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Treatment of Mycobacterium Xenopi Pulmonary Infection (CAMOMY)

Primary Purpose

Atypical; Mycobacterium, Pulmonary, Tuberculous

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Clarithromycin
Moxifloxacin
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atypical; Mycobacterium, Pulmonary, Tuberculous focused on measuring Mycobacterium Xenopi Pulmonary Infection, Clarithromycin, Moxifloxacin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CH Abbeville
  • CHU Amiens
  • CHU Angers
  • CH Argenteuil
  • CHU Besançon
  • Assistance Publique Hôpitaux de Paris CHU Avicenne
  • CHU Brest La Cavale
  • CH Béthune
  • CHU Caen
  • CH Cannes
  • CHU Clermont Ferrand Hôpital Gabriel Mont pied
  • CH Compiègne
  • CH Sud Francilien
  • Centre Intercommunal de Créteil
  • CHU Dijon
  • CH Gonesse
  • CHU Grenoble
  • Assistance Publique Hôpitaux de Paris Hôpital Bicetre
  • CH Le MANS
  • CH Intercommunal Meulan
  • CHU Lille Hôpital Calmette
  • CHU Limoges Hôpital de Cluzeau
  • CHU Lyon Hôpital La Croix Rousse
  • Hopital Saint-Joseph
  • Assistance Publique Hôpitaux de Marseille
  • CHU Montpellier Hôpital Arnaud de Villeneuve
  • CHU Nantes
  • CHU Nice
  • Chr Orleans
  • Assistance Publique Hôpitaux de Paris Hôpital Saint Louis
  • Assistance Publique Hôpitaux de Paris Hôpital Saint Antoine
  • Centre National de Reference Des Mycobactéries
  • Assistance Publique Hôpitaux de Paris Hôpital BICHAT
  • Assistance Publique Hôpitaux de Paris, hôpital TENON
  • CHU Bordeaux Hôpital Haut Leveque
  • CHU Poitiers
  • Hopital René DUBOS
  • CHU Reims
  • CHU de Rennes Hôpital Ponchaillou
  • CH de Roubaix
  • CHU Rouen
  • CHU de Saint Etienne
  • CH de Saint Quentin
  • CH Saint-Nazaire
  • CHU de Strasbourg
  • Hôpital FOCH
  • CHU Toulouse
  • CH de Tourcoing
  • CHU Tours Hôpital BRETONNEAU
  • CH Troyes
  • CH de Valenciennes
  • CHU Nancy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Clarithromycin

Moxifloxacin

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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
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
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

Full Information

First Posted
February 15, 2011
Last Updated
July 17, 2020
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT01298336
Brief Title
Treatment of Mycobacterium Xenopi Pulmonary Infection
Acronym
CAMOMY
Official Title
Efficacy of Clarithromycin or Moxifloxacin Containing Regimen in 6 Months Sputum Conversion of Mycobacterium Xenopi
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 2, 2011 (Actual)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atypical; Mycobacterium, Pulmonary, Tuberculous
Keywords
Mycobacterium Xenopi Pulmonary Infection, Clarithromycin, Moxifloxacin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clarithromycin
Arm Type
Experimental
Arm Title
Moxifloxacin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Clarithromycin
Other Intervention Name(s)
ZECLAR, NAXY
Intervention Description
500 mg twice a day seven days a week
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin
Other Intervention Name(s)
IZILOX
Intervention Description
400 mg per day seven days a week
Primary Outcome Measure Information:
Title
Sputum conversion at 6 months under three antibiotics treatment (Rifampin, ethambutol and a third drug clarithromycin or moxifloxacin)
Description
Results of the smear and culture of three respiratory samples after 6 months of treatment.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Sputum conversion at 3, 6, 9 and 12 months of treatment in the two different arms (clarithromycin containing regimen versus moxifloxacin containing regimen
Description
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)
Time Frame
12 months
Title
Clinical and radiological outcome after 3, 6 and 12 months of treatment according to the treatment arm
Description
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
Time Frame
12 months
Title
Mortality after 12 months of treatment in the two compared regimen
Description
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
Time Frame
12 months
Title
Gastrointestinal toxicity and hematotoxicity after 1- 3- 6- 9- 12- months of treatment
Description
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
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire ANDREJAK, Dr
Organizational Affiliation
Centre Hospitalier Universitaire, Amiens
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Claire ANDREJAK, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vincent JOUNIEAUX, MD PhD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nicolas VEZIRIS, MD-PhD
Organizational Affiliation
APHP Pitie Salpetriere Hospital, National Center Of Mycobacteria
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jacques CADRANEL, MD PhD
Organizational Affiliation
Tenon Hospital APHP Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francois-Xavier LESCURE, MD
Organizational Affiliation
Tenon hospital APHP Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Abbeville
City
Abbeville
ZIP/Postal Code
80142
Country
France
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
CH Argenteuil
City
Argenteuil
ZIP/Postal Code
95100
Country
France
Facility Name
CHU Besançon
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
Assistance Publique Hôpitaux de Paris CHU Avicenne
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
CHU Brest La Cavale
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
CH Béthune
City
Béthune
ZIP/Postal Code
62408
Country
France
Facility Name
CHU Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
CH Cannes
City
Cannes
ZIP/Postal Code
06401
Country
France
Facility Name
CHU Clermont Ferrand Hôpital Gabriel Mont pied
City
Clermont Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
CH Compiègne
City
Compiègne
ZIP/Postal Code
60321
Country
France
Facility Name
CH Sud Francilien
City
Corbeil-Essonnes
ZIP/Postal Code
91100
Country
France
Facility Name
Centre Intercommunal de Créteil
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
CHU Dijon
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
CH Gonesse
City
Gonesse
ZIP/Postal Code
95503
Country
France
Facility Name
CHU Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Assistance Publique Hôpitaux de Paris Hôpital Bicetre
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94275
Country
France
Facility Name
CH Le MANS
City
Le Mans
ZIP/Postal Code
72037
Country
France
Facility Name
CH Intercommunal Meulan
City
Les Mureaux
ZIP/Postal Code
78250
Country
France
Facility Name
CHU Lille Hôpital Calmette
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHU Limoges Hôpital de Cluzeau
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
CHU Lyon Hôpital La Croix Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
Hopital Saint-Joseph
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
Assistance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
CHU Montpellier Hôpital Arnaud de Villeneuve
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
CHU Nice
City
Nice
ZIP/Postal Code
06002
Country
France
Facility Name
Chr Orleans
City
Orléans
ZIP/Postal Code
45067
Country
France
Facility Name
Assistance Publique Hôpitaux de Paris Hôpital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Assistance Publique Hôpitaux de Paris Hôpital Saint Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Centre National de Reference Des Mycobactéries
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Assistance Publique Hôpitaux de Paris Hôpital BICHAT
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Assistance Publique Hôpitaux de Paris, hôpital TENON
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
CHU Bordeaux Hôpital Haut Leveque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
CHU Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
Hopital René DUBOS
City
Pontoise
ZIP/Postal Code
95300
Country
France
Facility Name
CHU Reims
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
CHU de Rennes Hôpital Ponchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
CH de Roubaix
City
Roubaix
ZIP/Postal Code
59056
Country
France
Facility Name
CHU Rouen
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
CHU de Saint Etienne
City
Saint Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
CH de Saint Quentin
City
Saint Quentin
ZIP/Postal Code
02100
Country
France
Facility Name
CH Saint-Nazaire
City
Saint-Nazaire
ZIP/Postal Code
44606
Country
France
Facility Name
CHU de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Hôpital FOCH
City
Suresnes
ZIP/Postal Code
92150
Country
France
Facility Name
CHU Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
CH de Tourcoing
City
Tourcoing
ZIP/Postal Code
59208
Country
France
Facility Name
CHU Tours Hôpital BRETONNEAU
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
CH Troyes
City
Troyes
ZIP/Postal Code
10003
Country
France
Facility Name
CH de Valenciennes
City
Valenciennes
ZIP/Postal Code
59300
Country
France
Facility Name
CHU Nancy
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54511
Country
France

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Treatment of Mycobacterium Xenopi Pulmonary Infection

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