findmyKOL
Clinical trialNCT07332325Not, yet, recruitingPhase 3Interventional

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

SponsorUniversity of VirginiaEnrollment344SepsisTuberculosis
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

4 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Tanzania
  • Sekou Toure Regional Referral Hospital

    Mwanza, Tanzania

    Frederick C Mwita, MD
  • Kibong'Oto Infectious Diseases Hospital

    Sanya Juu, Tanzania

    Stellah G Mpagama, MD, PhD
Uganda
  • Fort Portal Regional Referral Hospital

    Fort Portal, Uganda

    Dalton K Munyambalu, MBChB, MMed
  • Mbarara Regional Referral Hospital

    Mbarara, Uganda

    Edwin Nuwagira, MBChB, MMed

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Expanded antimicrobial therapyHydrocortisone administration
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Oct 2026
Primary completion
31 Mar 2029
Completion
30 Sept 2029
Last update posted
1 Jun 2026
Registered enrollment
344
Registry id
NCT07332325

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.