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STARS Trial: Hydrocortisone and Enhanced Antibiotics for Sepsis in HIV Patients
NCT07332325Phase 3
Key facts
- Status
- Not yet recruiting
- Start
- Oct 2026
- Primary completion
- Mar 2029
- Countries
- 2
- Sponsor
- University of Virginia
- Modality
- Small Molecules
- Conditions
- sepsis
01
Overview
Phase 3, randomised trial of hydrocortisone, rifampicin, isoniazid, levofloxacin and linezolid in sepsis (4 arms), sponsored by University of Virginia. Primary endpoint: Mortality at 28 days. Planned start Oct 2026; status: not yet recruiting.
02
Design
4 arms- Study design
- Randomized
No hydrocortisone/immediate anti-TB therapy
Standard of care including ceftriaxone alone.
Hydrocortisone/immediate anti-TB therapy
Hydrocortisone + Standard of care.
No hydrocortisone/enhanced spectrum antimicrobial therapy
Enhanced antimicrobial regimen (rifampin, isoniazid, linezolid, levofloxacin) + Standard of care.
Hydrocortisone/enhanced spectrum antimicrobial therapy
Hydrocortisone + Enhanced antimicrobial regimen + Standard of care.
03
Who it enrols
Adults living with HIV admitted to the hospital with sepsis (>=2 qSOFA criteria) and clinical concern for infection, excluding those with known active TB, pregnancy, liver disease, or heavy alcohol use.
04
Endpoints
Primary
Mortality
Secondary
In-hospital mortality
6-month mortality
Time to death
Incidence of new post-admission shock
Duration of hospitalization
Volume of IV fluids received
Adverse drug events during the 28-day study period
Time to ambulation
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