Study of the Efficacy and Safety of MEDI4893

Staphylococcus Aureus Pneumonia Clinical Trial

— SAATELLITE  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02296320
• Other study ID #: CD-ID-MEDI4893-1139
• Status: Completed
• Phase: Phase 2
• Start date: October 10, 2014
• Est. completion date: October 2, 2018

Study information

• Verified date: December 2019
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: October 2, 2018
• Est. primary completion date: October 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Staphylococcal
• Staphylococcus Aureus Pneumonia

Intervention

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.

Locations

Country	Name	City	State
Belgium	Research Site	Arlon
Belgium	Research Site	Bruxelles
Belgium	Research Site	La Louvière
Belgium	Research Site	Lodelinsart
Belgium	Research Site	Yvoir
Czechia	Research Site	Brno
Czechia	Research Site	Decin
Czechia	Research Site	Kyjov
Czechia	Research Site	Praha
Czechia	Research Site	Teplice
France	Research Site	Angers CEDEX 9
France	Research Site	Clermont-ferrand
France	Research Site	Garches
France	Research Site	Grenoble Cedex
France	Research Site	Le Chesnay
France	Research Site	Lille Cedex
France	Research Site	Limoges
France	Research Site	Lyon
France	Research Site	Nantes
France	Research Site	Orléans Cedex 2
France	Research Site	Pierre Benite Cedex
France	Research Site	Poitiers
France	Research Site	Rennes
France	Research Site	Tours
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Erfurt
Germany	Research Site	Heidelberg
Germany	Research Site	Jena
Greece	Research Site	Alexandroupolis
Greece	Research Site	Athens
Greece	Research Site	Ioannina
Greece	Research Site	Larissa
Greece	Research Site	Larissa
Hungary	Research Site	Kistarcsa
Hungary	Research Site	Vác
Portugal	Research Site	Ponte De Lima
Spain	Research Site	Barcelona
Spain	Research Site	Barcelona
Spain	Research Site	Getafe
Spain	Research Site	Madrid
Spain	Research Site	Oviedo
Spain	Research Site	Terrassa
Spain	Research Site	Valencia
Spain	Research Site	Valencia
Switzerland	Research Site	Geneva
Switzerland	Research Site	Lausanne
United States	Research Site	Atlanta	Georgia
United States	Research Site	Detroit	Michigan

Sponsors (4)

Lead Sponsor	Collaborator
MedImmune LLC	Antibacterial Resistance Leadership Group, Innovative Medicines Initiative and COMBACTE-NET, National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Belgium,  Czechia,  France,  Germany,  Greece,  Hungary,  Portugal,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Endpoint Adjudication Committee-Determined (EAC) Staphylococcus Aureus (S Aureus) Pneumonia	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).	Day 1 through Day 31
Primary	Number of Participants With Treatment Emergent Adverse Events (TEAEs) Through 31 Days	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.	Day 1 through Day 31
Primary	Number of Participants With TEAEs Through 91 Days	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.	Day 1 through Day 91
Primary	Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)	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.	Day 1 through Day 191
Primary	Number of Participants With Adverse Events of Special Interest (AESIs)	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.	Day 1 through Day 191
Primary	Number of Participants With New Onset Chronic Diseases (NOCDs)	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.	Day 1 through Day 191
Secondary	Maximum Observed Serum Concentration (Cmax) of MEDI4893	Maximum observed serum concentration (Cmax) of MEDI4893 is reported.	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
Secondary	Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC [0-Last]) of MEDI4893	Area under the serum concentration time curve from time zero to last measurable concentration (AUC[0 - Last]) of MEDI4893 is reported.	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
Secondary	Observed Serum Concentration of MEDI4893 Through 30 Days Post Dose (C30)	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).	Day 1 (Pre-dose, end of the infusion, 8 and 24 hours post dose), and on Days 4, 8, 15, 22, and 30
Secondary	Observed Serum Concentration of MEDI4893 Through 90 Days Post Dose (C90)	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).	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
Secondary	Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to MEDI4893	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.	Pre-dose on Day 1 (Baseline); and on Days 31, 61, and 91

External Links

•   CD-ID-MEDI4893-1139 Protocol amendment 5_redacted_FINAL_APPROVED
•   CD-ID-MEDI4893-1139 Statistical Analysis Plan_Final v4.0_Redacted_FINAL_APPROVED