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Cure My Disease

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Which antibiotic wins against this tough lung bug?

NCT ID NCT01298336

Disease control Sponsor: Centre Hospitalier Universitaire, Amiens 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested two different antibiotics—clarithromycin or moxifloxacin—alongside standard drugs to treat a rare lung infection caused by M. xenopi bacteria. Researchers tracked whether patients' sputum samples became bacteria-free after 6 months. The goal was to find the more effective combination to control the infection.

What this could mean

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

Active substance
clarithromycin or moxifloxacin (antibiotics)
What this could lead to
If successful, this could show which antibiotic combination works better to clear M. xenopi lung infections, improving treatment guidelines.
What could go wrong
This is a completed Phase 3 trial with only 92 participants, so results may not apply to all patients. Antibiotics can cause side effects like stomach upset or allergic reactions.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

92 people

The number who actually took part.

Started

Mar 2011

Finished

Mar 2019

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 years and older

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: * The patient and/or legal representative of the patient has provided a written informed consent before inclusion in the study * The patient is aged 18 or older * The patient has signs of functional respiratory (cough, sputum, hemoptysis, dyspnea, chest pain and / or general signs (asthenia and / or anorexia and / or weight loss) * The patient has a creatinine clearance above 30 ml / min * The patient underwent a thoracic scan not older than one month before the first positive bacteriological sample. * The patient underwent a bronchoscopy with sampling conducted in the territory corresponding to the radiographic * The most plausible alternative diagnostics have been eliminated using the thoracic scan and bronchoscopy * The patient has at least two positive cultures for M. xenopi sputum collected on two separate days AND/OR a positive culture for M. xenopi in a bronchoalveolar lavage or bronchial aspiration directed AND / OR transbronchial biopsy or lung biopsy with surgical histology for a mycobacterial infection (granuloma or Ziehl positive) and a culture positive M. xenopi, AND / OR biopsy with histology compatible with mycobacteriosis and one or more positive sputum culture for M . xenopi * The patient is willing and able to take the study treatment throughout the duration * If this is a woman of childbearing age, the patient is ready to use for the duration of the test contraception method other than estrogen-progestin * The patient did not participate in another study evaluating an investigational drug within 30 days prior to enrollment in the study and agrees not to participate in another study for the duration of the study * The patient is informed by the doctor and agreed that its data are processed in this study * The patient understands / reads French and has no difficulty understanding the objectives of the study * The patient has health insurance coverage Exclusion Criteria: * Hypersensitivity to any of the molecules (rifampicin, ethambutol, moxifloxacin, clarithromycin) * Any patient with a relapse of a lung infection with M. xenopi * The patient is treated with molecules that can interfere with cytochrome P450 and can not be replaced by another therapeutic class * The patient is treated by prolonging the QT molecules which can not be replaced by another therapeutic class * The patient is treated with alkaloid of ergot, cisapride, biperidil, pimozide, mizolastine * The patient has heart failure with left ventricular ejection fraction below 30% * Discovered on the balance sheet or history, we find that the patient infection with human immunodeficiency virus HIV 1 and 2 a long QT on ECG and / or arrhythmias or clinically significant bradycardia judged by the investigator cytolysis with transaminases increase more than 5 times normal renal failure with creatinine clearance below 30 ml / min * The patient has cirrhosis Child Pugh C and / or porphyria * There pregnancy or during breastfeeding * The patient has an inability to meet the protocol requirements, including active substance abuse, according to the investigator. * The patient has a history of tendinopathy with a fluoroquinolone * The patient has a congenital galactosemia, malabsorption of glucose and galactose, or lactase deficiency * The patient has a NORB (abnormalities of the visual field or color vision tested by an eye examination prior) * Any other situation that, in the opinion of the investigator, would imply that participation in the study is not in the interest of the patient * There is a risk of difficulty of monitoring, such as imminent transfer to a different region or country

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Conditions

The condition(s) this trial relates to.

latent tuberculosis infection mycobacterial infectious disease Mycobacterium xenopi infection pulmonary tuberculosis

As listed by the trial registrant

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

Atypical; mycobacterium, pulmonary, tuberculous

Contacts and locations

Locations

  • Assistance Publique Hôpitaux de Marseille

    Marseille, 13009, France

  • Assistance Publique Hôpitaux de Paris CHU Avicenne

    Bobigny, 93009, France

  • Assistance Publique Hôpitaux de Paris Hôpital BICHAT

    Paris, 75018, France

  • Assistance Publique Hôpitaux de Paris Hôpital Bicetre

    Le Kremlin-Bicêtre, 94275, France

  • Assistance Publique Hôpitaux de Paris Hôpital Saint Antoine

    Paris, 75012, France

  • Assistance Publique Hôpitaux de Paris Hôpital Saint Louis

    Paris, 75010, France

  • Assistance Publique Hôpitaux de Paris, hôpital TENON

    Paris, 75020, France

  • CH Abbeville

    Abbeville, 80142, France

  • CH Argenteuil

    Argenteuil, 95100, France

  • CH Béthune

    Béthune, 62408, France

  • CH Cannes

    Cannes, 06401, France

  • CH Compiègne

    Compiègne, Compiègne, 60321, France

  • CH Gonesse

    Gonesse, 95503, France

  • CH Intercommunal Meulan

    Les Mureaux, Les Mureaux, 78250, France

  • CH Le MANS

    Le Mans, 72037, France

  • CH Saint-Nazaire

    Saint-Nazaire, Saint-Nazaire, 44606, France

  • CH Sud Francilien

    Corbeil-Essonnes, 91100, France

  • CH Troyes

    Troyes, Troyes, 10003, France

  • CH de Roubaix

    Roubaix, 59056, France

  • CH de Saint Quentin

    Saint-Quentin, 02100, France

  • CH de Tourcoing

    Tourcoing, 59208, France

  • CH de Valenciennes

    Valenciennes, 59300, France

  • CHU Amiens

    Amiens, 80054, France

  • CHU Angers

    Angers, 49033, France

  • CHU Besançon

    Besançon, 25030, France

  • CHU Bordeaux Hôpital Haut Leveque

    Pessac, 33604, France

  • CHU Brest La Cavale

    Brest, 29609, France

  • CHU Caen

    Caen, 14033, France

  • CHU Clermont Ferrand Hôpital Gabriel Mont pied

    Clermont-Ferrand, 63000, France

  • CHU Dijon

    Dijon, 21079, France

  • CHU Grenoble

    Grenoble, 38043, France

  • CHU Lille Hôpital Calmette

    Lille, 59037, France

  • CHU Limoges Hôpital de Cluzeau

    Limoges, 87042, France

  • CHU Lyon Hôpital La Croix Rousse

    Lyon, 69004, France

  • CHU Montpellier Hôpital Arnaud de Villeneuve

    Montpellier, 34295, France

  • CHU Nancy

    Vandœuvre-lès-Nancy, 54511, France

  • CHU Nantes

    Nantes, 44000, France

  • CHU Nice

    Nice, 06002, France

  • CHU Poitiers

    Poitiers, 86000, France

  • CHU Reims

    Reims, 51100, France

  • CHU Rouen

    Rouen, 76031, France

  • CHU Toulouse

    Toulouse, 31059, France

  • CHU Tours Hôpital BRETONNEAU

    Tours, 37044, France

  • CHU de Rennes Hôpital Ponchaillou

    Rennes, 35033, France

  • CHU de Saint Etienne

    Saint-Etienne, 42055, France

  • CHU de Strasbourg

    Strasbourg, 67091, France

  • Centre Intercommunal de Créteil

    Créteil, 94010, France

  • Centre National de Reference Des Mycobactéries

    Paris, PARIS, 75013, France

  • Chr Orleans

    Orléans, 45067, France

  • Hopital René DUBOS

    Pontoise, 95300, France

  • Hopital Saint-Joseph

    Marseille, 13008, France

  • Hôpital FOCH

    Suresnes, 92150, France