Community Acquired Pneumonia, SeverePhase 2TCAPNCT01998399
Ticagrelor in Severe Community Acquired Pneumonia
A Phase 2 study testing Ticagrelor in people with Community Acquired Pneumonia, Severe, run by Gordon Bernard at 26 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Community Acquired Pneumonia, Severe
- What is being tested?
- Ticagrelor
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 26 sitesUnited States
- Study dates
- Aug 2014to Dec 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients will have new "severe" CAP as defined by
- 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)
Who cannot join
- 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.
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- 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
- 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.
- Use of CYP3A inducers, e.g. rifampin, phenytoin, carbamazepine and phenobarbital.
- Simvastatin or Lovastatin doses > 40 mg per day.
- Digoxin use.
- Receiving aspirin and physician and/or patient unwilling to reduce aspirin dose to <100 mg per day.
- Daily Non-steroidal anti-inflammatory drugs (NSAID) use as an outpatient (other than Aspirin (ASA) as above).
- Sick Sinus Syndrome, 2nd or 3rd degree heart block, bradycardia induced syncope - unless pacemaker in place.
- Otherwise unsuitable for participation in the opinion of the investigator (i.e., homeless, non-compliant, etc.).
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Atlanta VA Medical Center
Atlanta, Georgia, 30033
University of Maryland Medical Center
Baltimore, Maryland, 21201
University of Virginia
Charlottesville, Virginia, 22908
Northwestern University
Chicago, Illinois, 60611
Cleveland Clinic
Cleveland, Ohio, 44195
University of Colorado
Colorado Springs, Colorado, 80909
The Ohio State University
Columbus, Ohio, 43210
Denver Health
Denver, Colorado, 80204
Moses Cone
Greensboro, North Carolina, 27401
Baylor
Houston, Texas, 77030
Memorial Hermann Hospital - Texas Medical Center
Houston, Texas, 77030
University of Kentucky
Lexington, Kentucky, 40536
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Intermountain Medical Center
Murray, Utah, 84107
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Legacy Good Samaritan Medical Center
Portland, Oregon, 97210
Legacy Emanuel Medical Center
Portland, Oregon, 97227
Oregon Health Sciences University
Portland, Oregon, 97239
Rhode Island Hospital
Providence, Rhode Island, 02903
Regions Hospital
Saint Paul, Minnesota, 55101
University of Utah
Salt Lake City, Utah, 84108
South Texas Veterans Health Care System
San Antonio, Texas, 78229
University of Texas Health Science Center San Antonio
San Antonio, Texas, 78229
Baystate Medical Center
Springfield, Massachusetts, 01199
Scott & White Memorial Hospital
Temple, Texas, 76508
University of Arizona
Tucson, Arizona, 85724
About this study
Official title: Randomized Trial of Ticagrelor for Severe Community Acquired Pneumonia
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
- Being tested
- Ticagrelor, Placebo
- Keywords
- CAP, Pneumonia, Intensive Care Unit, Mechanical Ventilation
- Medical subject headings
- Community-Acquired Pneumonia, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicagrelorDrug
Also called Brilinta
Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days
PlaceboDrug
Placebo 180 mg loading dose followed by 90 mg BID for 90 days.
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor | Experimental | Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days Receives: Drug: Ticagrelor |
| Placebo | Placebo comparator | Placebo 180 mg loading dose followed by 90 mg BID for 90 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause Mortality
death during 90 day study period
Measured: 90 days
Secondary outcomes (7)
Shock Free Days
Not requiring pressor support for hypotension
Measured: 15 days
Ventilator Free Days
Measured: 29 days
In-hospital Mortality
Did the patient die during the hospitalization?
Measured: Throughout hospitalization (About 2 weeks)
Hospital Free Days
Number of days the patient is not in the hospital
Measured: 29 days
Stroke
Did the patient develop a stroke during the 90 day study?
Measured: 90 days
Stroke, Myocardial Infarct, Mortality
number of participants that suffered stroke, myocardial infarct, mortality
Measured: 90 days
Myocardial Infarction
Did the patient have a myocardial infarction during the 90 day study?
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startAug 2014
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: poor enrollment, unable to meet recruitment goals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Community Acquired Pneumonia, SevereStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gordon Bernard
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor-investigator, Gordon Bernard, Vanderbilt University Medical Center
- Investigators
- Gordon R Bernard, MD, Principal investigator, Vanderbilt University Medical CenterJon D Truwit, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01998399
- Sponsor's protocol ID
- 131908
- Acronym
- TCAP
- Status last verified
- Nov 2017
- First submitted
- 15 Nov 2013
- Last updated
- 11 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Ticagrelor for Severe Community Acquired Pneumonia
- ClinicalTrials.gov ID
- NCT01998399
- Acronym / sponsor ID
- TCAP / 131908
- Conditions
- Community Acquired Pneumonia, Severe
- Keywords
- CAP, Pneumonia, Intensive Care Unit, Mechanical Ventilation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor enrollment, unable to meet recruitment goals
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Gordon BernardUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Aug 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 28 Nov 2013 (estimated)
- Results
- Posted 11 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor | Experimental | Drug: TicagrelorTicagrelor 180 mg loading dose followed by 90 mg BID for 90 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 180 mg loading dose followed by 90 mg BID for 90 days. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Patients will have new "severe" CAP as defined by
- 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)
Key exclusion criteria (32 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TicagrelorAlso: BrilintaTicagrelor 180 mg loading dose followed by 90 mg BID for 90 days | Drug | Ticagrelor |
| PlaceboPlacebo 180 mg loading dose followed by 90 mg BID for 90 days. | Drug | Placebo |
Primary outcome
All-cause Mortality
Time frame: 90 days
death during 90 day study period
7 secondary outcomes
Shock Free Days
Time frame: 15 days
Ventilator Free Days
Time frame: 29 days
In-hospital Mortality
Time frame: Throughout hospitalization (About 2 weeks)
Hospital Free Days
Time frame: 29 days
Stroke
Time frame: 90 days
Stroke, Myocardial Infarct, Mortality
Time frame: 90 days
Myocardial Infarction
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gordon R Bernard, MD principal investigator
Vanderbilt University Medical Center
Jon D Truwit, MD principal investigator
Medical College of Wisconsin
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ticagrelor in people with Community Acquired Pneumonia, Severe, run by Gordon Bernard at 26 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause Mortality (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2017.