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STeroids and Enhanced Spectrum Antibiotics for the Treatment of Patients in Africa With Refractory Sepsis
Sponsor: University of Virginia
Summary
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 current standard of care in the region, ceftriaxone, 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 the standard of care 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.
Official title: STeroids and Enhanced Spectrum Antibiotics for the Treatment of Patients in Africa With Refractory Sepsis (STARS Trial)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
344
Start Date
2026-04
Completion Date
2029-09
Last Updated
2026-01-12
Healthy Volunteers
No
Conditions
Interventions
Hydrocortisone administration
Immediate hydrocortisone at 200 mg IV daily for 7 days and a tapering schedule for an additional 7 days
Expanded antimicrobial therapy
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
Locations (4)
Sekou Toure Regional Referral Hospital
Mwanza, Tanzania
Kibong'oto Infectious Diseases Hospital
Sanya Juu, Tanzania
Fort Portal Regional Referral Hospital
Fort Portal, Uganda
Mbarara Regional Referral Hospital
Mbarara, Uganda