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New hope for stubborn lung infection: bedaquiline combo shows promise

NCT ID NCT04630145

Disease control Sponsor: Janssen Pharmaceutical K.K. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding bedaquiline to two standard antibiotics (clarithromycin and ethambutol) helps clear a stubborn lung infection called MAC lung disease. 129 adults who had not responded to previous treatment took part. The main goal was to see if the new combination could make sputum samples bacteria-free by week 24.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

129 people

The number who actually took part.

Started

Jan 2021

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

20 to 79 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: * Has body weight greater than or equal to (\>=) 40 kilograms (kg) at screening and on Day 1 * Has radiological evidence consistent with nontuberculous mycobacterial lung disease (NTM-LD) based on a chest Computed Tomography (CT) scan taken within 6 months prior to screening or at screening * Has at least 2 positive sputum cultures of Mycobacterium avium complex (MAC) (sputum cultures to be taken at least 4 weeks apart): one obtained within 12 months prior to screening, which was documented while being treated for Mycobacterium avium complex lung disease (MAC-LD) for a total of at least 6 months; and one at screening (by central microbiology laboratory) * Received at least 6 months of consecutive MAC-LD treatment (at least 2 antibiotics for MAC, including a macrolide), that is either ongoing or has stopped within 12 months prior to screening * No presence of cognitive dysfunction that would impact the completion of the patient reported outcome (PRO) assessments Exclusion Criteria: * Had previous exposure to bedaquiline (BDQ) * Has active Tuberculosis (TB) disease * Has cystic fibrosis, medically unstable respiratory disease (for example, chronic obstructive pulmonary disease, bronchiectasis, asthma) * Has one or more cavities \>=2 centimeter (cm) in diameter on a chest CT scan taken within 6 months prior to screening or at screening * Treatment already includes an injectable/inhaled aminoglycoside within 3 months prior to screening or the investigator deems the participant to be a candidate for an injectable/inhaled aminoglycoside during screening period or at Day 1

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Conditions

The condition(s) this trial relates to.

Mycobacterium avium complex disease pulmonary non-tuberculous mycobacterial infection

As listed by the trial registrant

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

Treatment-refractory mycobacterium avium complex-lung disease (mac-LD)

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Chonnam National University Hospital

    Gwangju, 61469, South Korea

  • Fukui Prefectural Hospital

    Fukui-shi, 910-0846, Japan

  • Fukujuji Hospital

    Kiyose, 204-0022, Japan

  • Fukuoka University Chikushi Hospital

    Chikushino-shi, 818-8502, Japan

  • Gifu Prefectural General Medical Center

    Gifu, 500-8717, Japan

  • Hamamatsu Rosai Hospital

    Hamamatsu, 430-8525, Japan

  • Hokkaido Medical Center

    Sapporo Nishi-Ku, 063-0005, Japan

  • JRC Wakayama Medical Center

    Wakayama, 640 8558, Japan

  • Kanagawa Cardiovascular And Respiratory Center

    Yokohama, 236-0051, Japan

  • Kaohsiung Medical University Chung Ho Memorial Hospital

    Kaohsiung City, 80756, Taiwan

  • Keio University Hospital

    Shinjuku-ku, 160-8582, Japan

  • Kinki-chuo Chest Medical Center

    Sakai, 591-8555, Japan

  • Kobe City Medical Center West Hospital

    Kobe Nagata-Ku, 653-0013, Japan

  • Kojunkai Daido Clinic

    Nagoya, 457-8511, Japan

  • Matsunami General Hospital

    Hashima-gun, 501-6062, Japan

  • Matsunami Health Promotion Clinic

    Hashimagun Kasamatsucho, 501-6062, Japan

  • Matsusaka Municipal Hospital

    Matsusaka, 515-8544, Japan

  • Musashino Red Cross Hospital

    Musashino, 180-8610, Japan

  • Nagano Prefectural Shinshu Medical Center

    Suzaka, 386-8610, Japan

  • Nagaoka Red Cross Hospital

    Nagaoka, 940-2085, Japan

  • Nagasaki University Hospital

    Nagasaki, 852-8501, Japan

  • National Center for Global Health and Medicine

    Shinjuku, 162-8655, Japan

  • National Hospital Organization Ehime Medical Center

    Tōon, 791-0281, Japan

  • National Hospital Organization Fukuoka Higashi Medical Center

    Koga, 811-3195, Japan

  • National Hospital Organization Himeji Medical Center

    Himeji, 670-8520, Japan

  • National Hospital Organization Ibarakihigashi

    Funaishikawa, 319-1113, Japan

  • National Hospital Organization Kochi National Hospital

    Kochi, 780-8077, Japan

  • National Hospital Organization Kyoto Medical Center

    Kyoto, 612-8555, Japan

  • National Hospital Organization Minami Kyoto Hospital

    Jōyō, 610-0113, Japan

  • National Hospital Organization Nagoya Medical Center

    Nagoya, 460-0001, Japan

  • National Hospital Organization Nara Medical Center

    Shichijō, 630-8053, Japan

  • National Hospital Organization Nishiniigata Chuo Hospital

    Niigata, 950-2085, Japan

  • National Hospital Organization Omuta Hospital

    Omuta, 837-0911, Japan

  • National Hospital Organization Osaka Toneyama Medical Center

    Toyonaka-shi, 560-8552, Japan

  • National Hospital Organization Sagamihara National Hospital

    Sagamihara, 252-0392, Japan

  • National Hospital Organization Tenryu Hospital

    Hamamatue, 434-8511, Japan

  • National Hospital Organization Tokyo Medical Center

    Tokyo, 152-8902, Japan

  • National Hospital Organization Tokyo National Hospital

    Tokyo, 204-8585, Japan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • Rakuwakai Otowa Hospital

    Kyoto, 607-8062, Japan

  • Saitama City Hospital

    Saitama-shi, 336-8522, Japan

  • Saitama Medical University Hospital

    Iruma-gun, 350-0495, Japan

  • Saitama Prefectural Cardiovascular and Respiratory Center

    Kumagaya, 360-0197, Japan

  • Samsung Medical Center

    Seoul, 135-230, South Korea

  • Seirei Hamamatsu General Hospital

    Hamamatsu, 430-8558, Japan

  • Shimonoseki City Hospital

    Yamaguchi, 750-0041, Japan

  • St. Luke's International Hospital

    Chūōku, 104 8560, Japan

  • Taichung Veterans General Hospital

    Taichung, 40705, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 112, Taiwan

  • The Catholic University of Korea, Incheon St. Mary's Hospital

    Incheon, 403-720, South Korea

  • Tohoku Medical And Pharmaceutical University Hospital

    Sendai, 983-8512, Japan

  • Tokyo Shinagawa Hospital

    Shinagawa-ku, 140-8522, Japan

  • Toyota Kosei Hospital

    Toyota, 470-0396, Japan

  • Toyota Memorial Hospital

    Toyota-shi, 471-8513, Japan