Ticagrelor in Severe Community Acquired Pneumonia

NCT01998399 | Terminated Phase 2 Results DMC

• 1 other identifier: 131908
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 26

Brief Summary

The purpose of this study is to determine if the drug ticagrelor will be an effective treatment for patients with severe community acquired pneumonia. The primary objective is to reduce all-cause mortality in the ticagrelor group compared to the placebo group.

Conditions

Community Acquired Pneumonia, Severe

Keywords

CAP; Pneumonia; Intensive Care Unit; Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• All-cause Mortality

  death during 90 day study period

  90 days

Secondary Outcomes (7)

• Shock Free Days

  15 days

• Ventilator Free Days

  29 days

• In-hospital Mortality

  Throughout hospitalization (About 2 weeks)

• Hospital Free Days

  29 days

• Stroke

  90 days

Other Outcomes (6)

• Time to Initiation of Unassisted Breathing

  29 days

• Need for Re-instituting Assisted or Mechanical Ventilation After Achieving 48 Consecutive Hours of Unassisted Breathing or Comfort Care Chosen (Withdrawal of Support)

  90 days

• Need for Dialysis

  28 days

Study Arms (2)

Ticagrelor

EXPERIMENTAL

Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days

Drug: Ticagrelor

Placebo

PLACEBO COMPARATOR

Placebo 180 mg loading dose followed by 90 mg BID for 90 days.

Drug: Placebo

Interventions

Ticagrelor DRUG

Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days

Also known as: Brilinta

Ticagrelor

Placebo DRUG

Placebo 180 mg loading dose followed by 90 mg BID for 90 days.

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients will have new "severe" CAP as defined by
• a. New (within 72 hours of hospital admission) radiographic finding consistent with pneumonia and admission or planned admission to an ICU for: i. Mechanical Ventilation (invasive or non-invasive) OR ii. Vasopressors (dobutamine and phosphodiesterase are not considered vasopressors for this criteria) OR iii. ICU admission due to severe respiratory distress or arterial desaturation. b. At least two of the following; i. recent increase in dyspnea ii. increased sputum production iii. change of character of sputum iv. White Blood Cells \> 12,000 or \< 4,000 cells/mm3 or \>10% bands v. Body temperature \>38ºC or \<36ºC (any route)

You may not qualify if:

• Development of pneumonia after 72 hours of current hospitalization.
• Underlying disease likely to cause mortality within 90 days of randomization.
• A resident in a hospital, not nursing home, within 30 days prior to development of pneumonia.
• Patients who are moribund (not expected to live for more than 48 hours).
• No consent/inability to obtain consent from patient or surrogate.
• Patient's physician is unwilling to have patient enter the study.
• Age less than 50 years.
• Pregnancy.
• Breast feeding.
• Underlying immunodeficiency (e.g. HIV, neutropenia, active hematologic malignancy, functional or anatomical asplenia and hypogammaglobulinemia).
• Patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if he/she will receive all supportive care except for attempts at resuscitation from cardiac arrest).
• Unable to receive or unlikely to absorb enteral study drug (e.g., patients with partial or complete mechanical bowel obstruction, intestinal ischemia, infarction, and short bowel syndrome).
• Hepatic impairment
• a. Child Pugh score \> 7 using data from outpatient setting
• Conditions that increase the risk of bleeding, e.g.:

Sponsors & Collaborators

• Gordon Bernard: lead
• AstraZeneca: collaborator

Study Sites (26)

University of Arizona

Tucson, Arizona, 85724, United States

Location

University of Colorado

Colorado Springs, Colorado, 80909, United States

Location

Denver Health

Denver, Colorado, 80204, United States

Location

Atlanta VA Medical Center

Atlanta, Georgia, 30033, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

Moses Cone

Greensboro, North Carolina, 27401, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Legacy Good Samaritan Medical Center

Portland, Oregon, 97210, United States

Location

Legacy Emanuel Medical Center

Portland, Oregon, 97227, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97239, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Baylor

Houston, Texas, 77030, United States

Location

Memorial Hermann Hospital - Texas Medical Center

Houston, Texas, 77030, United States

Location

South Texas Veterans Health Care System

San Antonio, Texas, 78229, United States

Location

University of Texas Health Science Center San Antonio

San Antonio, Texas, 78229, United States

Location

Scott & White Memorial Hospital

Temple, Texas, 76508, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia; Pneumonia

Interventions

Ticagrelor

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Results Point of Contact

• Title: Gordon Bernard, Professor of Medicine, Associate Vice Chancellor for Research
• Organization: Vanderbilt University

gordon.bernard@Vanderbilt.Edu

615-343-0077

Study Officials

• Gordon R Bernard, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Jon D Truwit, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: November 15, 2013
• First Posted: November 28, 2013
• Study Start: August 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 11, 2017
• Results First Posted: March 11, 2016

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (26)