Steroid Treatment for Severe Acute Respiratory Infection (STAR) Trial
NCT07199192 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3000
Last updated 2026-02-19
Summary
Multicenter, parallel-group, randomized clinical trial comparing the administration of systemic corticosteroids at a dose equivalent to 40 mg of prednisolone per day for 7 days vs no corticosteroid administration among adults hospitalized with severe acute respiratory infection and hypoxemia.
Conditions
- Hypoxemia
- Severe Acute Respiratory Syndrome
Interventions
- DRUG
-
systemic corticosteroids at a dose equivalent to 40 mg of prednisolone per day for 7 days or until discharge
Sponsors & Collaborators
-
National Institutes of Health (NIH)
collaborator NIH - collaborator OTHER
-
National Institute of Allergy and Infectious Diseases (NIAID)
lead NIH
Principal Investigators
-
Matthew W Semler, MD · Vanderbilt University Medical Center
-
Jane O'Halloran, MD, PhD · Washington Univeristy School of Medicine (ID-CRU)
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-01
- Primary Completion
- 2028-12-01
- Completion
- 2028-12-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Study Evaluating the Impact of Using Triplex Rapid Diagnostic Tests (SARS-CoV-2/Influenza/RSV) on Antibiotic Prescribing
NCT07243249 ·Status: RECRUITING ·Phase: NA
-
Use of a Respiratory Multiplex PCR and Procalcitonin to Reduce Antibiotics Exposure in Patients With Severe Confirmed COVID-19 Pneumonia
NCT04334850 ·Status: COMPLETED ·Phase: NA
-
Use of MULTIplex PCR, Procalcitonin, and Sputum Appearance to Reduce Duration of Antibiotic Therapy During Severe COPD EXAcerbation: A Controlled, Randomized, Open-label, Parallel-Group, Multicenter Trial
NCT05280132 ·Status: RECRUITING ·Phase: NA
-
Corticosteroid Treatment for Community-Acquired Pneumonia - The STEP Trial
NCT00973154 ·Status: COMPLETED ·Phase: PHASE3
-
Corticosteroids for COVID-19
NCT04795583 ·Status: WITHDRAWN ·Phase: PHASE3
-
Individualizing Corticosteroid Use in Pneumonia
NCT05334316 ·Status: RECRUITING ·Phase: PHASE2
-
FebriDx DISRUPT Acute Respiratory Infection Trial in Acute Respiratory Infection: An Evaluation of FebriDx® POC Test
NCT02018198 ·Status: COMPLETED
-
Evaluation of the Efficacy of High Doses of Methylprednisolone in SARS-CoV2 ( COVID-19) Pneumonia Patients
NCT04673162 ·Status: COMPLETED ·Phase: PHASE3
-
Adaptive RCT of Corticosteroids for Severe Adenovirus Pneumonia in Adults
NCT07152600 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
Early Treatment Strategy With High-dose Dexamethasone in Patients With SARS-CoV-2
NCT05293210 ·Status: UNKNOWN ·Phase: PHASE3
-
Steroid and Anticoagulant Therapy in covid19
NCT05021588 ·Status: COMPLETED ·Phase: NA
-
Clinical Trial to Evaluate Methylprednisolone Pulses and Tacrolimus in Patients With COVID-19 Lung Injury
NCT04341038 ·Status: UNKNOWN ·Phase: PHASE3
-
Viral Testing and Biomarkers to Reduce Antibiotic Use for Respiratory Infections
NCT01907659 ·Status: COMPLETED ·Phase: NA
-
Oral Prednisone Regimens to Optimize the Therapeutic Strategy in Patients With Organizing Pneumonia Post-COVID-19
NCT04534478 ·Status: UNKNOWN ·Phase: PHASE4
-
Ruxolitinib for the Treatment of Acute Respiratory Distress Syndrome in Patients With COVID-19 Infection
NCT04361903 ·Status: UNKNOWN
-
Comparative Antibiotic Therapy for Subjects With Pulmonary Infiltrates in the ICU
NCT00307099 ·Status: TERMINATED ·Phase: PHASE3
-
Comparison Between Prednisolone and Dexamethasone on Mortality in Patients on Oxygen Therapy, with CoViD-19
NCT04765371 ·Status: COMPLETED ·Phase: PHASE3
-
Assess a Diagnostic Tool to Distinguish Between Bacterial and Viral Infection
NCT01931254 ·Status: COMPLETED
-
The Natural History of Hospitalized COVID-19 Patients
NCT04424992 ·Status: RECRUITING
-
An Adjunct Test Distinguishing Bacterial From Viral Etiology Improves Resource Utilization and Efficiency in the ED.
NCT06070688 ·Status: RECRUITING ·Phase: NA
-
Extended Steroid in Use in Community Acquired Pneumonia (CAP)(e)
NCT01283009 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Corticosteroids in Oxygen-dependent Patients With COVID-19 Pneumonia
NCT04359511 ·Status: WITHDRAWN ·Phase: PHASE3
-
Early Use of Corticosteroids in Non-critical Patients With COVID-19 Pneumonia
NCT04451174 ·Status: TERMINATED ·Phase: PHASE3
-
Procalcitonin Guided Antibiotic Use in Acute Respiratory Tract Infections (PARTI)-Study
NCT00099840 ·Status: COMPLETED ·Phase: NA
-
A Study in Patients With COVID-19 and Respiratory Distress Not Requiring Mechanical Ventilation, to Compare Standard-of-care With Anakinra and Tocilizumab Treatment The Immunomodulation-CoV Assessment (ImmCoVA) Study
NCT04412291 ·Status: UNKNOWN ·Phase: PHASE2