STeroids and Enhanced Spectrum Antibiotics for the Treatment of Patients in Africa With Refractory Sepsis

Sponsor
University of Virginia
Study ID
NCT07332325
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Sepsis
  • Tuberculosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hydrocortisone administration — DRUG
    Immediate hydrocortisone at 200 mg IV daily for 7 days and a tapering schedule for an additional 7 days
  • Expanded antimicrobial therapy — DRUG
    empiric initiation of the enhanced spectrum antimicrobial therapy regimen (rifampin, isoniazid, linezolid, and levofloxacin) for 14 days plus standard care which includes ceftriaxone for 7 days or diagnosis dependent conventional anti-TB therapy

Study Details

Sepsis, a life-threatening condition due to a dysregulated response to infection, is the leading cause of global mortality and is frequently driven by tuberculosis (TB) and drug-resistant bacteria in sub-Saharan Africa, particularly among people living with HIV. The prevailing standard of care in the region, ceftriaxone alone, is insufficient as it does not address TB, drug-resistant bacteria, or adrenal insufficiency, which is common in HIV-related sepsis. Therefore, the investigators propose a randomized 2x2 factorial clinical trial to compare 28-day survival from sepsis between study participants who along with a standard of care that includes immediate conventional anti-TB treatment receive 1) hydrocortisone to treat septic shock and 2) rifampin, isoniazid, levofloxacin and linezolid to treat TB and other drug-resistant bacteria in order to deliver important and scalable knowledge that may alter the standard of care for sepsis in HIV endemic settings of sub-Saharan Africa. Improving understanding of the physiology and treatment alternatives for HIV related critical illness globally will have reciprocal benefit for health in the U.S.

Key Dates

First listed
Jan 12, 2026
Start date
Oct 31, 2026
Status verified
May 2026
Primary completion
Mar 31, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
344 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • No Intervention: No hydrocortisone/immediate anti-TB therapy
    Standard of care
  • Experimental: Hydrocortisone/immediate anti-TB therapy
  • Experimental: No hydrocortisone/enhanced spectrum antimicrobial therapy
  • Experimental: Hydrocortisone/enhanced spectrum antimicrobial therapy

Primary Outcome Measure

Mortality [ Time Frame: 28 days from date of randomization ]

Central Contacts

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