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Tuberculosis / HIV I Infection / Sepsis-specific dose anti-TB therapy · Phase 3 Trial
ClinicalTrials.gov · September 9, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a completed Phase 3 factorial trial testing immediate empiric anti-TB therapy and optimized dosing versus standard care for sepsis in people living with HIV in Uganda and Tanzania. No results are reported in this registry record, so the efficacy or safety of the interventions cannot yet be evaluated.
Phase 3, Interventional, Randomized, Factorial, Single masking, Treatment purpose. Tuberculosis, HIV I Infection, Sepsis; age from 18 Years. Intervention: Immediate anti-TB therapy/conventional dose anti-TB therapy; Diagnosis dependent/sepsis specific dose anti-TB therapy; Immediate anti-TB therapy/sepsis specific dose anti-TB ther…. Compared with: Diagnosis dependent / conventional dose anti-TB therapy — No Intervention. n = 437. 2 sites: Tanzania, Uganda.
This is a completed Phase 3 factorial trial testing immediate empiric anti-TB therapy and optimized dosing versus standard care for sepsis in people living with HIV in Uganda and Tanzania. No results are reported in this registry record, so the efficacy or safety of the interventions cannot yet be evaluated.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
If results are practice-changing, this trial could alter the management of sepsis in sub-Saharan Africa by establishing whether early empiric anti-TB therapy and optimized dosing reduce 28-day mortality in this high-burden setting. Until published results are available, no clinical recommendations can be made.
Phase 3 RCT with completed recruitment (437 participants) addressing a significant clinical question, but this registry record reports no results; evidence strength cannot be assessed without outcome data.
As stated by the source record.
Quoted from the source exactly as published.
If results are practice-changing, this trial could alter the management of sepsis in sub-Saharan Africa by establishing whether early empiric anti-TB therapy and optimized dosing reduce 28-day mortality in this high-burden setting. Until published results are available, no clinical recommendations can be made.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT04618198). This is a study registration, not published results. Lead sponsor: University of Virginia. Recruitment status: COMPLETED. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 437 participants (ACTUAL). Conditions: Tuberculosis, HIV I Infection, Sepsis. Interventions: OTHER: Immediate anti-TB therapy; OTHER: Sepsis-specific dose anti-TB therapy. Primary outcome measures: 28-day Mortality , 28 days from enrollment. Brief summary: In sub-Saharan Africa, tuberculosis (TB) is the etiology of 25-50% of bloodstream infections (BSIs) and the leading cause of sepsis among people living with HIV. TB BSI is associated with 20-50% mortality, and 20-25% of deaths occur within five days of admission. TB BSI is difficult to identify clinically and microbiologically. Given that the high prevalence of TB BSI is under-recognized, most patients with sepsis in sub-Saharan Africa do not receive early anti-TB therapy. The hypothesis of this study is that immediate and optimally dosed anti-TB therapy will improve 28 day mortality in patients with sepsis in Uganda and Tanzania. Therefore, the overall goal is to conduct a phase 3 multi-site open label 2x2 factorial clinical trial of 1) empiric immediate initiation of anti-TB therapy plus standard care compared to diagnosis dependent anti-TB therapy plus standard care and 2) sepsis-specific dose anti-TB therapy plus standard care compared to conventional WHO weight-based dose anti-TB therapy plus standard care for the treatment of sepsis in people living with HIV admitted to our longstanding collaborative research sites at either the Mbarara Regional Referral Hospital in Mbarara, Uganda, or Kilimanjaro region hospitals in Moshi, Tanzania.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.