NCT07332325Not yet recruitingPhase 3
STeroids and Enhanced Spectrum Antibiotics for the Treatment of Patients in Africa With Refractory Sepsis
STeroids and Enhanced Spectrum Antibiotics for the Treatment of Patients in Africa With Refractory Sepsis (STARS Trial)
Source: ClinicalTrials.gov · Last updated 1 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 344 (estimated)
- First submitted
- 6 Jan 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 31 Mar 2029
- Lead sponsor
- University of Virginia
- Diseases
- Tuberculosis
- NCT number
- NCT07332325
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 344
- From 1 Oct 2026 to the primary completion date, 31 Mar 2029
- 4 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known active TB or receiving anti-TB therapy
- Treatment with another investigational drug or other intervention within one month
- 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
Other illness
- Known allergic reactions to the components of the interventional therapy
- Known liver disease
Lab values
- Positive serum cryptococcal antigen test
Other
- 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.
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sekou Toure Regional Referral Hospital Coordinator of this site? Confirm its status | Mwanza | Tanzania | Unknown status |
| Kibong'oto Infectious Diseases Hospital Coordinator of this site? Confirm its status | Sanya Juu | Tanzania | Unknown status |
| Fort Portal Regional Referral Hospital Coordinator of this site? Confirm its status | Fort Portal | Uganda | Unknown status |
| Mbarara Regional Referral Hospital Coordinator of this site? Confirm its status | Mbarara | Uganda | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.