Treatment of Mycobacterium Xenopi Pulmonary Infection

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01298336
• Date of registration: 15/02/2011
• Prospective Registration: Yes
• Primary sponsor: Centre Hospitalier Universitaire, Amiens
• Public title: Treatment of Mycobacterium Xenopi Pulmonary Infection CAMOMY
• Scientific title: Efficacy of Clarithromycin or Moxifloxacin Containing Regimen in 6 Months Sputum Conversion of Mycobacterium Xenopi
• Date of first enrolment: March 2, 2011
• Target sample size: 92
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01298336
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Francois-Xavier LESCURE, MD
• Affiliation: Tenon hospital APHP Paris

• Name: Claire ANDREJAK, Dr
• Affiliation: Centre Hospitalier Universitaire, Amiens

• Name: Vincent JOUNIEAUX, MD PhD
• Affiliation: CHU Amiens

• Name: Nicolas VEZIRIS, MD-PhD
• Affiliation: APHP Pitie Salpetriere Hospital, National Center Of Mycobacteria

• Name: Claire ANDREJAK, MD
• Affiliation: CHU Amiens

• Name: Jacques CADRANEL, MD PhD
• Affiliation: Tenon Hospital APHP Paris

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Atypical; Mycobacterium, Pulmonary, Tuberculous

Intervention(s)

Drug: Moxifloxacin

Drug: Clarithromycin

Primary Outcome(s)

Sputum conversion at 6 months under three antibiotics treatment (Rifampin, ethambutol and a third drug clarithromycin or moxifloxacin) [Time Frame: 6 months]

Secondary Outcome(s)

Sputum conversion at 3, 6, 9 and 12 months of treatment in the two different arms (clarithromycin containing regimen versus moxifloxacin containing regimen [Time Frame: 12 months]

Mortality after 12 months of treatment in the two compared regimen [Time Frame: 12 months]

Clinical and radiological outcome after 3, 6 and 12 months of treatment according to the treatment arm [Time Frame: 12 months]

Gastrointestinal toxicity and hematotoxicity after 1- 3- 6- 9- 12- months of treatment [Time Frame: 12 months]

Secondary ID(s)

PHRCN10-DR-ANDREJAK-MELLE

Source(s) of Monetary Support

Please refer to primary and secondary sponsors