SepsisPhase 3STARSNCT07332325
STeroids and Enhanced Spectrum Antibiotics for the Treatment of Patients in Africa With Refractory Sepsis
A Phase 3 study testing Hydrocortisone administration and Expanded antimicrobial therapy in people with Sepsis and Tuberculosis, run by University of Virginia at 4 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Tuberculosis
- What is being tested?
- Hydrocortisone administration and Expanded antimicrobial therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 344 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Oct 2026to Sep 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
Tanzania2 sites
Sekou Toure Regional Referral Hospital
Mwanza
Frederick C Mwita, MD, +255282502171, Cyprianfredy@gmail.com
Frederick C Mwita, MD
Kibong'oto Infectious Diseases Hospital
Sanya Juu
Stellah G Kibong'oto, MD, PhD, +255272974140, sempagama@yahoo.com
Bibie Said, MD, +255272974140, bibiesd90@gmail.com
Uganda2 sites
Fort Portal Regional Referral Hospital
Fort Portal
Dalton K Munyambalu, MBChB, MMed, +256 717 555139, daltonkamuda@gmail.com
Dalton K Munyambalu, MBChB, MMed
Mbarara Regional Referral Hospital
Mbarara
Edwin Nuwagira, MBChB, MMed, +256485420030, enuwagira@must.ac.ug
Edwin Nuwagira, MBChB, MMed
About this study
Official title: STeroids and Enhanced Spectrum Antibiotics for the Treatment of Patients in Africa With Refractory Sepsis (STARS Trial)
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.
Read the detailed description
Sepsis is defined as life-threatening organ dysfunction due to a dysregulated host response to infection and is the leading cause of global mortality. The World Health Organization has declared sepsis a global priority. Yet, little is known about sepsis in the global South and specifically sub-Saharan Africa where there are an estimated 17 million cases and 3.5 million attributable deaths per year. The majority of these patients are living with human immunodeficiency virus (HIV). The investigators have determined the leading cause of sepsis in this region is tuberculosis (TB) which is responsible for 25-30% of bloodstream infections in septic patients. TB sepsis is associated with 20-50% mortality rates with the majority of deaths occurring within the first 4-5 days of admission. Other causative pathogens include bacteria commonly or intrinsically resistant to third-generation cephalosporins which are the standard antimicrobial treatment for sepsis adopted from the global North. The investigators have also studied anti-TB pharmacokinetics/pharmacodynamics in septic patients and discovered considerably low circulating drug concentrations that are suboptimal for microbial kill. Concurrently, the investigators have also found a high burden of corticosteroid insufficiency in people with critical illness at collaborative study sites in Uganda and Tanzania. HIV and TB, independently and in combination, contribute to adrenal infection and endogenous steroid insufficiency. In further observational study, adults with sepsis at the collaborative study sites treated with corticosteroids have significantly improved survival from septic shock in-line with some, but not all, trials of adjunctive steroids in infection associated critical illness. Therefore, hypotheses are that immediate hydrocortisone administered over 7 days followed by a 7-day taper will improve 28 day mortality compared to the standard of care where corticosteroids are not administered, and that an enhanced antimicrobial regimen for 14 days to target TB and other drug-resistant bacteria of sepsis (rifampin, isoniazid, levofloxacin and linezolid) will improve 28 day mortality compared to the standard of care of immediate conventional anti-TB treatment and ceftriaxone alone. These hypotheses will be tested through a randomized 2x2 factorial clinical trial where participants hospitalized with HIV and sepsis will be randomized to 1) hydrocortisone or the standard care without hydrocortisone, and 2) the enhanced antimicrobial regimen plus ceftriaxone or the standard care with ceftriaxone alone. This randomized 2x2 factorial clinical trial is strongly endorsed by Tanzanian and Ugandan stakeholders, utilizes drugs that are available within national formularies and regional pharmacies, and if successful will be scalable for adults with sepsis in HIV endemic regions of sub-Saharan Africa. Improved understanding of the physiology and treatment alternatives for HIV related critical illness globally will have reciprocal benefit for health in the U.S.
- Conditions
- Sepsis, Tuberculosis
- Being tested
- Hydrocortisone administration, Expanded antimicrobial therapy
- Keywords
- Sepsis, HIV, tuberculosis, Africa
- Medical subject headings
- Sepsis, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrocortisone administrationDrug
Immediate hydrocortisone at 200 mg IV daily for 7 days and a tapering schedule for an additional 7 days
Expanded antimicrobial therapyDrug
empiric initiation of the enhanced spectrum antimicrobial therapy regimen (rifampin, isoniazid, linezolid, and levofloxacin) for 14 days plus standard care which includes ceftriaxone for 7 days or diagnosis dependent conventional anti-TB therapy
| Study group | Role | What they receive |
|---|---|---|
| No hydrocortisone/immediate anti-TB therapy | No intervention | Standard of care |
| Hydrocortisone/immediate anti-TB therapy | Experimental | Not described Receives: Drug: Hydrocortisone administration |
| No hydrocortisone/enhanced spectrum antimicrobial therapy | Experimental | Not described Receives: Drug: Expanded antimicrobial therapy |
| Hydrocortisone/enhanced spectrum antimicrobial therapy | Experimental | Not described Receives: Drug: Hydrocortisone administration; Drug: Expanded antimicrobial therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Primary outcome measure
Measured: 28 days from date of randomization
Secondary outcomes (16)
In-hospital mortality
Mortality
Measured: from enrollment through hospitalization, an average of 14 days
6-month mortality
Mortality
Measured: From the date of randomization until death or 180 days from randomization
Time to death
Mortality
Measured: From date of randomization to death or 180 days from randomization
Incidence of new post-admission shock
New post-admission shock
Measured: From the time of enrollment through hospital discharge, an average of 14 days
Duration of hospitalization
Duration of hospitalization
Measured: From the time of randomization until date of hospital discharge up to 180 days, or death if before hospital discharge
Volume of IV fluids received
Volume of IV fluids received
Measured: From the date of randomization until date of hospital discharge up to 180 days, or date of death if occurring before discharge
Adverse drug events during the 28-day study period
Adverse drug events
Measured: From date of randomization to 28 days post randomization or date of death if death occurred before 28 days
Time to ambulation
Time to ambulation
Measured: From date of randomization until the date of first documented ambulation during hospitalization, or date of death from any cause, whichever came first, on average over 14 days, but up to 180 days
Time to temperature normalization
Time to temperature normalization
Measured: From date of randomization until the date of first documented normal temperature during hospitalization, or date of death from any cause, whichever came first, on average over 14 days, but up to 180 days
Lactate/delta lactate
Lactate concentration change
Measured: From the date of randomization until the date of hospital discharge or the date of death if death occurred before discharge, on average 14 days
Capillary fill time/delta capillary fill time
Change in capillary fill time
Measured: From the date of randomization until the date of hospital discharge or the date of death if death occurred before discharge, on average 14 days
Universal Vital Assessment score and delta Universal Vital Assessment score: component number one, heart rate
Calculation of initial Universal Vital Assessment mortality risk score at randomization and 72 hours after randomization: component number one, measure heart rate
Measured: From the time of randomization to 72 hours after randomization
Universal Vital Assessment mortality risk score at randomization and 72 hours after randomization: component number two, respiratory rate
Calculation of initial Universal Vital Assessment mortality risk score at randomization and 72 hours after randomization: component number two, measure respiratory rate
Measured: From time to randomization to 72 hours
Calculation of initial Universal Vital Assessment mortality risk score at randomization and 72 hours after randomization: component number three, systolic blood pressure
Calculation of initial Universal Vital Assessment mortality risk score at randomization and 72 hours after randomization: component number three, measure systolic blood pressure
Measured: From time to randomization to 72 hours
Calculation of initial Universal Vital Assessment mortality risk score at randomization and 72 hours after randomization: component number four, oxygen saturation
Calculation of initial Universal Vital Assessment mortality risk score at randomization and 72 hours after randomization: component number four, measure oxygen saturation
Measured: From time to randomization to 72 hours
Calculation of initial Universal Vital Assessment mortality risk score at randomization and 72 hours after randomization: component number five, glascow coma scale
Calculation of initial Universal Vital Assessment mortality risk score at randomization and 72 hours after randomization: component number five, record record level of consciousness by glascow come scale
Measured: From time to randomization to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study startOct 2026 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 344 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Heysell, MD, University of Virginia
- Investigators
- Scott K Heysell, MD, MPH, Principal investigator, University of VirginiaChristopher C Moore, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07332325
- Sponsor's protocol ID
- HSR302304
- Other IDs
- 1U01AI192033-01
- Acronym
- STARS
- Status last verified
- May 2026
- First submitted
- 6 Jan 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STeroids and Enhanced Spectrum Antibiotics for the Treatment of Patients in Africa With Refractory Sepsis (STARS Trial)
- ClinicalTrials.gov ID
- NCT07332325
- Acronym / sponsor ID
- STARS / HSR302304
- Conditions
- Sepsis, Tuberculosis
- Keywords
- Sepsis, HIV, tuberculosis, Africa
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 344 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Sepsis is defined as life-threatening organ dysfunction due to a dysregulated host response to infection and is the leading cause of global mortality. The World Health Organization has declared sepsis a global priority. Yet, little is known about sepsis in the global South and specifically sub-Saharan Africa where there are an estimated 17 million cases and 3.5 million attributable deaths per year. The majority of these patients are living with human immunodeficiency virus (HIV). The investigators have determined the leading cause of sepsis in this region is tuberculosis (TB) which is responsible for 25-30% of bloodstream infections in septic patients. TB sepsis is associated with 20-50% mortality rates with the majority of deaths occurring within the first 4-5 days of admission. Other causative pathogens include bacteria commonly or intrinsically resistant to third-generation cephalosporins which are the standard antimicrobial treatment for sepsis adopted from the global North. The investigators have also studied anti-TB pharmacokinetics/pharmacodynamics in septic patients and discovered considerably low circulating drug concentrations that are suboptimal for microbial kill. Concurrently, the investigators have also found a high burden of corticosteroid insufficiency in people with critical illness at collaborative study sites in Uganda and Tanzania. HIV and TB, independently and in combination, contribute to adrenal infection and endogenous steroid insufficiency. In further observational study, adults with sepsis at the collaborative study sites treated with corticosteroids have significantly improved survival from septic shock in-line with some, but not all, trials of adjunctive steroids in infection associated critical illness. Therefore, hypotheses are that immediate hydrocortisone administered over 7 days followed by a 7-day taper will improve 28 day mortality compared to the standard of care where corticosteroids are not administered, and that an enhanced antimicrobial regimen for 14 days to target TB and other drug-resistant bacteria of sepsis (rifampin, isoniazid, levofloxacin and linezolid) will improve 28 day mortality compared to the standard of care of immediate conventional anti-TB treatment and ceftriaxone alone. These hypotheses will be tested through a randomized 2x2 factorial clinical trial where participants hospitalized with HIV and sepsis will be randomized to 1) hydrocortisone or the standard care without hydrocortisone, and 2) the enhanced antimicrobial regimen plus ceftriaxone or the standard care with ceftriaxone alone. This randomized 2x2 factorial clinical trial is strongly endorsed by Tanzanian and Ugandan stakeholders, utilizes drugs that are available within national formularies and regional pharmacies, and if successful will be scalable for adults with sepsis in HIV endemic regions of sub-Saharan Africa. Improved understanding of the physiology and treatment alternatives for HIV related critical illness globally will have reciprocal benefit for health in the U.S.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No hydrocortisone/immediate anti-TB therapy | No intervention | –Standard of care |
| Hydrocortisone/immediate anti-TB therapy | Experimental | Drug: Hydrocortisone administration |
| No hydrocortisone/enhanced spectrum antimicrobial therapy | Experimental | Drug: Expanded antimicrobial therapy |
| Hydrocortisone/enhanced spectrum antimicrobial therapy | Experimental | Drug: Hydrocortisone administration, Drug: Expanded antimicrobial therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrocortisone administrationImmediate hydrocortisone at 200 mg IV daily for 7 days and a tapering schedule for an additional 7 days | Drug | Hydrocortisone/enhanced spectrum antimicrobial therapy, Hydrocortisone/immediate anti-TB therapy |
| Expanded antimicrobial therapyempiric initiation of the enhanced spectrum antimicrobial therapy regimen (rifampin, isoniazid, linezolid, and levofloxacin) for 14 days plus standard care which includes ceftriaxone for 7 days or diagnosis dependent conventional anti-TB therapy | Drug | Hydrocortisone/enhanced spectrum antimicrobial therapy, No hydrocortisone/enhanced spectrum antimicrobial therapy |
Primary outcome
Mortality
Time frame: 28 days from date of randomization
Primary outcome measure
16 secondary outcomes
In-hospital mortality
Time frame: from enrollment through hospitalization, an average of 14 days
6-month mortality
Time frame: From the date of randomization until death or 180 days from randomization
Time to death
Time frame: From date of randomization to death or 180 days from randomization
Incidence of new post-admission shock
Time frame: From the time of enrollment through hospital discharge, an average of 14 days
Duration of hospitalization
Time frame: From the time of randomization until date of hospital discharge up to 180 days, or death if before hospital discharge
Volume of IV fluids received
Time frame: From the date of randomization until date of hospital discharge up to 180 days, or date of death if occurring before discharge
Adverse drug events during the 28-day study period
Time frame: From date of randomization to 28 days post randomization or date of death if death occurred before 28 days
Time to ambulation
Time frame: From date of randomization until the date of first documented ambulation during hospitalization, or date of death from any cause, whichever came first, on average over 14 days, but up to 180 days
Time to temperature normalization
Time frame: From date of randomization until the date of first documented normal temperature during hospitalization, or date of death from any cause, whichever came first, on average over 14 days, but up to 180 days
Lactate/delta lactate
Time frame: From the date of randomization until the date of hospital discharge or the date of death if death occurred before discharge, on average 14 days
Capillary fill time/delta capillary fill time
Time frame: From the date of randomization until the date of hospital discharge or the date of death if death occurred before discharge, on average 14 days
Universal Vital Assessment score and delta Universal Vital Assessment score: component number one, heart rate
Time frame: From the time of randomization to 72 hours after randomization
Universal Vital Assessment mortality risk score at randomization and 72 hours after randomization: component number two, respiratory rate
Time frame: From time to randomization to 72 hours
Calculation of initial Universal Vital Assessment mortality risk score at randomization and 72 hours after randomization: component number three, systolic blood pressure
Time frame: From time to randomization to 72 hours
Calculation of initial Universal Vital Assessment mortality risk score at randomization and 72 hours after randomization: component number four, oxygen saturation
Time frame: From time to randomization to 72 hours
Calculation of initial Universal Vital Assessment mortality risk score at randomization and 72 hours after randomization: component number five, glascow coma scale
Time frame: From time to randomization to 72 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Scott K Heysell, MD, MPH principal investigator
University of Virginia
Christopher C Moore, MD principal investigator
University of Virginia
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydrocortisone administration and Expanded antimicrobial therapy in people with Sepsis and Tuberculosis, run by University of Virginia at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Tanzania, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Scott K Heysell, MD, MPH (434-924-0000 ext. 6962, SKH8R@uvahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 28 days from date of randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.