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Corticosteroid
Dexamethasone for Pneumonia
Phase 2
Waitlist Available
Led By Yewande Odeyemi, MBBS
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Community acquired pneumonia
Hospitalized adult (≥ 18 years) patients
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first 5 days of hospitalization or until hospital discharge (whichever is sooner)
Awards & highlights
Study Summary
This trial is testing a new way to give steroids to patients with pneumonia, which may be better than the usual care.
Who is the study for?
This trial is for adults hospitalized with community-acquired pneumonia. It's not suitable for those with adrenal insufficiency, septic shock, or conditions requiring steroids; pregnant women; and patients unwilling to use corticosteroids or on comfort care.Check my eligibility
What is being tested?
The study tests an individualized dosing strategy of Dexamethasone based on CRP levels in the blood against usual care. The aim is to optimize steroid use by giving the right amount at the best time to reduce side effects and improve outcomes.See study design
What are the potential side effects?
Potential side effects from Dexamethasone may include increased blood sugar levels, mood swings, increased risk of infection, bone density loss, indigestion, and sleep problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have pneumonia that I caught outside of a hospital.
Select...
I am an adult patient currently in the hospital.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ first 5 days of hospitalization or until hospital discharge (whichever is sooner)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first 5 days of hospitalization or until hospital discharge (whichever is sooner)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence to individual treatment rule and CRP-guided corticosteroid treatment
Secondary outcome measures
Advanced respiratory support free days
ICU and hospital free days
In-hospital Disease Progression
+2 moreSide effects data
From 2013 Phase 4 trial • 122 Patients • NCT014749152%
Deep Vein Thrombosis
2%
Cerebrospinal fluid leak
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Individualized dosing strategyExperimental Treatment1 Intervention
Biomarker guided corticosteroid use. Initiation of corticosteroid will be recommended based on the an individual treatment rule (ITR) and subsequent dosing of corticosteroid will be recommended based on daily CRP values till CRP <50 mg/L.
Group II: Usual Care GroupActive Control1 Intervention
Usual care as determined by the patient's primary team. Initiation and daily dosing of corticosteroid treatment will be based on clinicians' preference and clinicians.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,767,059 Total Patients Enrolled
7 Trials studying Pneumonia
1,674 Patients Enrolled for Pneumonia
Yewande Odeyemi, MBBSPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have pneumonia that I caught outside of a hospital.I might have lung inflammation caused by an autoimmune condition.You are pregnant according to a pregnancy test.I have a condition that requires me to use steroids.I cannot or do not want to use corticosteroids.I am an adult patient currently in the hospital.I am receiving care focused on my comfort.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care Group
- Group 2: Individualized dosing strategy
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment available for the current clinical trial?
"As indicated on clinicaltrials.gov, this particular medical trial is not accepting new participants at the moment; it was initially posted on July 1st 2023 and its most recent update occurred on April 12th 2022. Fortunately, there are 168 other trials presently enrolling patients for their research."
Answered by AI
What side effects might be associated with Dexamethasone use?
"Our team has assigned Dexamethasone a score of 2 due to the fact that, as this is Phase 2 trial, there are indications pointing towards its safety but none in regards to efficacy."
Answered by AI
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