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

Starting soon · Phase 3

Conditions studied: Sepsis, Tuberculosis

In brief

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 facts

Study ID

NCT07332325

Run by

University of Virginia

People needed

344

Starts

2026-10-01

Expected to finish

2029-09-01

Last updated by the study team

2026-06-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female aged ≥18 years living with HIV
• Admitted to hospital with 1) clinical concern for infection; 2) ≥2 qSOFA score criteria (Glasgow Coma Scale score <15, a respiratory rate ≥22, or a systolic blood pressure ≤90 mmHg or a mean arterial pressure of ≤65 mmHg)
• Resident within a pre-defined geographic area to ensure TB clinic follow-up
• For females of reproductive potential: use of highly effective contraception through 28 days

You may not qualify if…

• Known active TB or receiving anti-TB therapy
• Pregnancy or lactation. Women will undergo urine pregnancy screening. Pregnant people will be excluded due to lack of pharmacokinetic data for the expanded antibiotic regimen in pregnancy.
• Known allergic reactions to the components of the interventional therapy
• Treatment with another investigational drug or other intervention within one month
• Known liver disease
• Alcohol use > 14 standardized drinks per week and/or > 4 drinks per day for men and >7 standardized drinks per week and/or >3 drinks per day for women, defined as 14 grams of ethanol, as found in example 5 ounces of wine, 12 ounces of beer, or 1.5 ounces of 80 proof spirits
• Positive serum cryptococcal antigen test
• Current treatment with a drug known to have significant, non-correctable interaction with anti-TB therapy
• Already receiving corticosteroids at the time of presentation to the hospital

Where it is running

• 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

Full record on ClinicalTrials.gov

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