Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07332325
PHASE3

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

Sponsor: University of Virginia

View on ClinicalTrials.gov

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

Interventions

DRUG

Hydrocortisone administration

Immediate hydrocortisone at 200 mg IV daily for 7 days and a tapering schedule for an additional 7 days

DRUG

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