CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 44 enrolled
Drug / intervention
Methylprednisolone +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03852537
NCT03852537Phase 2Completed

SMART Trial: Steroid Dosing by bioMARker Guided Titration in Critically Ill Patients With Pneumonia

Mayo Clinic·interventional·Posted Feb 25, 2019·Updated Sep 16, 2021

In Brief

A Phase 2 clinical trial evaluating Methylprednisolone and Usual Care for Pneumonia. Completed, enrolled 44 participants across 1 site.

Detailed Summary

This research study is being done to determine the appropriate dose of steroids and the appropriate duration for steroid use to reduce inflammation in severe pneumonia needing a form of breathing support. This study seeks to compare usual care to a unique (individualized) dosing strategy. A marker of inflammation in the body will be measured in blood samples. This marker of inflammation is called C- reactive protein. The overall goal is to identify patients that will benefit most from steroid use and decrease use of steroids. The information collected from this study may provide information that may improve management of patients with severe pneumonia requiring a form of breathing support.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPneumonia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedFeb 25, 2019
Enrollment StartDec 2, 2019
Primary CompletionNov 17, 2020
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 7.4 years ago

Interventions

Methylprednisolonedrug

Methylprednisolone will be administered based on CRP-guided protocol outlined under 'Biomarker-adjusted steroid dosing'.

Usual Careother

Usual care as determined by the patients treatment team.