Opportunistic Infections, HIV RelatedNCT07585461
Enhanced Treatment Strategy for Disseminated MAC Infection in HIV Patients: A Randomized Controlled Trial
A study testing Standard Triple Therapy and Experimental: Standard Triple Therapy Plus Fluoroquinolone in people with Opportunistic Infections, HIV Related and Disseminated Mycobacterium Avium Complex Infection, run by Shanghai Public Health Clinical Center.
Trial summary
Background: Disseminated Mycobacterium avium complex (MAC) infection remains a serious opportunistic infection in patients with advanced HIV infection, particularly among those with severe immunosuppression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opportunistic Infections, HIV Related, Disseminated Mycobacterium Avium Complex Infection
- What is being tested?
- Standard Triple Therapy and Experimental: Standard Triple Therapy Plus Fluoroquinolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2026to 31 Dec 2028
- Phase
- Interventional
- 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
- Age ≥18 years
- HIV infection confirmed
- Disseminated Mycobacterium avium complex (MAC) infection confirmed by positive culture from a sterile site or positive molecular/sequencing-based detection from a sterile site specimen considered clinically significant
- Systemic manifestations consistent with disseminated infection
- Planned initiation of standard antimycobacterial therapy
- Able and willing to provide written informed consent
Who cannot join
- Prior effective antimycobacterial treatment for >14 days before enrollment
- Known macrolide resistance, if susceptibility data are available
- Hypersensitivity to macrolides, ethambutol, rifamycins, or fluoroquinolones
- Baseline QTc >500 ms or history of significant cardiac arrhythmia
- Uncorrected hypokalemia or hypomagnesemia
- History of severe adverse reaction to fluoroquinolones, such as tendon rupture or severe neuropathy
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- Severe hepatic impairment or severe renal dysfunction precluding study treatment
- Concomitant medications that significantly prolong QT interval and cannot be safely discontinued
- Pregnancy or breastfeeding
- Coexisting infection requiring non-protocol antimycobacterial therapy, such as active tuberculosis
- Any condition that, in the investigator's judgment, would interfere with study participation or interpretation of results
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized, Controlled Trial Evaluating the Efficacy and Safety of Adding Fluoroquinolone (Levofloxacin or Moxifloxacin) to Standard Triple Therapy in Disseminated Mycobacterium Avium Complex Infection
Background:
Disseminated Mycobacterium avium complex (MAC) infection remains a serious opportunistic infection in patients with advanced HIV infection, particularly among those with severe immunosuppression. Despite the widespread use of antiretroviral therapy (ART), disseminated MAC (DMAC) continues to be associated with significant morbidity and mortality. The current standard treatment consists of a macrolide-based triple regimen, including a macrolide, ethambutol, and rifamycin. However, in patients with high mycobacterial burden or profound immunodeficiency, early microbiological response and clinical improvement are often suboptimal, and treatment is complicated by drug interactions and tolerability issues.
Read more
Objective:
This study aims to evaluate whether adding a fluoroquinolone (levofloxacin or moxifloxacin) to the standard triple therapy improves early clinical outcomes in HIV-infected patients with disseminated MAC infection.
Methods:
This is a prospective, multicenter, randomized, open-label, controlled trial. A total of 124 adult HIV-infected patients with confirmed disseminated MAC infection will be randomly assigned in a 1:1 ratio to receive either standard triple therapy (macrolide, ethambutol, and rifamycin) or an intensified four-drug regimen with the addition of a fluoroquinolone during the initial 8-week intensive phase. Participants will be followed for at least 24 weeks.
Outcomes:
The primary endpoint is the clinical symptom resolution rate at Day 28. Secondary endpoints include microbiological outcomes (culture or molecular conversion at Days 28, 56, and 84), time to culture conversion, mortality, relapse, and safety outcomes including adverse events and QT interval prolongation.
Significance:
This study will provide prospective evidence on whether an intensified treatment strategy can improve early clinical response and microbiological clearance in disseminated MAC infection, while maintaining an acceptable safety profile. The findings may help optimize treatment strategies for HIV-associated disseminated MAC infection.
Read the detailed description
Background and Rationale:
Disseminated Mycobacterium avium complex (MAC) infection remains a major opportunistic infection in patients with advanced HIV infection, particularly among those with severe immunosuppression (e.g., CD4 <50 cells/μL). Although the incidence of disseminated MAC (DMAC) has declined in the era of antiretroviral therapy (ART), it continues to pose a substantial clinical burden due to delayed diagnosis, high mycobacterial load, and frequent co-infections. Clinically, DMAC often presents with systemic symptoms such as fever, weight loss, anemia, and multi-organ involvement, including bone marrow, liver, spleen, and lymph nodes.
Current guidelines recommend a macrolide-based triple therapy consisting of a macrolide (azithromycin or clarithromycin), ethambutol, and a rifamycin (typically rifabutin). This regimen has demonstrated efficacy in reducing mortality and preventing macrolide resistance. However, in real-world clinical practice, early microbiological clearance and symptom improvement remain suboptimal, particularly in patients with high disease burden or delayed immune reconstitution. In addition, drug-drug interactions, especially with ART, and tolerability issues may limit treatment effectiveness.
Fluoroquinolones have demonstrated in vitro activity against mycobacteria and possess favorable pharmacokinetic properties, including good tissue penetration. Retrospective studies suggest that the addition of a fluoroquinolone to standard regimens may improve outcomes in disseminated MAC infection, but high-quality prospective evidence is lacking. Therefore, an intensified treatment strategy incorporating a fluoroquinolone during the early phase of therapy may enhance bacterial clearance and improve clinical outcomes.
Study Objectives:
The primary objective of this study is to determine whether adding a fluoroquinolone (levofloxacin or moxifloxacin) to standard triple therapy improves clinical symptom resolution at Day 28 in HIV-infected patients with disseminated MAC infection.
Secondary objectives include evaluating microbiological outcomes (culture or molecular conversion), time to culture conversion, mortality, relapse, treatment failure, and safety outcomes, including adverse events and QT interval prolongation.
Study Design:
This is a prospective, multicenter, randomized, open-label, controlled clinical trial. A total of 124 eligible adult participants with confirmed disseminated MAC infection will be enrolled and randomized in a 1:1 ratio to one of two treatment arms.
Control group: Standard triple therapy consisting of a macrolide (azithromycin or clarithromycin), ethambutol, and rifabutin (or an equivalent rifamycin-based regimen according to local practice).
Experimental group: Standard triple therapy plus a fluoroquinolone (levofloxacin or moxifloxacin), administered during the initial 8-week intensive phase.
The choice of fluoroquinolone will be determined at baseline based on clinical considerations such as renal function and risk of QT interval prolongation, and will remain fixed during the intensive phase unless safety concerns necessitate modification.
Treatment and Follow-up:
Participants will receive study treatment according to group assignment, with ART initiated or continued as per standard clinical practice, typically within 2 weeks after starting anti-MAC therapy. Patients will be followed for at least 24 weeks, with scheduled visits at baseline and predefined time points (e.g., Days 7, 14, 28, 56, and 84, and Weeks 24 and beyond).
Clinical assessments will include symptom evaluation, physical examination, laboratory tests, and safety monitoring. Microbiological assessments will include culture and/or molecular testing from blood or other sterile sites, with emphasis on consistent sampling sources across time points.
Outcome Measures:
The primary endpoint is the proportion of participants achieving clinical symptom resolution at Day 28, defined by sustained defervescence, improvement in symptom scores, stabilization or gain in body weight, absence of treatment escalation, and survival.
Secondary endpoints include:
Microbiological conversion rates at Days 28, 56, and 84 Time to culture conversion All-cause and MAC-related mortality Relapse and treatment failure rates Safety outcomes, including adverse events (graded by CTCAE), serious adverse events, and QT interval changes
Safety Considerations:
Fluoroquinolones are associated with potential adverse effects, including QT interval prolongation, tendon disorders, and central nervous system toxicity. Therefore, baseline and periodic electrocardiogram monitoring will be performed, along with electrolyte assessment and careful evaluation of concomitant medications. Predefined criteria for dose adjustment or discontinuation will be applied to ensure participant safety.
Significance:
This study aims to generate high-quality prospective evidence on whether an intensified four-drug regimen can improve early clinical and microbiological outcomes in disseminated MAC infection without compromising safety. The results may inform future treatment guidelines and optimize management strategies for HIV-associated disseminated MAC infection.
- Being tested
- Standard Triple Therapy, Experimental: Standard Triple Therapy Plus Fluoroquinolone
- Keywords
- Disseminated MAC, HIV, Fluoroquinolone
- Medical subject headings
- AIDS-Related Opportunistic Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Triple TherapyDrug
Also called Azithromycin, Clarithromycin, Ethambutol, Rifabutin
Standard triple therapy for disseminated MAC infection consisting of a macrolide, ethambutol, and rifabutin, administered according to protocol-defined dosing and duration.
Experimental: Standard Triple Therapy Plus FluoroquinoloneDrug
Also called Azithromycin, Ethambutol, Rifabutin, Levofloxacin
Participants receive standard therapy for disseminated Mycobacterium avium complex infection plus a fluoroquinolone during the initial 8-week intensive phase.
| Study group | Role | What they receive |
|---|---|---|
| Standard Triple Therapy | Active comparator | Participants receive standard triple therapy for disseminated Mycobacterium avium complex infection, consisting of a macrolide (azithromycin or clarithromycin), ethambutol, and rifabutin. Antiretroviral therapy is continued or initiated according to standard clinical practice and drug-drug interaction assessment. Receives: Drug: Standard Triple Therapy |
| Standard Triple Therapy Plus Fluoroquinolone | Experimental | Participants receive standard triple therapy for disseminated Mycobacterium avium complex infection, consisting of a macrolide (azithromycin or clarithromycin), ethambutol, and rifabutin, plus a fluoroquinolone (levofloxacin or moxifloxacin) during the initial 8-week intensive phase. The fluoroquinolone is selected at baseline based on clinical considerations and is intended to remain unchanged during the intensive phase unless modification is required for safety reasons. Antiretroviral therapy is continued or initiated according to standard clinical practice and drug-drug interaction assessment. Receives: Drug: Experimental: Standard Triple Therapy Plus Fluoroquinolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Symptom Resolution Rate at Day 28
The proportion of participants achieving clinical symptom resolution at Day 28. Clinical symptom resolution is defined as meeting all of the following criteria:
- absence of fever for at least 48 hours without the use of antipyretics;
- improvement in systemic symptoms, defined as a ≥50% reduction in total symptom score or all individual symptom scores ≤1;
- stabilization or increase in body weight compared with baseline;
- no requirement for escalation or modification of antimycobacterial therapy due to disease progression;
- survival through Day 28. Participants who do not meet all criteria, require rescue therapy, or die before Day 28 are classified as non-responders.
Measured: Day 28 (±3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start30 Apr 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opportunistic Infections, HIV RelatedStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Public Health Clinical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Li Liu, Shanghai Public Health Clinical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07585461
- Sponsor's protocol ID
- DMAC-RCT-2026
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices), will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled Trial Evaluating the Efficacy and Safety of Adding Fluoroquinolone (Levofloxacin or Moxifloxacin) to Standard Triple Therapy in Disseminated Mycobacterium Avium Complex Infection
- ClinicalTrials.gov ID
- NCT07585461
- Acronym / sponsor ID
- DMAC-RCT-2026
- Keywords
- Disseminated MAC, HIV, Fluoroquinolone
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Shanghai Public Health Clinical CenterOther government
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 13 May 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.
Background:
Disseminated Mycobacterium avium complex (MAC) infection remains a serious opportunistic infection in patients with advanced HIV infection, particularly among those with severe immunosuppression. Despite the widespread use of antiretroviral therapy (ART), disseminated MAC (DMAC) continues to be associated with significant morbidity and mortality. The current standard treatment consists of a macrolide-based triple regimen, including a macrolide, ethambutol, and rifamycin. However, in patients with high mycobacterial burden or profound immunodeficiency, early microbiological response and clinical improvement are often suboptimal, and treatment is complicated by drug interactions and tolerability issues.
Objective:
This study aims to evaluate whether adding a fluoroquinolone (levofloxacin or moxifloxacin) to the standard triple therapy improves early clinical outcomes in HIV-infected patients with disseminated MAC infection.
Methods:
This is a prospective, multicenter, randomized, open-label, controlled trial. A total of 124 adult HIV-infected patients with confirmed disseminated MAC infection will be randomly assigned in a 1:1 ratio to receive either standard triple therapy (macrolide, ethambutol, and rifamycin) or an intensified four-drug regimen with the addition of a fluoroquinolone during the initial 8-week intensive phase. Participants will be followed for at least 24 weeks.
Outcomes:
The primary endpoint is the clinical symptom resolution rate at Day 28. Secondary endpoints include microbiological outcomes (culture or molecular conversion at Days 28, 56, and 84), time to culture conversion, mortality, relapse, and safety outcomes including adverse events and QT interval prolongation.
Significance:
This study will provide prospective evidence on whether an intensified treatment strategy can improve early clinical response and microbiological clearance in disseminated MAC infection, while maintaining an acceptable safety profile. The findings may help optimize treatment strategies for HIV-associated disseminated MAC infection.
Detailed description
Background and Rationale:
Disseminated Mycobacterium avium complex (MAC) infection remains a major opportunistic infection in patients with advanced HIV infection, particularly among those with severe immunosuppression (e.g., CD4 <50 cells/μL). Although the incidence of disseminated MAC (DMAC) has declined in the era of antiretroviral therapy (ART), it continues to pose a substantial clinical burden due to delayed diagnosis, high mycobacterial load, and frequent co-infections. Clinically, DMAC often presents with systemic symptoms such as fever, weight loss, anemia, and multi-organ involvement, including bone marrow, liver, spleen, and lymph nodes.
Current guidelines recommend a macrolide-based triple therapy consisting of a macrolide (azithromycin or clarithromycin), ethambutol, and a rifamycin (typically rifabutin). This regimen has demonstrated efficacy in reducing mortality and preventing macrolide resistance. However, in real-world clinical practice, early microbiological clearance and symptom improvement remain suboptimal, particularly in patients with high disease burden or delayed immune reconstitution. In addition, drug-drug interactions, especially with ART, and tolerability issues may limit treatment effectiveness.
Fluoroquinolones have demonstrated in vitro activity against mycobacteria and possess favorable pharmacokinetic properties, including good tissue penetration. Retrospective studies suggest that the addition of a fluoroquinolone to standard regimens may improve outcomes in disseminated MAC infection, but high-quality prospective evidence is lacking. Therefore, an intensified treatment strategy incorporating a fluoroquinolone during the early phase of therapy may enhance bacterial clearance and improve clinical outcomes.
Study Objectives:
The primary objective of this study is to determine whether adding a fluoroquinolone (levofloxacin or moxifloxacin) to standard triple therapy improves clinical symptom resolution at Day 28 in HIV-infected patients with disseminated MAC infection.
Secondary objectives include evaluating microbiological outcomes (culture or molecular conversion), time to culture conversion, mortality, relapse, treatment failure, and safety outcomes, including adverse events and QT interval prolongation.
Study Design:
This is a prospective, multicenter, randomized, open-label, controlled clinical trial. A total of 124 eligible adult participants with confirmed disseminated MAC infection will be enrolled and randomized in a 1:1 ratio to one of two treatment arms.
Control group: Standard triple therapy consisting of a macrolide (azithromycin or clarithromycin), ethambutol, and rifabutin (or an equivalent rifamycin-based regimen according to local practice).
Experimental group: Standard triple therapy plus a fluoroquinolone (levofloxacin or moxifloxacin), administered during the initial 8-week intensive phase.
The choice of fluoroquinolone will be determined at baseline based on clinical considerations such as renal function and risk of QT interval prolongation, and will remain fixed during the intensive phase unless safety concerns necessitate modification.
Treatment and Follow-up:
Participants will receive study treatment according to group assignment, with ART initiated or continued as per standard clinical practice, typically within 2 weeks after starting anti-MAC therapy. Patients will be followed for at least 24 weeks, with scheduled visits at baseline and predefined time points (e.g., Days 7, 14, 28, 56, and 84, and Weeks 24 and beyond).
Clinical assessments will include symptom evaluation, physical examination, laboratory tests, and safety monitoring. Microbiological assessments will include culture and/or molecular testing from blood or other sterile sites, with emphasis on consistent sampling sources across time points.
Outcome Measures:
The primary endpoint is the proportion of participants achieving clinical symptom resolution at Day 28, defined by sustained defervescence, improvement in symptom scores, stabilization or gain in body weight, absence of treatment escalation, and survival.
Secondary endpoints include:
Microbiological conversion rates at Days 28, 56, and 84 Time to culture conversion All-cause and MAC-related mortality Relapse and treatment failure rates Safety outcomes, including adverse events (graded by CTCAE), serious adverse events, and QT interval changes
Safety Considerations:
Fluoroquinolones are associated with potential adverse effects, including QT interval prolongation, tendon disorders, and central nervous system toxicity. Therefore, baseline and periodic electrocardiogram monitoring will be performed, along with electrolyte assessment and careful evaluation of concomitant medications. Predefined criteria for dose adjustment or discontinuation will be applied to ensure participant safety.
Significance:
This study aims to generate high-quality prospective evidence on whether an intensified four-drug regimen can improve early clinical and microbiological outcomes in disseminated MAC infection without compromising safety. The results may inform future treatment guidelines and optimize management strategies for HIV-associated disseminated MAC infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Triple Therapy | Active comparator | Drug: Standard Triple TherapyParticipants receive standard triple therapy for disseminated Mycobacterium avium complex infection, consisting of a macrolide (azithromycin or clarithromycin), ethambutol, and rifabutin. Antiretroviral therapy is continued or initiated according to standard clinical practice and drug-drug interaction assessment. |
| Standard Triple Therapy Plus Fluoroquinolone | Experimental | Drug: Experimental: Standard Triple Therapy Plus FluoroquinoloneParticipants receive standard triple therapy for disseminated Mycobacterium avium complex infection, consisting of a macrolide (azithromycin or clarithromycin), ethambutol, and rifabutin, plus a fluoroquinolone (levofloxacin or moxifloxacin) during the initial 8-week intensive phase. The fluoroquinolone is selected at baseline based on clinical considerations and is intended to remain unchanged during the intensive phase unless modification is required for safety reasons. Antiretroviral therapy is continued or initiated according to standard clinical practice and drug-drug interaction assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years
- HIV infection confirmed
- Disseminated Mycobacterium avium complex (MAC) infection confirmed by positive culture from a sterile site or positive molecular/sequencing-based detection from a sterile site specimen considered clinically significant
- Systemic manifestations consistent with disseminated infection
- Planned initiation of standard antimycobacterial therapy
Key exclusion criteria (11 listed)
- Prior effective antimycobacterial treatment for >14 days before enrollment
- Known macrolide resistance, if susceptibility data are available
- Hypersensitivity to macrolides, ethambutol, rifamycins, or fluoroquinolones
- Baseline QTc >500 ms or history of significant cardiac arrhythmia
- Uncorrected hypokalemia or hypomagnesemia
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 |
|---|---|---|
| Standard Triple TherapyAlso: Azithromycin, Clarithromycin, Ethambutol, RifabutinStandard triple therapy for disseminated MAC infection consisting of a macrolide, ethambutol, and rifabutin, administered according to protocol-defined dosing and duration. | Drug | Standard Triple Therapy |
| Experimental: Standard Triple Therapy Plus FluoroquinoloneAlso: Azithromycin, Ethambutol, Rifabutin, LevofloxacinParticipants receive standard therapy for disseminated Mycobacterium avium complex infection plus a fluoroquinolone during the initial 8-week intensive phase. | Drug | Standard Triple Therapy Plus Fluoroquinolone |
Primary outcome
Clinical Symptom Resolution Rate at Day 28
Time frame: Day 28 (±3 days)
The proportion of participants achieving clinical symptom resolution at Day 28. Clinical symptom resolution is defined as meeting all of the following criteria: 1. absence of fever for at least 48 hours without the use of antipyretics; 2. improvement in systemic symptoms, defined as a ≥50% reduction in total symptom score or all individual symptom scores ≤1; 3. stabilization or increase in body weight compared with baseline; 4. no requirement for escalation or modification of antimycobacterial therapy due to disease progression; 5. survival through Day 28. Participants who do not meet all criteria, require rescue therapy, or die before Day 28 are classified as non-responders.
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 13 May 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices), will be shared.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Triple Therapy and Experimental: Standard Triple Therapy Plus Fluoroquinolone in people with Opportunistic Infections, HIV Related and Disseminated Mycobacterium Avium Complex Infection, run by Shanghai Public Health Clinical Center.
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 11 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 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Li LIU, M.D. (8618916091026, liuli@shaphc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Symptom Resolution Rate at Day 28 (time frame: Day 28 (±3 days)). 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 13 May 2026.