NIH-funded research U01 cooperative agreement

STeroids and enhanced Antibiotics for sepsis in Africa with HIV/TB (STARS)

Official title: STeroids and enhanced Antibiotics for the treatment of patients in Africa with Refractory Sepsis: STARS trial

Funded at University of Virginia · NIH-11617036 · Data updated 2026-11-12

This grant tests whether adding steroids and stronger antibiotics helps adults with severe sepsis tied to HIV/TB in areas with high TB rates.

More Sepsis research and trials

Quick facts

Grant typeU01 cooperative agreement
Study typeNIH-funded research
Funding institutionUniversity of Virginia
NIH-funded
Lab location1 site (Charlottesville, United States)
Project startSeptember 20, 2025
Project endAugust 31, 2030
Funding year2026
Award (this year)$162,000
NIH project number3U01AI192033-02S2
Project IDNIH-11617036 on NIH RePORTER

Who could benefit from this research

Could help

Adults (21+ years) with HIV/TB and sepsis admitted to participating hospitals in regions with high TB prevalence.

Less likely to help

Patients without sepsis or without HIV/TB–related immune suppression may not benefit.

What this research studies

Sepsis is a dangerous organ‑level illness caused by infection. This project focuses on adults with advanced immune suppression from HIV/TB who develop sepsis and may receive targeted steroid therapy plus intensified antibiotics. The study uses an observational foundation to guide a randomized approach, aiming to determine if a hydrocortisone treatment plan improves survival over standard care in the first month after hospital admission. It involves collaboration at sites with high TB burden and patients who meet specific clinical criteria.

Why it matters

Potential benefit: If successful, patients with sepsis and HIV/TB could have better chances of surviving initial critical illness.

How similar studies have gone: Observational data suggest corticosteroids may improve survival in some septic patients, but results have been mixed across trials.

Where this research is happening

  • University of Virginia
    Charlottesville, United States
    Active

Researchers

  • Principal investigator: Heysell, Scott K — University of Virginia
  • Study coordinator: Heysell, Scott K

Related research

Other NIH-funded projects on the same topics.

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.