Individualizing Corticosteroid Use in Pneumonia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In this study, researchers propose a unique (individualized) approach to steroid treatment seeking to give the right dose of steroid to the right patient and at the right time. This study seeks to compare usual care to an individualized steroid dosing strategy by testing a marker of inflammation in the blood called C- reactive protein (CRP). The overall goal is to reduce an individual's exposure to steroids and the risk of potential side effects thereby increasing the potential benefit of using steroids to control inflammation in pneumonia.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prophylactic Corticosteroid to Prevent COVID-19 Cytokine Storm

NCT04355247

Covid-19

UNKNOWN PHASE2

Corticosteroid Therapy for Severe Community-Acquired Pneumonia

NCT02552342

Community Acquired Pneumonia

UNKNOWN PHASE4

Clinical Outcome of Patients With COVID-19 Pneumonia Treated With Corticosteroids and Colchicine

NCT04654416

Covid-19

COMPLETED

Early Short Course Corticosteroids in COVID-19

NCT04374071

COVID Pneumonia, Viral

COMPLETED

Extended Steroid in Use in Community Acquired Pneumonia (CAP)(e)

NCT01283009

Community Acquired Respiratory Disease Syndrome

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pneumonia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Usual Care Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Individualized dosing strategy

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 Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Administered intravenously or orally based on daily CRP values and CRP corticosteroid dosing algorithm

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dexamethasone

Administered intravenously or orally based on daily CRP values and CRP corticosteroid dosing algorithm

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Hospitalized adult (≥ 18 years) patients.
* Community acquired pneumonia.

Exclusion Criteria

* Contraindications or unwillingness to use corticosteroids by patient or provider.
* History of adrenal insufficiency, septic shock, or another absolute indication for steroid use.
* Suspected pulmonary vasculitis or other autoimmune pulmonary disorder.
* Positive pregnancy test
* Comfort care.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No