Atypical; Mycobacterium, Pulmonary, Tuberculous Clinical Trial
— CAMOMYOfficial title:
Efficacy of Clarithromycin or Moxifloxacin Containing Regimen in 6 Months Sputum Conversion of Mycobacterium Xenopi
Verified date | July 2020 |
Source | Centre Hospitalier Universitaire, Amiens |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 92 |
Est. completion date | March 2019 |
Est. primary completion date | March 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | CH Abbeville | Abbeville | |
France | CHU Amiens | Amiens | |
France | CHU Angers | Angers | |
France | CH Argenteuil | Argenteuil | |
France | CHU Besançon | Besançon | |
France | CH Béthune | Béthune | |
France | Assistance Publique Hôpitaux de Paris CHU Avicenne | Bobigny | |
France | CHU Brest La Cavale | Brest | |
France | CHU Caen | Caen | |
France | CH Cannes | Cannes | |
France | CHU Clermont Ferrand Hôpital Gabriel Mont pied | Clermont Ferrand | |
France | CH Compiègne | Compiègne | |
France | CH Sud Francilien | Corbeil-Essonnes | |
France | Centre Intercommunal de Créteil | Creteil | |
France | CHU Dijon | Dijon | |
France | CH Gonesse | Gonesse | |
France | CHU Grenoble | Grenoble | |
France | Assistance Publique Hôpitaux de Paris Hôpital Bicetre | Le Kremlin-Bicêtre | |
France | CH Le MANS | Le Mans | |
France | CH Intercommunal Meulan | Les Mureaux | |
France | CHU Lille Hôpital Calmette | Lille | |
France | CHU Limoges Hôpital de Cluzeau | Limoges | |
France | CHU Lyon Hôpital La Croix Rousse | Lyon | |
France | Assistance Publique Hôpitaux de Marseille | Marseille | |
France | Hopital Saint-Joseph | Marseille | |
France | CHU Montpellier Hôpital Arnaud de Villeneuve | Montpellier | |
France | CHU Nantes | Nantes | |
France | CHU Nice | Nice | |
France | Chr Orleans | Orléans | |
France | Assistance Publique Hôpitaux de Paris Hôpital BICHAT | Paris | |
France | Assistance Publique Hôpitaux de Paris Hôpital Saint Antoine | Paris | |
France | Assistance Publique Hôpitaux de Paris Hôpital Saint Louis | Paris | |
France | Assistance Publique Hôpitaux de Paris, hôpital TENON | Paris | |
France | Centre National de Reference Des Mycobactéries | Paris | |
France | CHU Bordeaux Hôpital Haut Leveque | Pessac | |
France | CHU Poitiers | Poitiers | |
France | Hopital René DUBOS | Pontoise | |
France | CHU Reims | Reims | |
France | CHU de Rennes Hôpital Ponchaillou | Rennes | |
France | CH de Roubaix | Roubaix | |
France | CHU Rouen | Rouen | |
France | CHU de Saint Etienne | Saint Etienne | |
France | CH de Saint Quentin | Saint Quentin | |
France | CH Saint-Nazaire | Saint-Nazaire | |
France | CHU de Strasbourg | Strasbourg | |
France | Hôpital FOCH | Suresnes | |
France | CHU Toulouse | Toulouse | |
France | CH de Tourcoing | Tourcoing | |
France | CHU Tours Hôpital BRETONNEAU | Tours | |
France | CH Troyes | Troyes | |
France | CH de Valenciennes | Valenciennes | |
France | CHU Nancy | Vandœuvre-lès-Nancy |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire, Amiens |
France,
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* Note: There are 48 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 6 months | |
Secondary | 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) | 12 months | |
Secondary | 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 |
12 months | |
Secondary | 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 | 12 months | |
Secondary | 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 | 12 months |