Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD)Phase 2NCT05496374
A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SPR720 as Compared With Placebo for the Treatment of Participants With Mycobacterium Avium Complex (MAC) Pulmonary Disease
A Phase 2 study testing SPR720 500 mg and SPR720 1000 mg in people with Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD), run by Spero Therapeutics at 28 sites in United States.
Trial summary
The purpose of the study is to evaluate 1. The microbiological response and clinical efficacy of SPR720 compared with placebo in participants with nontuberculous mycobacteria pulmonary disease (NTM-PD). 2. The safety and tolerability of SPR720 in participants with NTM- PD 3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD)
- What is being tested?
- SPR720 500 mg and SPR720 1000 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 28 sitesUnited States
- Study dates
- 14 Dec 2022to 2 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Has a prior diagnosis of NTM-PD due to MAC according to American Thoracic Society (ATS) criteria
- Has at least one prior lower respiratory culture (sputum or bronchoalveolar lavage [BAL]) positive for MAC in the 12 months prior to consent
- Has an induced sputum culture at Screening positive for MAC by quantitative culture on solid agar
- Is either treatment naïve and has not received any prior treatment for MAC, OR if previously treated for MAC and meets all of the following criteria:
- Has a history of successful treatment with sputum culture conversion to negative
- Has recent sputum or BAL culture evidence of recurrent or relapsed disease and
Show all 21Show fewer
- Has been off therapy for at least 3 months prior to consent
- Has clinical signs and symptoms within the 6 weeks prior to consent that are consistent with NTM-PD with ≥2 of the following:
- chronic cough
- fatigue
- frequent throat clearing
- shortness of breath (dyspnea)
- coughing up of blood (hemoptysis)
- excessive mucus (sputum) production
- fever (temperature >38ºC or >100.4ºF)
- night sweats
- loss of appetite
- unintended weight loss
- wheezing
- chest pain
- Has a measured forced expiratory volume in the first second following maximal inhalation (FEV1) % predicted ≥30% within 3 months prior to consent. If prior FEV1% predicted test result is not available, obtain FEV1% predicted at Screening to confirm eligibility
Who cannot join
- In the opinion of the Investigator, is not a candidate for a 5-month delay in initiation of standard multidrug therapy to participate in a placebo-controlled clinical trial (e.g., participant has severe symptoms or, extensive disease burden)
- Has disseminated or extrapulmonary NTM disease
- Has end-stage NTM-PD or treatment-refractory NTM-PD
- Has isolation on lower respiratory (sputum or BAL) cultures of any Mycobacterium species other than those included in MAC within the 6 months prior to consent
- Has any other condition or prior therapy, which, in the opinion of the Investigator, would make the participant unsuitable for this study, including compliance with all study assessments and adherence to the protocol schedule of assessment
- Prior exposure to SPR720. Participants who are unable to comply with the requirements of the study or who in the opinion of the Investigator should not participate in the study are not eligible
- Other inclusion and exclusion criteria as per protocol may apply.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Medical facility
Atlanta, Georgia, 30342
Medical Facility
Birmingham, Alabama, 35233
Medical Facility
Chapel Hill, North Carolina, 27599
Medical Facility
Charleston, South Carolina, 29425
Medical Facility
Cleveland, Ohio, 44106
Medical Facility
Denison, Texas, 75020
Medical Facility
Fresno, California, 93701
Medical Facility
Iowa City, Iowa, 52242
Medical Facility
Kansas City, Kansas, 66103
Medical Facility
Kissimmee, Florida, 34746-4654
Medical Facility
Lebanon, New Hampshire, 03756
Medical Facility
Los Angeles, California, 90033
Medical Facility
Loxahatchee Groves, Florida, 33470
Medical Facility
Miami, Florida, 33136
Medical Facility
New Bedford, Massachusetts, 02740
Medical Facility
New Hyde Park, New York, 11042
Medical Facility
Newport Beach, California, 92663
Medical Facility
Northridge, California, 91324
Medical Facility
Pittsburgh, Pennsylvania, 15213
Medical Facility
Portland, Oregon, 97239
Medical Facility
Rochester, Minnesota, 55905
Medical Facility
Santa Clarita, California, 91355
Medical Facility
Sebring, Florida, 33870
Medical Facility
Sherman, Texas, 75090
Medical Facility
Tampa, Florida, 33606
Medical Facility
Tyler, Texas, 75708
Medical Facility
Washington D.C., District of Columbia, 20007
Medical Facility
Winston-Salem, North Carolina, 27103
About this study
Official title: A Randomized, Investigator-Blinded, Placebo-Controlled, Multicenter, Phase 2, Dose-Ranging Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SPR720 as Compared With Placebo for the Treatment of Patients With Mycobacterium Avium Complex (MAC) Pulmonary Disease
The purpose of the study is to evaluate
- The microbiological response and clinical efficacy of SPR720 compared with placebo in participants with nontuberculous mycobacteria pulmonary disease (NTM-PD).
- The safety and tolerability of SPR720 in participants with NTM- PD
- The pharmacokinetic (PK) of SPR719, active moiety, following orally (po) administered prodrug SPR720 in participants with NTM-PD.
- Being tested
- Placebo, SPR720 500 mg, SPR720 1000 mg
- Keywords
- Mycobacterium avium Complex, MAC, Pulmonary disease
- Medical subject headings
- Mycobacterium avium-intracellulare Infection, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo-matching capsules was administered orally.
SPR720 500 mgDrug
SPR720 500 mg (250 mg × 2 capsules) was administered orally.
SPR720 1000 mgDrug
SPR720 500 mg (250 mg × 4 capsules) was administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Investigator Blind: Placebo | Placebo comparator | Participants received SPR720 matching-placebo capsules, orally, once daily (QD) for 56 days. Receives: Drug: Placebo |
| Investigator Blind: SPR720 500 mg | Experimental | Participants received SPR720 500 mg (250 mg × 2) capsules along with 2 SPR720 matching- placebo capsules, orally, QD for 56 days. Receives: Drug: SPR720 500 mg |
| Investigator Blind: SPR720 1000 mg | Experimental | Participants received SPR720 1000 mg (250 mg × 4) capsules, orally, QD for 56 days. Receives: Drug: SPR720 1000 mg |
| Open-label: SPR720 1000 mg | Experimental | Participants received SPR720 1000 mg (250 mg × 4) capsules, orally, QD for 56 days. Receives: Drug: SPR720 1000 mg |
| Open-label: SPR720 500 mg | Experimental | Participants received SPR720 500 mg (250 mg × 2) capsules, orally, twice daily (BID) for 56 days. Receives: Drug: SPR720 500 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Slope of the Weekly Sputum Log10 Colony Forming Units Per Millilitre (CFU/mL) Change From Day 1 Through 56 in micro-Intent to Treat (m-ITT) Population
Measured: Days 1 through 56 (end of the treatment [EOT])
Secondary outcomes (20)
Slope of the Weekly Sputum Log10 CFU/mL Change From Days 1 Through 28 in micro-ITT Population
Measured: Days 1 through 28
Slope of the Time to Positivity (TTP) using Mycobacteria Growth Indicator Tube (MGIT) on Samples of Induced Sputum From Days 1 Through 56 (EOT) in micro-ITT Population
Measured: Days 1 through 56 (EOT)
Change from Baseline in the Sputum Log10 CFU/mL in the micro-ITT Population
Measured: Days 1 through 56 (EOT)
Change from Baseline in the Sputum TTP Using MGIT in micro-ITT Population
Measured: Days 1 through 56 (EOT)
Time to Negative Sputum Culture in micro-ITT Population
Measured: Days 1 through 56 (EOT)
Percent with Negative Sputum Culture in micro-ITT Population
Measured: Days 14 through Day 84 (FU)
Changes in Susceptibility in SPR719 From Days 1 through 56 (EOT) in the micro-ITT Population
Susceptibility is ≥4-fold increase in minimum inhibitory concentration for same pathogen identified at Baseline.
Measured: Days 1 through 56 (EOT)
Clinical Response in the micro-ITT Population
Investigator indicated their assessment of participants overall clinical response as resolved, improved, unchanged, or worsened.
Measured: Baseline up to Day 84 (FU)
Clinical Response in the Clinically Evaluable (CE) Populations
Investigator indicated their assessment of participants overall clinical response as resolved, improved, unchanged, or worsened.
Measured: Baseline up to Day 84 (FU)
Change From Baseline in 11-point Nontuberculous Mycobacteria Pulmonary Disease (NTM-PD) Symptoms and Impact Scale for Quality of Life (QOL) Assessments
The 11-point NTM-PD Symptoms and Impact Scale will evaluate specific clinical signs and symptoms and QOL improvements and will include symptoms of chronic cough, fatigue, frequent throat clearing, dyspnea, hemoptysis, excessive mucus (sputum) production, chills, night sweats, loss of appetite, unintended weight loss, wheezing, and chest pain.
Measured: Baseline up to FU Day 84
Change From Baseline in 6-point Patient Global Impression of Severity (PGI-S) Scale for Quality of Life (QOL) Assessments
The PGI-S scale is comprised of a 6-point verbal descriptor scale to determine meaningful change reported for the other symptom ratings in participants with NTM-PD.
Measured: Baseline up to FU Day 84
Change From Baseline in 7-point Patient Global Impression of Change (PGI-C) scale for Quality of Life (QOL) Assessments
The PGI-C scale is a patient-reported rating of improvement on a 7-point verbal descriptor scale.
Measured: Baseline up to FU Day 84
Change From Baseline in Flu, COVID-19, or Other Illness Questionnaire (2 questions) for Quality of Life (QOL) Assessments
This 2-question form will assess the participants flu, COVID-19 or other illness status and how these illnesses have affected the participants NTM-PD disease over the past 7 days.
Measured: Baseline up to FU Day 84
Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS®) V1.0 Fatigue Short form 7a scale for Quality of Life (QOL) Assessments
The PROMIS® scale will assess the participants experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities using a validated 5-point Likert scale.
Measured: Baseline up to FU Day 84
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational/experimental) product, whether related to this product or not.
Measured: From first dose of study drug (Day 1) up to follow up Day 84
Maximum Plasma Concentration (Cmax) (Intensive PK group only)
Measured: Pre-dose and post-dose on Days 1 and 14
Time to reach Cmax (Tmax) (Intensive PK group only)
Measured: Pre-dose and post-dose on Days 1 and 14
Area Under the Concentration-time Curve (AUC0-τ) (Intensive PK group only)
Measured: Pre-dose and post-dose on Days 1 and 14
Accumulation Ratio of SPR719 Cmax on Day 14 Compared to Day 1 (Intensive PK group only)
Measured: Pre-dose and post-dose on Days 1 and 14
Accumulation Ratio of SPR719 AUC0-τ on Day 14 Compared to Day 1 (Intensive PK group only)
Measured: Pre-dose and post-dose on Days 1 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start14 Dec 2022
- Primary completion8 Oct 2024
- Study completion2 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spero Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xilla Ussrey, MD, Study director, Spero Therapeutics Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496374
- Sponsor's protocol ID
- SPR720-202
- Status last verified
- Oct 2025
- First submitted
- 9 Aug 2022
- Last updated
- 9 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ussery XT, Bhatt N, Critchley IA, Wong SL, Pottage JC Jr, Melnick D, Hamed KA. Randomized study of the efficacy, safety, and pharmacokinetics of SPR720 for the treatment of Mycobacterium avium complex pulmonary disease. Sci Rep. 2026 Feb 20;16(1):10063. doi: 10.1038/s41598-026-40505-7.
PubMed 41720869
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Investigator-Blinded, Placebo-Controlled, Multicenter, Phase 2, Dose-Ranging Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SPR720 as Compared With Placebo for the Treatment of Patients With Mycobacterium Avium Complex (MAC) Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05496374
- Acronym / sponsor ID
- SPR720-202
- Keywords
- Mycobacterium avium Complex, MAC, Pulmonary disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Spero TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 14 Dec 2022 (actual)
- Primary completion
- 8 Oct 2024 (actual)
- Study completion
- 2 Dec 2024 (actual)
- First posted
- 11 Aug 2022 (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.
The purpose of the study is to evaluate
- The microbiological response and clinical efficacy of SPR720 compared with placebo in participants with nontuberculous mycobacteria pulmonary disease (NTM-PD).
- The safety and tolerability of SPR720 in participants with NTM- PD
- The pharmacokinetic (PK) of SPR719, active moiety, following orally (po) administered prodrug SPR720 in participants with NTM-PD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Investigator Blind: Placebo | Placebo comparator | Drug: PlaceboParticipants received SPR720 matching-placebo capsules, orally, once daily (QD) for 56 days. |
| Investigator Blind: SPR720 500 mg | Experimental | Drug: SPR720 500 mgParticipants received SPR720 500 mg (250 mg × 2) capsules along with 2 SPR720 matching- placebo capsules, orally, QD for 56 days. |
| Investigator Blind: SPR720 1000 mg | Experimental | Drug: SPR720 1000 mgParticipants received SPR720 1000 mg (250 mg × 4) capsules, orally, QD for 56 days. |
| Open-label: SPR720 1000 mg | Experimental | Drug: SPR720 1000 mgParticipants received SPR720 1000 mg (250 mg × 4) capsules, orally, QD for 56 days. |
| Open-label: SPR720 500 mg | Experimental | Drug: SPR720 500 mgParticipants received SPR720 500 mg (250 mg × 2) capsules, orally, twice daily (BID) for 56 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Has a prior diagnosis of NTM-PD due to MAC according to American Thoracic Society (ATS) criteria
- Has at least one prior lower respiratory culture (sputum or bronchoalveolar lavage [BAL]) positive for MAC in the 12 months prior to consent
- Has an induced sputum culture at Screening positive for MAC by quantitative culture on solid agar
- Is either treatment naïve and has not received any prior treatment for MAC, OR if previously treated for MAC and meets all of the following criteria:
- Has clinical signs and symptoms within the 6 weeks prior to consent that are consistent with NTM-PD with ≥2 of the following:
Key exclusion criteria (7 listed)
- In the opinion of the Investigator, is not a candidate for a 5-month delay in initiation of standard multidrug therapy to participate in a placebo-controlled clinical trial (e.g., participant has severe symptoms or, extensive disease burden)
- Has disseminated or extrapulmonary NTM disease
- Has end-stage NTM-PD or treatment-refractory NTM-PD
- Has isolation on lower respiratory (sputum or BAL) cultures of any Mycobacterium species other than those included in MAC within the 6 months prior to consent
- Has any other condition or prior therapy, which, in the opinion of the Investigator, would make the participant unsuitable for this study, including compliance with all study assessments and adherence to the protocol schedule of assessment
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 |
|---|---|---|
| PlaceboPlacebo-matching capsules was administered orally. | Drug | Investigator Blind: Placebo |
| SPR720 500 mgSPR720 500 mg (250 mg × 2 capsules) was administered orally. | Drug | Investigator Blind: SPR720 500 mg, Open-label: SPR720 500 mg |
| SPR720 1000 mgSPR720 500 mg (250 mg × 4 capsules) was administered orally. | Drug | Investigator Blind: SPR720 1000 mg, Open-label: SPR720 1000 mg |
Primary outcome
Slope of the Weekly Sputum Log10 Colony Forming Units Per Millilitre (CFU/mL) Change From Day 1 Through 56 in micro-Intent to Treat (m-ITT) Population
Time frame: Days 1 through 56 (end of the treatment [EOT])
20 secondary outcomes
Slope of the Weekly Sputum Log10 CFU/mL Change From Days 1 Through 28 in micro-ITT Population
Time frame: Days 1 through 28
Slope of the Time to Positivity (TTP) using Mycobacteria Growth Indicator Tube (MGIT) on Samples of Induced Sputum From Days 1 Through 56 (EOT) in micro-ITT Population
Time frame: Days 1 through 56 (EOT)
Change from Baseline in the Sputum Log10 CFU/mL in the micro-ITT Population
Time frame: Days 1 through 56 (EOT)
Change from Baseline in the Sputum TTP Using MGIT in micro-ITT Population
Time frame: Days 1 through 56 (EOT)
Time to Negative Sputum Culture in micro-ITT Population
Time frame: Days 1 through 56 (EOT)
Percent with Negative Sputum Culture in micro-ITT Population
Time frame: Days 14 through Day 84 (FU)
Changes in Susceptibility in SPR719 From Days 1 through 56 (EOT) in the micro-ITT Population
Time frame: Days 1 through 56 (EOT)
Clinical Response in the micro-ITT Population
Time frame: Baseline up to Day 84 (FU)
Clinical Response in the Clinically Evaluable (CE) Populations
Time frame: Baseline up to Day 84 (FU)
Change From Baseline in 11-point Nontuberculous Mycobacteria Pulmonary Disease (NTM-PD) Symptoms and Impact Scale for Quality of Life (QOL) Assessments
Time frame: Baseline up to FU Day 84
Change From Baseline in 6-point Patient Global Impression of Severity (PGI-S) Scale for Quality of Life (QOL) Assessments
Time frame: Baseline up to FU Day 84
Change From Baseline in 7-point Patient Global Impression of Change (PGI-C) scale for Quality of Life (QOL) Assessments
Time frame: Baseline up to FU Day 84
Change From Baseline in Flu, COVID-19, or Other Illness Questionnaire (2 questions) for Quality of Life (QOL) Assessments
Time frame: Baseline up to FU Day 84
Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS®) V1.0 Fatigue Short form 7a scale for Quality of Life (QOL) Assessments
Time frame: Baseline up to FU Day 84
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: From first dose of study drug (Day 1) up to follow up Day 84
Maximum Plasma Concentration (Cmax) (Intensive PK group only)
Time frame: Pre-dose and post-dose on Days 1 and 14
Time to reach Cmax (Tmax) (Intensive PK group only)
Time frame: Pre-dose and post-dose on Days 1 and 14
Area Under the Concentration-time Curve (AUC0-τ) (Intensive PK group only)
Time frame: Pre-dose and post-dose on Days 1 and 14
Accumulation Ratio of SPR719 Cmax on Day 14 Compared to Day 1 (Intensive PK group only)
Time frame: Pre-dose and post-dose on Days 1 and 14
Accumulation Ratio of SPR719 AUC0-τ on Day 14 Compared to Day 1 (Intensive PK group only)
Time frame: Pre-dose and post-dose on Days 1 and 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
- Derived from this study: PubMed 41720869Ussery XT, Bhatt N, Critchley IA, Wong SL, Pottage JC Jr, Melnick D, Hamed KA. Randomized study of the efficacy, safety, and pharmacokinetics of SPR720 for the treatment of Mycobacterium avium complex pulmonary disease. Sci Rep. 2026 Feb 20;16(1):10063. doi: 10.1038/s41598-026-40505-7.
- Individual participant dataSharing planned: No
Related trials for Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD)
RecruitingObservational study
Rehabilitation Exercise and Education of Airway Clearance Technique in NTM-PD: A Prospective Cohort Study
Nontuberculous Mycobacterial Pulmonary Disease
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. This study is not recruiting at the moment.
Xilla Ussrey, MD study director
Spero Therapeutics Inc
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SPR720 500 mg and SPR720 1000 mg in people with Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD), run by Spero Therapeutics at 28 sites in United States.
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 21 inclusion and 7 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: finished, as of the sponsor's last update on 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Slope of the Weekly Sputum Log10 Colony Forming Units Per Millilitre (CFU/mL) Change From Day 1 Through 56 in micro-Intent to Treat (m-ITT) Population (time frame: Days 1 through 56 (end of the treatment [EOT])). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05496374, which also lists 1 linked publication.
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 9 Oct 2025.