893 in reducing the incidence of S aureus pneumonia by mechanical ventilation status;Primary end point(s): 1. Incidence of S aureus pneumonia 2. Safety of MEDI4893;Timepoint(s) of evaluation of this end point: 1. 30 Days post dose 2. TEAEs through 30 days and 90 days post dose, TESAEs, AESIs, NOCDs through 360 days post dose.	—

Measure

Time frame

Main Objective: • To evaluate the effect of MEDI4893 in reducing the incidence of S aureus pneumonia • To evaluate the safety of a single IV dose of MEDI4893;Secondary Objective: • To evaluate the serum pharmacokinetics (PK) of MEDI4893 • To evaluate the serum anti-drug antibody (ADA) responses to MEDI4893 • To evaluate the effect of MEDI4893 in reducing the incidence of S aureus pneumonia by mechanical ventilation status;Primary end point(s): 1. Incidence of S aureus pneumonia 2. Safety of MEDI4893;Timepoint(s) of evaluation of this end point: 1. 30 Days post dose 2. TEAEs through 30 days and 90 days post dose, TESAEs, AESIs, NOCDs through 360 days post dose.

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Secondary

Measure	Time frame
Secondary end point(s): • MEDI4893 serum PK • MEDI4893 ADA response in serum • Incidence of S aureus pneumonia on mechanical ventilation • Incidence of S aureus pneumonia after extubation;Timepoint(s) of evaluation of this end point: • Serum PK and ADA: 90 days • S aureus pneumonia: 30 days	—

Countries

Belgium, Czech Republic, Germany, Greece, Hungary, Ireland, Portugal, Spain, Switzerland, United Kingdom

Contacts

Public ContactClinical Trial Enquiries

MedImmune

clinicaltrialenquiries@medimmune.com001 301 398 0000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 20, 2026