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New antibiotic combo aims to cut treatment time for stubborn lung infection

NCT ID NCT07213765

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding the antibiotic contezolid to standard drugs can shorten treatment for Mycobacterium Avium Complex (MAC) lung disease. About 188 adults with the nodular bronchiectatic form of the disease will either receive contezolid plus standard therapy for 6 months, or standard therapy alone for 12 months. Researchers will check if the combination leads to faster clearance of bacteria and better quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Contezolid (an antibiotic) added to a standard regimen of azithromycin, ethambutol, and rifampicin
What this could lead to
If it works, this could lead to a shorter, more effective treatment for MAC lung disease, reducing the time patients need to take antibiotics.
What could go wrong
This is a Phase 4 trial with 188 participants, so results are not yet proven. Adding a new drug may cause side effects or not improve outcomes compared to standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 188 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients voluntarily participate in this study and sign the Informed Consent Form. 2. Age ≥ 18 years and ≤75 years; gender unrestricted. 3. Confirmed diagnosis of MAC pulmonary disease per ATS/IDSA 2020 guidelines or Chinese Guidelines for Diagnosis and Treatment of Nontuberculous Mycobacterial Diseases (2020 edition), with imaging features consistent with nodular bronchiectatic type. 4. No prior anti-MAC treatment within the 3 months preceding screening. 5. For premenopausal women of childbearing potential who are not surgically sterile: Must use a medically accepted contraceptive method (e.g., intrauterine device, hormonal contraception, or condom) during the study period and for 3 months following the last dose of investigational treatment. Serum or urine human chorionic gonadotropin (hCG) test must be negative within 72 hours prior to enrollment. Must not be breastfeeding. Male patients with partners of childbearing potential must use effective contraception during the study period and for 3 months after the last dose. 6. Organ function criteria met within one week prior to enrollment: i. Hemoglobin ≥60 g/L; ii. Neutrophil count ≥0.5 × 10⁹/L; iii. Platelet count ≥60 × 10⁹/L; iv. Serum total bilirubin ≤3 × upper limit of normal (ULN); v. Aspartate aminotransferase (AST) ≤3 × ULN; vi. Alanine aminotransferase (ALT) ≤3 × ULN; vii. Serum creatinine \<2 × ULN OR creatinine clearance ≥60 mL/min; viii. Blood urea nitrogen (BUN) ≤200 mg/L; ix. Urinalysis: Proteinuria \<++; if proteinuria is +, 24-hour total protein must be \<500 mg. x. Fasting blood glucose within normal range OR stable glycemic control in diabetic patients. xi. Cardiac function: No myocardial infarction in the preceding 6 months; No unstable angina or severe arrhythmias; New York Heart Association (NYHA) functional class \>II. Exclusion Criteria: 1. History of allergy to any study drug in the treatment regimen. 2. Mixed infections with multiple mycobacteria, bacteria, fungi, or viruses (e.g., HIV coinfection). 3. Presence of congenital/acquired immunodeficiency disorders, active pulmonary malignancy (primary or metastatic), or other malignancies requiring chemotherapy/radiation therapy during the screening or study period. 4. History of solid organ transplantation. 5. Currently undergoing dialysis. 6. Uncontrolled radiation pneumonitis requiring steroid or immunoglobulin pulse therapy, active interstitial lung disease with clinical evidence, uncontrolled and significant pleural effusion or pericardial effusion. 7. Unstable systemic comorbidities including: Hypertensive crisis; Unstable angina; Congestive heart failure (NYHA Class III/IV); Myocardial infarction within the preceding 6 months; Severe psychiatric disorders requiring medication (e.g., schizophrenia, bipolar disorder); Severe hepatic or renal dysfunction (e.g., Child-Pugh Class C cirrhosis, eGFR \<30 mL/min/1.73m²); Neurodegenerative diseases (e.g., Alzheimer's disease). 8. Poor gastrointestinal function or malabsorption syndrome. 9. Receipt of other investigational drugs within 4 weeks prior to the first study drug administration. 10. Concurrent participation in another interventional clinical trial, unless it is an observational/noninterventional study OR follow-up phase of a completed intervention trial. 11. Any physical examination findings or clinical tests deemed by the investigator as likely to: Interfere with study results; Increase risks of complications during treatment.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Anhui Chest Hospital

    RECRUITING

    Hefei, Anhui, China

  • Beijing Chest Hospital, Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, China

  • China-Japan Friendship Hospital

    RECRUITING

    Beijing, Beijing Municipality, China

  • Guangzhou Chest Hospital

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, China

  • Jiangxi Chest Hospital

    RECRUITING

    Nanchang, Jiangxi, China

  • Shanghai Pulmonary Hospital

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, China

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