Ticagrelor in Severe Community Acquired Pneumonia

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Community Acquired Pneumonia, Severe

In brief

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.

Key facts

Study ID

NCT01998399

Run by

Gordon Bernard

People needed

25

Starts

2014-08-01

Expected to finish

2015-12-01

Last updated by the study team

2017-12-11

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

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…

• More than 72 hours have passed since meeting required inclusion criteria.
• 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.:
• Surgery or the likely need for surgery during study, or evidence of active bleeding postoperatively (ICU procedures such as line placement, tracheostomy and chest tubes are not to be considered for this exclusion);
• A history of severe head trauma requiring hospitalization or intra-cranial surgery within 3 months;
• Any history of intracerebral arteriovenous malformation, cerebral aneurysm, or mass lesions of the central nervous system, hemorrhagic stroke or intracranial hemorrhage, or congenital bleeding diathesis;
• Gastrointestinal bleeding within 6 weeks before the study unless a corrective procedure has been performed;
• Recent trauma considered to increase the risk of bleeding.
• Chronic renal disease requiring renal replacement therapy.
• Creatinine > 3 mg/dL.
• Platelet count < 50,000 /mm3.
• Use of a P2Y12 inhibitor within the 3 months prior to randomization or physician intent to initiate one of the CYP3A inhibitors, e.g. ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, atazanovir, saquinavir, nelfinavir, indinavir, or telithromycin.

Where it is running

• University of Arizona — Tucson, Arizona, United States
• University of Colorado — Colorado Springs, Colorado, United States
• Denver Health — Denver, Colorado, United States
• Atlanta VA Medical Center — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• University of Kentucky — Lexington, Kentucky, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• Regions Hospital — Saint Paul, Minnesota, United States
• Moses Cone — Greensboro, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• The Ohio State University — Columbus, Ohio, United States
• Legacy Good Samaritan Medical Center — Portland, Oregon, United States
• Legacy Emanuel Medical Center — Portland, Oregon, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Baylor — Houston, Texas, United States
• Memorial Hermann Hospital - Texas Medical Center — Houston, Texas, United States
• South Texas Veterans Health Care System — San Antonio, Texas, United States
• University of Texas Health Science Center San Antonio — San Antonio, Texas, United States
• Scott & White Memorial Hospital — Temple, Texas, United States
• Intermountain Medical Center — Murray, Utah, United States
• University of Utah — Salt Lake City, Utah, United States
• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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