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New drug combo aims to knock out stubborn lung bug
NCT ID NCT07084402
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study tests whether adding the antibiotic contezolid to the usual three-drug regimen can better reduce bacteria in the sputum of adults with Mycobacterium avium complex (MAC) lung disease. About 188 participants will receive either the standard treatment alone or with contezolid for six months. Researchers will track how quickly the bacteria clear and monitor for side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- contezolid
- What this could lead to
- If it works, adding contezolid to standard drugs could help clear the lung infection faster and more effectively for people with MAC pulmonary disease.
- What could go wrong
- This is a Phase 4 trial, but it's still early for this specific combination. The benefit may be small, and contezolid could cause side effects like any antibiotic. Results may not apply to all patients.
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 188 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Beijing Chest Hospital, Capital Medical University
ACTIVE_NOT_RECRUITINGBeijing, Beijing Municipality, China
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China-Japan Friendship Hospital
RECRUITINGBeijing, Beijing Municipality, China
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Jiangxi Provincial Chest Hospital
RECRUITINGNanchang, Jiangxi, China
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