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Atypical; Mycobacterium, Pulmonary, TuberculousPhase 3CAMOMYNCT01298336

Treatment of Mycobacterium Xenopi Pulmonary Infection

A Phase 3 study testing Clarithromycin and Moxifloxacin in people with Atypical; Mycobacterium, Pulmonary, Tuberculous, run by Centre Hospitalier Universitaire, Amiens at 52 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to determine the 6-months sputum conversion rate with a clarithromycin or moxifloxacin containing regimen in patients with a M. xenopi pulmonary infection. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Clarithromycin and Moxifloxacin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
52 sitesFrance
Study dates
2 Mar 2011to Mar 2019
Phase
Phase 3
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

  • 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
Show all 14Show fewer
  • 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

Who cannot join

  • 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%
Show all 15Show fewer
  • 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

Trial locations and contacts

52 sites in 1 country.

52 sites in 1 country

France52 sites

  • CH Abbeville

    Abbeville, 80142

  • CHU Amiens

    Amiens, 80054

  • CHU Angers

    Angers, 49033

  • CH Argenteuil

    Argenteuil, 95100

  • CHU Besançon

    Besançon, 25030

  • CH Béthune

    Béthune, 62408

  • Assistance Publique Hôpitaux de Paris CHU Avicenne

    Bobigny, 93009

  • CHU Brest La Cavale

    Brest, 29609

  • CHU Caen

    Caen, 14033

  • CH Cannes

    Cannes, 06401

  • CHU Clermont Ferrand Hôpital Gabriel Mont pied

    Clermont-Ferrand, 63000

  • CH Compiègne

    Compiègne, Compiègne, 60321

  • CH Sud Francilien

    Corbeil-Essonnes, 91100

  • Centre Intercommunal de Créteil

    Créteil, 94010

  • CHU Dijon

    Dijon, 21079

  • CH Gonesse

    Gonesse, 95503

  • CHU Grenoble

    Grenoble, 38043

  • Assistance Publique Hôpitaux de Paris Hôpital Bicetre

    Le Kremlin-Bicêtre, 94275

  • CH Le MANS

    Le Mans, 72037

  • CH Intercommunal Meulan

    Les Mureaux, Les Mureaux, 78250

  • CHU Lille Hôpital Calmette

    Lille, 59037

  • CHU Limoges Hôpital de Cluzeau

    Limoges, 87042

  • CHU Lyon Hôpital La Croix Rousse

    Lyon, 69004

  • Hopital Saint-Joseph

    Marseille, 13008

  • Assistance Publique Hôpitaux de Marseille

    Marseille, 13009

  • CHU Montpellier Hôpital Arnaud de Villeneuve

    Montpellier, 34295

  • CHU Nantes

    Nantes, 44000

  • CHU Nice

    Nice, 06002

  • Chr Orleans

    Orléans, 45067

  • Centre National de Reference Des Mycobactéries

    Paris, PARIS, 75013

  • Assistance Publique Hôpitaux de Paris Hôpital Saint Louis

    Paris, 75010

  • Assistance Publique Hôpitaux de Paris Hôpital Saint Antoine

    Paris, 75012

  • Assistance Publique Hôpitaux de Paris Hôpital BICHAT

    Paris, 75018

  • Assistance Publique Hôpitaux de Paris, hôpital TENON

    Paris, 75020

  • CHU Bordeaux Hôpital Haut Leveque

    Pessac, 33604

  • CHU Poitiers

    Poitiers, 86000

  • Hopital René DUBOS

    Pontoise, 95300

  • CHU Reims

    Reims, 51100

  • CHU de Rennes Hôpital Ponchaillou

    Rennes, 35033

  • CH de Roubaix

    Roubaix, 59056

  • CHU Rouen

    Rouen, 76031

  • CHU de Saint Etienne

    Saint-Etienne, 42055

  • CH Saint-Nazaire

    Saint-Nazaire, Saint-Nazaire, 44606

  • CH de Saint Quentin

    Saint-Quentin, 02100

  • CHU de Strasbourg

    Strasbourg, 67091

  • Hôpital FOCH

    Suresnes, 92150

  • CHU Toulouse

    Toulouse, 31059

  • CH de Tourcoing

    Tourcoing, 59208

  • CHU Tours Hôpital BRETONNEAU

    Tours, 37044

  • CH Troyes

    Troyes, Troyes, 10003

  • CH de Valenciennes

    Valenciennes, 59300

  • CHU Nancy

    Vandœuvre-lès-Nancy, 54511

Other trials in France

About this study

Official title: Efficacy of Clarithromycin or Moxifloxacin Containing Regimen in 6 Months Sputum Conversion of Mycobacterium Xenopi

The purpose of this study is to determine the 6-months sputum conversion rate with a clarithromycin or moxifloxacin containing regimen in patients with a M. xenopi pulmonary infection.

Read the detailed description

In France, Mycobacterium xenopi is the second non-tuberculous mycobacteria responsible of pulmonary infections. There are few data in the literature regarding its treatment apart from two small randomized trials (42 and 34 patients, respectively) and a French retrospective study (136 patients). So, we decided to conduct a prospective randomized multicenter study to evaluate two treatment regimens for Mycobacterium xenopi pulmonary infection in 6-months sputum conversion.

Main objective: To determine the 6-months sputum conversion rate with a clarithromycin or moxifloxacin containing regimen in patients with M.xenopi pulmonary infections according to ATS / IDSA 2007 criteria.

Secondary Objectives: To compare the rate of sputum conversion after 3 and 6 months of treatment the clinical and radiological outcome and the 12 months mortality.

primary endpoint : Result of culture of respiratory samples 6 months after starting treatment.Culture samples taken 6 months after starting treatment against M. xenopi is either positive (presence of M. xenopi colonies with or without smear positive) or negative with smear and culture negative (see data collection and measurement methods).

Study plan: Any patient with at least one positive pulmonary M. xenopi sample may be eligible. If the patient underwent ATS / IDSA 2007 criteria of M. xenopi pulmonary infection (after clinical , radiological and microbiological evaluation), in the absence of exclusion criteria, the patient will be randomized to one of the two treatment arms (rifampicin+ ethambutol + clarithromycin or rifampicin + ethambutol + moxifloxacin). A clinical, radiological, microbiological and pharmacological monitoring will be done for each randomized patient. The recommended treatment duration is 12 months after conversion with a maximum duration of 18 months.

Number of patients required: This is a prospective randomized study with 2 parallel groups. The primary endpoint is considered for the whole study population. For an α risk of 5%, an accuracy of 10%, an expected conversion rate of 70% a total of 80 patients is required . For a 15% rate of non evaluable patients (died, lost of follow-up) we need to include 92 patients.

Study Duration: Inclusion for 24 months with a minimum follow-up of 6 months (to meet the main objective), and if possible a follow-up of 12 months per patient to meet the overall objectives of the study.

Prospects: To establish new treatment recommendations for M.xenopi pulmonary infection, based on microbiological and clinical efficacy criteria and tolerance criteria.

Keywords
Mycobacterium Xenopi Pulmonary Infection, Clarithromycin, Moxifloxacin
Medical subject headings
Mycobacterium Infections, Latent Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ClarithromycinDrug

    Also called ZECLAR, NAXY

    500 mg twice a day seven days a week

  • MoxifloxacinDrug

    Also called IZILOX

    400 mg per day seven days a week

Study groups in NCT01298336
Study groupRoleWhat they receive
ClarithromycinExperimentalNot described
Receives: Drug: Clarithromycin
MoxifloxacinExperimentalNot described
Receives: Drug: Moxifloxacin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sputum conversion at 6 months under three antibiotics treatment (Rifampin, ethambutol and a third drug clarithromycin or moxifloxacin)

    Results of the smear and culture of three respiratory samples after 6 months of treatment.

    Measured: 6 months

Secondary outcomes (4)

  1. Sputum conversion at 3, 6, 9 and 12 months of treatment in the two different arms (clarithromycin containing regimen versus moxifloxacin containing regimen

    At each endpoint (3, 6, 9 and 12 months), respiratory sample will be analyzed (smear and culture) to answer the second objective (to compare microbiological efficacy of clarithromycin-containing regimen versus moxifloxacin-containing regimen)

    Measured: 12 months

  2. Clinical and radiological outcome after 3, 6 and 12 months of treatment according to the treatment arm

    At each end-point (3, 6 and 12 months) :

    • clinical evaluation with analogic scale (sputum, cough, dyspnea, chest pain, hemoptysis) and weight
    • radiological evaluation: comparison of the size and number of lesions at each endpoint with basal data

    Measured: 12 months

  3. Mortality after 12 months of treatment in the two compared regimen

    Mortality status will be evaluated after 12 months of treatment. In case of deaths under treatment, the date will be collected. Comparative survival analysis will be realized between the two arms of treatment

    Measured: 12 months

  4. Gastrointestinal toxicity and hematotoxicity after 1- 3- 6- 9- 12- months of treatment

    At each end point (1- 3- 6- 9- 12 months), Rhodes score (gastro-intestinal tolerance)and WHO score for hematological, and gastrointestinal toxicity will be collected in the two arms

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2011 (estimated)
  2. Study start2 Mar 2011
  3. Primary completionMar 2019
  4. Study completionMar 2019

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01298336
Sponsor's protocol ID
PHRCN10-DR-ANDREJAK-MELLE
Acronym
CAMOMY
Status last verified
Nov 2025
First submitted
15 Feb 2011
Last updated
19 Nov 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • Song JH, Yoon SY, Park TY, Heo EY, Kim DK, Chung HS, Lee JK. The clinical impact of drug-induced hepatotoxicity on anti-tuberculosis therapy: a case control study. Respir Res. 2019 Dec 16;20(1):283. doi: 10.1186/s12931-019-1256-y.

    PubMed 31842883

  • TIMPE A, RUNYON EH. The relationship of atypical acid-fast bacteria to human disease; a preliminary report. J Lab Clin Med. 1954 Aug;44(2):202-9. No abstract available.

    PubMed 13184228

  • RUNYON EH. Anonymous mycobacteria in pulmonary disease. Med Clin North Am. 1959 Jan;43(1):273-90. doi: 10.1016/s0025-7125(16)34193-1. No abstract available.

    PubMed 13612432

  • Griffith DE, Aksamit T, Brown-Elliott BA, Catanzaro A, Daley C, Gordin F, Holland SM, Horsburgh R, Huitt G, Iademarco MF, Iseman M, Olivier K, Ruoss S, von Reyn CF, Wallace RJ Jr, Winthrop K; ATS Mycobacterial Diseases Subcommittee; American Thoracic Society; Infectious Disease Society of America. An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases. Am J Respir Crit Care Med. 2007 Feb 15;175(4):367-416. doi: 10.1164/rccm.200604-571ST. No abstract available.

    PubMed 17277290

  • Falkinham JO 3rd. Nontuberculous mycobacteria in the environment. Clin Chest Med. 2002 Sep;23(3):529-51. doi: 10.1016/s0272-5231(02)00014-x.

    PubMed 12370991

  • von Reyn CF, Waddell RD, Eaton T, Arbeit RD, Maslow JN, Barber TW, Brindle RJ, Gilks CF, Lumio J, Lahdevirta J, et al. Isolation of Mycobacterium avium complex from water in the United States, Finland, Zaire, and Kenya. J Clin Microbiol. 1993 Dec;31(12):3227-30. doi: 10.1128/jcm.31.12.3227-3230.1993.

    PubMed 8308115

  • Smith MJ, Citron KM. Clinical review of pulmonary disease caused by Mycobacterium xenopi. Thorax. 1983 May;38(5):373-7. doi: 10.1136/thx.38.5.373.

    PubMed 6879487

  • Banks J, Hunter AM, Campbell IA, Jenkins PA, Smith AP. Pulmonary infection with mycobacterium xenopi: review of treatment and response. Thorax. 1984 May;39(5):376-82. doi: 10.1136/thx.39.5.376.

    PubMed 6740540

  • American Thoracic Society. Diagnosis standards and classification of tuberculosis and other mycobacterial diseases. New York: American Lung Association, 1974:25

  • Diagnosis and treatment of disease caused by nontuberculous mycobacteria. Am Rev Respir Dis. 1990 Oct;142(4):940-53. doi: 10.1164/ajrccm/142.4.940. No abstract available.

    PubMed 2282111

  • Diagnosis and treatment of disease caused by nontuberculous mycobacteria. This official statement of the American Thoracic Society was approved by the Board of Directors, March 1997. Medical Section of the American Lung Association. Am J Respir Crit Care Med. 1997 Aug;156(2 Pt 2):S1-25. doi: 10.1164/ajrccm.156.2.atsstatement.

    PubMed 9279284

  • Subcommittee OT. Management of opportunist mycobacterial infections: Joint Tuberculosis Committee Guidelines 1999. Subcommittee of the Joint Tuberculosis Committee of the British Thoracic Society. Thorax. 2000 Mar;55(3):210-8. doi: 10.1136/thorax.55.3.210. No abstract available.

    PubMed 10679540

  • Dailloux M, Abalain ML, Laurain C, Lebrun L, Loos-Ayav C, Lozniewski A, Maugein J; French Mycobacteria Study Group. Respiratory infections associated with nontuberculous mycobacteria in non-HIV patients. Eur Respir J. 2006 Dec;28(6):1211-5. doi: 10.1183/09031936.00063806.

    PubMed 17138678

  • Jenkins PA, Campbell IA; Research Committee of The British Thoracic Society. Pulmonary disease caused by Mycobacterium xenopi in HIV-negative patients: five year follow-up of patients receiving standardised treatment. Respir Med. 2003 Apr;97(4):439-44. doi: 10.1053/rmed.2002.1444.

    PubMed 12693807

  • Baugnee PE, Pouthier F, Delaunois L. [Pulmonary mycobacteriosis due to Mycobacterium xenopi" in-vitro sensitivity to classical antitubercular agents and clinical development]. Acta Clin Belg. 1996;51(1):19-27. French.

    PubMed 8669159

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Clarithromycin and Moxifloxacin in people with Atypical; Mycobacterium, Pulmonary, Tuberculous, run by Centre Hospitalier Universitaire, Amiens at 52 sites in France.

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 14 inclusion and 15 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 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in France. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Sputum conversion at 6 months under three antibiotics treatment (Rifampin, ethambutol and a third drug clarithromycin or moxifloxacin) (time frame: 6 months). 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 NCT01298336, which also lists 49 linked publications.

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 19 Nov 2025.

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