Community-acquired PneumoniaPhase 2NCT04652414
Corticosteroids in Community Acquired Pneumonia
A Phase 2 study testing Prednisone in people with Community-acquired Pneumonia and Cognition Disorder, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
This is a single-center, blinded, placebo-controlled pilot RCT evaluating corticosteroids for the treatment of Community Acquired Pneumonia (CAP) that will enroll 100 adults hospitalized with community-acquired pneumonia. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Community-acquired Pneumonia, Cognition Disorder
- What is being tested?
- Prednisone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 30 Jul 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Age ≥ 50 years
- Hospital admission to ward or ICU (including observation status admissions)
- Acute pneumonia defined as fulfilling each of the following two criteria: (a) New (<7-day duration) or worsening symptoms consistent with a lower respiratory tract infection, including ≥ 1 of the following: cough, shortness of breath, chest pain, sputum production, or decline in mental status; (b) Radiographic findings on chest x-ray or CT consistent with acute pulmonary infection, including pulmonary opacities, infiltrates, or pleural effusion.
- CRP ≥ 15 mg/dL within 24 hours of enrollment
Who cannot join
- Systemic steroid use within the past 30-days.
- Clinical team planning to treat with systemic steroids during this hospitalization independent of the study protocol.
- Unable to randomize patient within 24 hours of hospital presentation.
- Hospital-acquired pneumonia, defined as development of clinical and radiographic signs of pneumonia as an inpatient in an acute care hospital. (Residence in a nursing home or assisted living facility is not an exclusion criterion.)
- Unable to follow simple commands or non-verbal prior to this acute illness.
- Pre-existing severe dementia, defined as an Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) score ≥ 4.12.
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- Concomitant acute decompensated heart failure requiring intravenous diuretics
- Serum sodium > 145 mEq/L (hypernatremia) or potassium < 3.5 mEq/L (hypokalemia) at screening and randomization
- Systolic blood pressure > 180 mmHg or a diastolic blood pressure > 100 mmHg at the start and end of screening.
- Any history of diabetes mellitus, having a serum blood glucose > 250 mg/dL, or requiring an anti-diabetic medication (e.g., insulin)
- Previous allergic or adverse reaction to a corticosteroid
- Severe immunosuppression, defined as any of the following: HIV with CD4 count < 200 cells/mm3, absolute neutrophil count < 500 cells/mm3, solid organ or hematopoietic stem cell transplant with in the past 90 days.
- Cystic fibrosis
- Active cancer, defined as new diagnosis or treatment for cancer in the past 6 months.
- Any history of adrenal insufficiency
- Substance abuse (alcohol, opioid, benzodiazepines, methamphetamines, cocaine) within the past year
- Any history of hospitalizations due to psychiatric illnesses within the past year
- Gastro-intestinal bleeding treated with hospital admission and/or blood transfusion within the past 3 months.
- Pre-existing medical condition resulting in a life expectancy < 6 months.
- Clinical team does not believe the patient should enter the study due to concerns about potential steroid-related complications.
- Alternative non-pneumonia illness accounts for the acute clinical or radiographic findings that meet the study's inclusion criteria.
- Unable to take the enteral study medicine by mouth or tube
- Prior enrollment in this study at any time
- Non-English speaking
- Confirmed or suspected COVID-19 as the cause of the patient's acute illness -
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Corticosteroid Treatment for Community-Acquired Pneumonia to Improve Long-term Cognition: A Pilot Randomized Controlled Trial
This is a single-center, blinded, placebo-controlled pilot RCT evaluating corticosteroids for the treatment of Community Acquired Pneumonia (CAP) that will enroll 100 adults hospitalized with community-acquired pneumonia. The primary goal is to assess the feasibility of proposed trial procedures for use in a subsequent phase III trial powered on 6-month cognitive outcome (MOCA-Blind score). Key outcomes are six-month cognitive and functional status, duration and severity of symptoms, and mortality.
- Conditions
- Community-acquired Pneumonia, Cognition Disorder
- Being tested
- Prednisone, Placebo
- Medical subject headings
- Community-Acquired Pneumonia, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
Prednisone 50mg will be administered enterally for 7 days.
PlaceboDrug
This is a matching placebo to prednisone.
| Study group | Role | What they receive |
|---|---|---|
| Prednisone | Experimental | Patients randomized to the intervention arm will receive prednisone 50mg PO daily for 7 days. Receives: Drug: Prednisone |
| Placebo | Placebo comparator | Patients will receive matching placebo PO daily for 7 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as determined by the number of subjects who are successfully recruited and complete follow-up
Feasibility will be defined as: (a) recruitment and successful protocol completion of 100 patients; (b) corticosteroids being well tolerated, as shown by similar severity and frequency of adverse events in the intervention and placebo groups; (c) successful completion of 6-month cognitive assessments by >80% of survivors; and (d) the primary cognitive outcome Montreal Cognitive Assessment-Blind (MOCA-Blind) numerically favoring the intervention group with the one-tailed upper 80% confidence interval of the difference in MOCA-Blind between the intervention and placebo groups containing the minimally-important clinical difference (2 points on the MOCA-Blind).
Measured: 1.5 years
Secondary outcomes (15)
Global cognition as measured by the Montreal Cognitive Assessment-Blind (MOCA-Blind)
This is a measure of global cognition based on the assessment of attention concentration, memory, language, conceptual thinking, calculations, and orientation. Scores range from 0 to 22 with higher scores indicating better cognition.
Measured: 6-months
Severity of pneumonia symptoms as measured by the Community-Acquired Pneumonia Symptom (CAP-Sym) Questionnaire
This is a 18-item scale to determine the presence and severity of pneumonia symptoms. Each item is graded on a 6-point Likert scale. Scores range from 0 to 90 with higher scores indicating more severe symptoms.
Measured: 3-days
Severity of pneumonia symptoms as measured by the Community-Acquired Pneumonia Symptom (CAP-Sym) Questionnaire
This is a 18-item scale to determine the presence and severity of pneumonia symptoms. Each item is graded on a 6-point Likert scale. Scores range from 0 to 90 with higher scores indicating more severe symptoms.
Measured: 7-days
Severity of pneumonia symptoms as measured by the Community-Acquired Pneumonia Symptom (CAP-Sym) Questionnaire
This is a 18-item scale to determine the presence and severity of pneumonia symptoms. Each item is graded on a 6-point Likert scale. Scores range from 0 to 90 with higher scores indicating more severe symptoms.
Measured: 30-days
Quality of life as measured by the EQ-5D-5L
Characterizes quality of life and contains 5-dimensions ("5D") related to everyday living: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It asks patients to rate their current global health status from 0 (worst health you can imagine) to 100 (best health you can imagine). Scores range from -0.573 to 1.000 with higher scores indicating better quality of life.
Measured: 6-months
Basic activities of daily living (ADL) as measured by the Barthel's Index
Quantifies pre-illness basic ADLs such as bathing, dressing, toileting, transferring, continence, and feeding. Scores range from 0 to 20 with higher scores indicating better functioning.
Measured: 6-months
Instrumental ADL as measured by Lawton Instrumental Activities of Daily Living Scale (IADLs)
Quantifies pre-illness IADLs - ability to use the phone, shopping, food preparation, housekeeping, laundry, transportation, medication management, and finances. Scores range from 0 to 8 with higher scores indicating better functioning.
Measured: 6-months
Employment status as characterized by the Outcomes After Critical Illness and Surgery (OACIS) Employment Status Questionnaire
9-item survey that characterizes the patient's baseline (prior to the critical illness) and current level of employment (full, partial, or not employed). Patients will be categorized as loss of employment or no loss of employment.
Measured: 6-months
Vital status (dead / alive)
Death during the index hospitalization will be recorded.
Measured: Baseline to hospital discharge, approximately 5 days
Vital status (dead / alive)
Death within 6-months will be recorded.
Measured: 6-months
Intensive care unit admission (yes/no)
Intensive care unit admission at any point during the index hospitalization will be recorded.
Measured: Baseline to hospital discharge, approximately 5 days
Mechanical ventilation (yes/no)
Invasive mechanical ventilation is defined as new assisted positive pressure breathing through an endotracheal tube or tracheostomy for any duration. Noninvasive ventilation through a mask or nasal prongs does not satisfy the outcome of invasive mechanical ventilation.
Measured: Baseline to hospital discharge, approximately 5 days
Vasopressor use (yes/no)
defined as the administration of any of the following medications by continuous infusion for at least 1 hour during the index hospitalization: norepinephrine, epinephrine, dopamine, phenylephrine or vasopressin.
Measured: Baseline to hospital discharge, approximately 5 days
Pleural drainage (yes/no)
Pleural drainage is defined as removal of fluid from the pleural space by any procedure at the bedside or in the operating room during the index hospitalization; procedures such as thoracentesis and video-assisted thorascopic surgery (VATS) may be used to drain pleural fluid.
Measured: Baseline to hospital discharge, approximately 5 days
Hospital length of stay in (days)
Duration of hospitalization (presentation to hospital discharge) will be recorded.
Measured: Baseline to hospital discharge, approximately 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start1 Dec 2020
- Primary completion30 Jul 2022
- Study completion30 Jul 2022
Why it stopped: Limited enrollment due to the COVID-19 pandemic. Sponsor withdrew funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin H. Han, Vanderbilt University Medical Center
- Investigators
- Jin Han, MD,MSc, Principal investigator, Vanderbilt University Medical CenterWesley Self, MD, MPH, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652414
- Sponsor's protocol ID
- 200278
- Status last verified
- Feb 2023
- First submitted
- 24 Nov 2020
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corticosteroid Treatment for Community-Acquired Pneumonia to Improve Long-term Cognition: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04652414
- Acronym / sponsor ID
- 200278
- Conditions
- Community-acquired Pneumonia, Cognition Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Limited enrollment due to the COVID-19 pandemic. Sponsor withdrew funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 3 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, blinded, placebo-controlled pilot RCT evaluating corticosteroids for the treatment of Community Acquired Pneumonia (CAP) that will enroll 100 adults hospitalized with community-acquired pneumonia. The primary goal is to assess the feasibility of proposed trial procedures for use in a subsequent phase III trial powered on 6-month cognitive outcome (MOCA-Blind score). Key outcomes are six-month cognitive and functional status, duration and severity of symptoms, and mortality.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisone | Experimental | Drug: PrednisonePatients randomized to the intervention arm will receive prednisone 50mg PO daily for 7 days. |
| Placebo | Placebo comparator | Drug: PlaceboPatients will receive matching placebo PO daily for 7 days. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 50 years
- Hospital admission to ward or ICU (including observation status admissions)
- Acute pneumonia defined as fulfilling each of the following two criteria: (a) New (<7-day duration) or worsening symptoms consistent with a lower respiratory tract infection, including ≥ 1 of the following: cough, shortness of breath, chest pain, sputum production, or decline in mental status; (b) Radiographic findings on chest x-ray or CT consistent with acute pulmonary infection, including pulmonary opacities, infiltrates, or pleural effusion.
- CRP ≥ 15 mg/dL within 24 hours of enrollment
Key exclusion criteria (25 listed)
- Systemic steroid use within the past 30-days.
- Clinical team planning to treat with systemic steroids during this hospitalization independent of the study protocol.
- Unable to randomize patient within 24 hours of hospital presentation.
- Hospital-acquired pneumonia, defined as development of clinical and radiographic signs of pneumonia as an inpatient in an acute care hospital. (Residence in a nursing home or assisted living facility is not an exclusion criterion.)
- Unable to follow simple commands or non-verbal prior to this acute illness.
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 |
|---|---|---|
| PrednisonePrednisone 50mg will be administered enterally for 7 days. | Drug | Prednisone |
| PlaceboThis is a matching placebo to prednisone. | Drug | Placebo |
Primary outcome
Feasibility as determined by the number of subjects who are successfully recruited and complete follow-up
Time frame: 1.5 years
Feasibility will be defined as: (a) recruitment and successful protocol completion of 100 patients; (b) corticosteroids being well tolerated, as shown by similar severity and frequency of adverse events in the intervention and placebo groups; (c) successful completion of 6-month cognitive assessments by >80% of survivors; and (d) the primary cognitive outcome Montreal Cognitive Assessment-Blind (MOCA-Blind) numerically favoring the intervention group with the one-tailed upper 80% confidence interval of the difference in MOCA-Blind between the intervention and placebo groups containing the minimally-important clinical difference (2 points on the MOCA-Blind).
15 secondary outcomes
Global cognition as measured by the Montreal Cognitive Assessment-Blind (MOCA-Blind)
Time frame: 6-months
Severity of pneumonia symptoms as measured by the Community-Acquired Pneumonia Symptom (CAP-Sym) Questionnaire
Time frame: 3-days
Severity of pneumonia symptoms as measured by the Community-Acquired Pneumonia Symptom (CAP-Sym) Questionnaire
Time frame: 7-days
Severity of pneumonia symptoms as measured by the Community-Acquired Pneumonia Symptom (CAP-Sym) Questionnaire
Time frame: 30-days
Quality of life as measured by the EQ-5D-5L
Time frame: 6-months
Basic activities of daily living (ADL) as measured by the Barthel's Index
Time frame: 6-months
Instrumental ADL as measured by Lawton Instrumental Activities of Daily Living Scale (IADLs)
Time frame: 6-months
Employment status as characterized by the Outcomes After Critical Illness and Surgery (OACIS) Employment Status Questionnaire
Time frame: 6-months
Vital status (dead / alive)
Time frame: Baseline to hospital discharge, approximately 5 days
Vital status (dead / alive)
Time frame: 6-months
Intensive care unit admission (yes/no)
Time frame: Baseline to hospital discharge, approximately 5 days
Mechanical ventilation (yes/no)
Time frame: Baseline to hospital discharge, approximately 5 days
Vasopressor use (yes/no)
Time frame: Baseline to hospital discharge, approximately 5 days
Pleural drainage (yes/no)
Time frame: Baseline to hospital discharge, approximately 5 days
Hospital length of stay in (days)
Time frame: Baseline to hospital discharge, approximately 5 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- 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.
Jin Han, MD,MSc principal investigator
Vanderbilt University Medical Center
Wesley Self, MD, MPH principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prednisone in people with Community-acquired Pneumonia and Cognition Disorder, run by Vanderbilt University Medical Center at 1 site 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 4 inclusion and 25 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: withdrawn, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Feasibility as determined by the number of subjects who are successfully recruited and complete follow-up (time frame: 1.5 years). 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 8 Feb 2023.