Community Acquired Pneumonia, Severe Clinical Trial
— TCAPOfficial title:
Randomized Trial of Ticagrelor for Severe Community Acquired Pneumonia
| Verified date | November 2017 |
| Source | Vanderbilt University Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 25 |
| Est. completion date | December 2015 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 50 Years and older |
| Eligibility |
Inclusion Criteria: 1. 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) Exclusion Criteria: 1. More than 72 hours have passed since meeting required inclusion criteria. 2. Development of pneumonia after 72 hours of current hospitalization. 3. Underlying disease likely to cause mortality within 90 days of randomization. 4. A resident in a hospital, not nursing home, within 30 days prior to development of pneumonia. 5. Patients who are moribund (not expected to live for more than 48 hours). 6. No consent/inability to obtain consent from patient or surrogate. 7. Patient's physician is unwilling to have patient enter the study. 8. Age less than 50 years. 9. Pregnancy. 10. Breast feeding. 11. Underlying immunodeficiency (e.g. HIV, neutropenia, active hematologic malignancy, functional or anatomical asplenia and hypogammaglobulinemia). 12. 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). 13. 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). 14. Hepatic impairment a. Child Pugh score > 7 using data from outpatient setting 15. Conditions that increase the risk of bleeding, e.g.: 1. 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); 2. A history of severe head trauma requiring hospitalization or intra-cranial surgery within 3 months; 3. 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; 4. Gastrointestinal bleeding within 6 weeks before the study unless a corrective procedure has been performed; 5. Recent trauma considered to increase the risk of bleeding. 16. Chronic renal disease requiring renal replacement therapy. 17. Creatinine > 3 mg/dL. 18. Platelet count < 50,000 /mm3. 19. 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. 20. Use of CYP3A inducers, e.g. rifampin, phenytoin, carbamazepine and phenobarbital. 21. Simvastatin or Lovastatin doses > 40 mg per day. 22. Digoxin use. 23. Receiving aspirin and physician and/or patient unwilling to reduce aspirin dose to <100 mg per day. 24. Daily Non-steroidal anti-inflammatory drugs (NSAID) use as an outpatient (other than Aspirin (ASA) as above). 25. Sick Sinus Syndrome, 2nd or 3rd degree heart block, bradycardia induced syncope - unless pacemaker in place. 26. Otherwise unsuitable for participation in the opinion of the investigator (i.e., homeless, non-compliant, etc.). |
| Country | Name | City | State |
|---|---|---|---|
| United States | Atlanta VA Medical Center | Atlanta | Georgia |
| United States | University of Maryland Medical Center | Baltimore | Maryland |
| United States | University of Virginia | Charlottesville | Virginia |
| United States | Northwestern University | Chicago | Illinois |
| United States | Cleveland Clinic | Cleveland | Ohio |
| United States | University of Colorado | Colorado Springs | Colorado |
| United States | The Ohio State University | Columbus | Ohio |
| United States | Denver Health | Denver | Colorado |
| United States | Moses Cone | Greensboro | North Carolina |
| United States | Baylor | Houston | Texas |
| United States | Memorial Hermann Hospital - Texas Medical Center | Houston | Texas |
| United States | University of Kentucky | Lexington | Kentucky |
| United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
| United States | Intermountain Medical Center | Murray | Utah |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | Legacy Emanuel Medical Center | Portland | Oregon |
| United States | Legacy Good Samaritan Medical Center | Portland | Oregon |
| United States | Oregon Health Sciences University | Portland | Oregon |
| United States | Rhode Island Hospital | Providence | Rhode Island |
| United States | Regions Hospital | Saint Paul | Minnesota |
| United States | University of Utah | Salt Lake City | Utah |
| 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 | Baystate Medical Center | Springfield | Massachusetts |
| United States | Scott & White Memorial Hospital | Temple | Texas |
| United States | University of Arizona | Tucson | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| Gordon Bernard | AstraZeneca |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Time to Initiation of Unassisted Breathing | Only in patients on mechanical ventilation and assuming patient achieves 48 consecutive hours of unassisted breathing | 29 days | |
| Other | 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 | ||
| Other | Need for Dialysis | 28 days | ||
| Other | ICU Length of Stay | Includes ICU readmission if during same hospital stay | 29 days | |
| Other | Hospital Length of Stay | In days | 29 days | |
| Other | Discharge Disposition | (Home, other facility, with or without assisted ventilation) | 90 days | |
| Primary | All-cause Mortality | death during 90 day study period | 90 days | |
| Secondary | Shock Free Days | Not requiring pressor support for hypotension | 15 days | |
| Secondary | Ventilator Free Days | 29 days | ||
| Secondary | In-hospital Mortality | Did the patient die during the hospitalization? | Throughout hospitalization (About 2 weeks) | |
| Secondary | Hospital Free Days | Number of days the patient is not in the hospital | 29 days | |
| Secondary | Stroke | Did the patient develop a stroke during the 90 day study? | 90 days | |
| Secondary | Stroke, Myocardial Infarct, Mortality | number of participants that suffered stroke, myocardial infarct, mortality | 90 days | |
| Secondary | Myocardial Infarction | Did the patient have a myocardial infarction during the 90 day study? | 90 days |