Clinical trial • Infectious Disease
RIFAMPICIN for Mycobacterium avium complex (MAC) pulmonary infection
Clinical trial of RIFAMPICIN for Mycobacterium avium complex (MAC) pulmonary infection.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Mycobacterium avium complex (MAC) pulmonary infection
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 04-10-2024
- First CTIS Authorization Date
- 30-10-2024
Trial design
Randomised, comparator arm: clarithromycin (clarithromycine arrow 500 mg, modified-release tablet; maximum daily dose listed as 1000 mg). test arm: azithromycin-containing regimen (azithromycine teva 250 mg, film-coated tablet; maximum daily dose listed as 250 mg). both regimens include combination with other study antibiotics (rifadine (rifampicin) and dexambutol (ethambutol)) as part of the treatment regimens.-controlled trial across 60 sites in France.
- Randomised
- Yes
- Comparator
- Comparator arm: Clarithromycin (CLARITHROMYCINE ARROW 500 mg, modified-release tablet; maximum daily dose listed as 1000 mg). Test arm: Azithromycin-containing regimen (AZITHROMYCINE TEVA 250 mg, film-coated tablet; maximum daily dose listed as 250 mg). Both regimens include combination with other study antibiotics (RIFADINE (rifampicin) and DEXAMBUTOL (ethambutol)) as part of the treatment regimens.
- Target Sample Size
- 424
- Trial Duration For Participant
- 365
Eligibility
Recruits 424 Vulnerable population not selected. Participants are adults (18 years or older). Informed consent is obtained from adult participants; subject information and informed consent form documents (L1_SIS Adults, ICF Patients) are provided. No assent/parental consent procedures for children are described..
- Pregnancy Exclusion
- Pregnancy and breastfeeding
- Vulnerable Population
- Vulnerable population not selected. Participants are adults (18 years or older). Informed consent is obtained from adult participants; subject information and informed consent form documents (L1_SIS Adults, ICF Patients) are provided. No assent/parental consent procedures for children are described.
Inclusion criteria
- {"criterion_text":"- In order to be included, each eligible patient, 18 years old or orlder, must present ATS/IDSA 2007 criteria for nontuberculous mycobacterial pulmonary infection (3). These criteria are as follows: - Clinical criteria o Respiratory symptoms and the presence of nodular or cavitary lesion on chest highresolution computed tomography. Lesions may also present in the form of diffuse micronodular syndrome.\n- AND Microbiological criteria : At least two positive cultures for MAC on two sputum specimens obtained on two different days collected at lesast 7 days apart\n- AND/OR : Positive culture for MAC on bronchoalveolar lavage or bronchoscopic aspiration\n- AND/OR : Transbronchial biopsy or surgical lung biopsy presenting histology in favour of mycobacterial infection (granuloma or positive Ziehl-Neelsen stain) and positive culture for MAC OR biopsy showing histology compatible with mycobacterial infection and one or more sputum cultures positive for MAC\n- AND : Exclusion of other diagnoses more likely than Mycobacterium avium infection on CT scan, bronchoscopy or bacteriological specimens (Bronchoscopy is not required if two good-quality sputum samples, collected 7 days apart, are available)In the presence of common bacteria, persistence of clinical symptoms and radiological signs after well-conducted antibiotic therapy suggests the diagnosis of MAC infection. The presence of criteria of Aspergillus fumigatus infection associated with the presence of microbiological criteria of MAC infection will lead to the diagnosis of MAC and Aspergillus fumigatus co-infection."}
Exclusion criteria
- {"criterion_text":"- Known hypersensitivity to one of the molecules of the study (rifampin, ethambutol, azithromycin, clarithromycin)\n- Limited life expectancy (e.g 6 months)\n- Patients with hematologic malignancies and allogeneic haematopoietic stem cells\n- Women of childbearing age and not using an effective method of contraception (Pearl Index <1%)\n- The patient is treated with molecules prolonging the QT interval that cannot be replaced by another therapeutic class\n- The patient presents a heart failure with left ventricular ejection fraction less than 30%\n- Patient already participating in a clinical trial of a treatment or a therapeutic strategy for non-mycobacterial Tubercular\n- Relapse of MAC lung infection\n- Macrolide resistant strain, based on genotyping susceptibility testing (must be done before inclusion)\n- Treatment with molecules able to interfere with cytochrome P450 that cannot be replaced by another therapeutic class\n- HIV 1 and 2 human immunodeficiency virus infection\n- Renal failure with creatinine clearance less than 30 mL/min\n- Pregnancy and breastfeeding\n- Contraindications to one of the antibiotic\n- Inability to comply with the requirements of the protocol, especially substance abuse, according to the investigator"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary endpoint is the 6-month negative sputum conversion rate.","definition_or_measurement_approach":"Culture results of respiratory specimens taken 6 months after the start of treatment (6-month sputum conversion rate)."}
Secondary endpoints
- {"endpoint_text":"- For safety: digestive toxicity (WHO criteria and Rhodes scale (28, 29)), for hepatitis (cytolysis higher than 3 times normal rate)","definition_or_measurement_approach":"Digestive toxicity assessed using WHO criteria and Rhodes scale; hepatitis defined as cytolysis greater than 3 times the normal rate."}
- {"endpoint_text":"- Clinical improvement on analogic scales","definition_or_measurement_approach":"Clinical improvement measured using analog (visual analog) scales."}
- {"endpoint_text":"- Radiological improvement on CT scan criteria (dimensions of the lesions compared to the baseline CT, classified as complete resolution of the lesions, partial resolution of the lesions: reduction of at least 50% of the lesions, stabilization: size of the lesion between 50% and 130% compared to baseline, deterioration of lesions: appearance of new lesions or greater than 30%","definition_or_measurement_approach":"Radiological assessment by CT scan comparing lesion dimensions to baseline and classifying as complete resolution, partial resolution (≥50% reduction), stabilization (50%–130% of baseline), or deterioration (new lesions or >30% increase)."}
- {"endpoint_text":"- 3 and 12 months sputum conversion (Culture results of respiratory specimens taken 3 and 12 months after starting treatment)","definition_or_measurement_approach":"Culture results of respiratory specimens taken at 3 and 12 months after starting treatment."}
- {"endpoint_text":"- 12 months outcome (death)","definition_or_measurement_approach":"All-cause mortality status at 12 months after treatment start."}
- {"endpoint_text":"- 1 month and 6 months peak serum and mononuclear cells concentration of azithromycin and clarithromycin and their main metabolites (D-azithromycin and 14-OH clarithromycin respectively) determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS)","definition_or_measurement_approach":"Peak serum and intracellular (mononuclear cells) concentrations measured at 1 and 6 months by LC-MS/MS for azithromycin, clarithromycin and main metabolites."}
- {"endpoint_text":"- MAC species and 6-month conversion","definition_or_measurement_approach":"6-month sputum conversion rates stratified by Mycobacterium avium complex species."}
Recruitment
- Planned Sample Size
- 424
- Recruitment Window Months
- 120
- Consent Approach
- Informed consent is obtained from each adult participant (18+). Subject information and informed consent forms are available (documents: L1_SIS Adults, ICF Patients). No procedures for assent or parental consent for minors are described.
Geography
- Total Number Of Sites
- 60
- Total Number Of Participants
- 424
France
- Earliest CTIS Part Ii Submission Date
- 23-10-2024
- Latest Decision Or Authorization Date
- 23-01-2026
- Processing Time Days
- 457
- Number Of Sites
- 60
- Number Of Participants
- 424
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Pneumologie
- Principal Investigator Name
- Sophie BULIFON
- Principal Investigator Email
- sophie.bulifon@aphp.fr
- Contact Person Name
- Sophie BULIFON
- Contact Person Email
- sophie.bulifon@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Bactériologie
- Principal Investigator Name
- Christelle Guillet Caruba
- Principal Investigator Email
- christelle.guillet@aphp.fr
- Contact Person Name
- Christelle Guillet Caruba
- Contact Person Email
- christelle.guillet@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De La Guadeloupe
- Department Name
- Pneumologie
- Principal Investigator Name
- Chantal Raherison Semjen
- Principal Investigator Email
- chantal.raherison@chu-guadeloupe.fr
- Contact Person Name
- Chantal Raherison Semjen
- Contact Person Email
- chantal.raherison@chu-guadeloupe.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Maladies respiratoires
- Principal Investigator Name
- Elodie BLANCHARD
- Principal Investigator Email
- elodie.blanchard@chu-bordeaux.fr
- Contact Person Name
- Elodie BLANCHARD
- Contact Person Email
- elodie.blanchard@chu-bordeaux.fr
- Site Name
- Hopital Saint Joseph
- Department Name
- Pneumologie
- Principal Investigator Name
- Cristina SOCOLOVSCHI AUDOLY
- Principal Investigator Email
- caudoly@hopital-saint-joseph.fr
- Contact Person Name
- Cristina SOCOLOVSCHI AUDOLY
- Contact Person Email
- caudoly@hopital-saint-joseph.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Infectiology
- Principal Investigator Name
- Corine GREIB
- Principal Investigator Email
- carine.greib@chu-bordeaux.fr
- Contact Person Name
- Corine GREIB
- Contact Person Email
- carine.greib@chu-bordeaux.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Pneumologie
- Principal Investigator Name
- Abdellatif TAZI
- Principal Investigator Email
- abdellatif.tazi@aphp.fr
- Contact Person Name
- Abdellatif TAZI
- Contact Person Email
- abdellatif.tazi@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Pneumologie
- Principal Investigator Name
- Diane BOUVRY
- Principal Investigator Email
- diane.bouvry@aphp.fr
- Contact Person Name
- Diane BOUVRY
- Contact Person Email
- diane.bouvry@aphp.fr
- Site Name
- Centre Hospitalier Universitaire Amiens Picardie
- Department Name
- Pneumologie
- Principal Investigator Name
- Claire ANDRJEAK
- Principal Investigator Email
- andrejak.claire@chu-amiens.fr
- Contact Person Name
- Claire ANDRJEAK
- Contact Person Email
- andrejak.claire@chu-amiens.fr
- Site Name
- Centre Hospitalier Universitaire D'Angers
- Department Name
- Pneumologie
- Principal Investigator Name
- Fréderic GAGNADOUX
- Principal Investigator Email
- frgagnadoux@chu-angers.fr
- Contact Person Name
- Fréderic GAGNADOUX
- Contact Person Email
- frgagnadoux@chu-angers.fr
- Site Name
- Centre Hospitalier Le Mans
- Department Name
- Pneumologie
- Principal Investigator Name
- Marie Jouvenot
- Principal Investigator Email
- mjouvenot@ch-lemans.fr
- Contact Person Name
- Marie Jouvenot
- Contact Person Email
- mjouvenot@ch-lemans.fr
- Site Name
- Centre Hospitalier Victor Dupouy
- Department Name
- Pneumologie
- Principal Investigator Name
- Corinne APPERE-DE VECCHI
- Principal Investigator Email
- corinne.appere@ch-argenteuil.fr
- Contact Person Name
- Corinne APPERE-DE VECCHI
- Contact Person Email
- corinne.appere@ch-argenteuil.fr
- Site Name
- Clinique De L'Europe
- Department Name
- Pneumologie
- Principal Investigator Name
- Nicolas BENOIT
- Principal Investigator Email
- nicohelbenoit@gmail.com
- Contact Person Name
- Nicolas BENOIT
- Contact Person Email
- nicohelbenoit@gmail.com
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Pneumologie
- Principal Investigator Name
- François Xavier BLANC
- Principal Investigator Email
- xavier.blanc@chu-nantes.fr
- Contact Person Name
- François Xavier BLANC
- Contact Person Email
- xavier.blanc@chu-nantes.fr
- Site Name
- Centre Hospitalier De Perigueux
- Department Name
- Pneumologie
- Principal Investigator Name
- Claire AGUILAR
- Principal Investigator Email
- claire.aguilar@ch-perigueux.fr
- Contact Person Name
- Claire AGUILAR
- Contact Person Email
- claire.aguilar@ch-perigueux.fr
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- Pneumologie
- Principal Investigator Name
- Sylvain MARCHAND-ADAM
- Principal Investigator Email
- sylvain.marchand-adam@univ-tours.fr
- Contact Person Name
- Sylvain MARCHAND-ADAM
- Contact Person Email
- sylvain.marchand-adam@univ-tours.fr
- Site Name
- Centre Hospitalier Universitaire D Orleans
- Department Name
- Pneumologie
- Principal Investigator Name
- Nafissetou YOBOUET SANFO
- Principal Investigator Email
- nafissetou.sanfo@chr-orleans.fr
- Contact Person Name
- Nafissetou YOBOUET SANFO
- Contact Person Email
- nafissetou.sanfo@chr-orleans.fr
- Site Name
- Centre Hospitalier Departemental Vendee
- Department Name
- Pneumologie
- Principal Investigator Name
- Marie MARCQ
- Principal Investigator Email
- marie.marcq@chd-vendee.fr
- Contact Person Name
- Marie MARCQ
- Contact Person Email
- marie.marcq@chd-vendee.fr
- Site Name
- Groupe Hospitalier Du Sud Ile De France
- Department Name
- Pneumologie
- Principal Investigator Name
- Maxence ROUYER
- Principal Investigator Email
- maxence.rouyer@ghsif.fr
- Contact Person Name
- Maxence ROUYER
- Contact Person Email
- maxence.rouyer@ghsif.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Pneumologie
- Principal Investigator Name
- Alexandra SERRIS
- Principal Investigator Email
- alexandra.serris@aphp.fr
- Contact Person Name
- Alexandra SERRIS
- Contact Person Email
- alexandra.serris@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Pneumologie
- Principal Investigator Name
- Karine RISSO
- Principal Investigator Email
- risso.k@chu-nice.fr
- Contact Person Name
- Karine RISSO
- Contact Person Email
- risso.k@chu-nice.fr
- Site Name
- Centre Hospitalier De Roubaix
- Department Name
- Pneumologie
- Principal Investigator Name
- Nicolas JUST
- Principal Investigator Email
- nicolas.just@ch-roubaix.fr
- Contact Person Name
- Nicolas JUST
- Contact Person Email
- nicolas.just@ch-roubaix.fr
- Site Name
- Centre Hospitalier D'Abbeville
- Department Name
- Pneumologie
- Principal Investigator Name
- Olivier LELEU
- Principal Investigator Email
- leleu.olivier@ch-abbeville.fr
- Contact Person Name
- Olivier LELEU
- Contact Person Email
- leleu.olivier@ch-abbeville.fr
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- Pneumologie
- Principal Investigator Name
- Cécile L'HEVEDER
- Principal Investigator Email
- cecile.lheveder@chu-brest.fr
- Contact Person Name
- Cécile L'HEVEDER
- Contact Person Email
- cecile.lheveder@chu-brest.fr
- Site Name
- Centre Hospitalier De Chauny
- Department Name
- Pneumologie
- Principal Investigator Name
- Hamza Ait Bachir
- Principal Investigator Email
- dr.ait-bachir@ch-chauny.fr
- Contact Person Name
- Hamza Ait Bachir
- Contact Person Email
- dr.ait-bachir@ch-chauny.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Pneumologie
- Principal Investigator Name
- Bruno CRESTANI
- Principal Investigator Email
- bruno.crestani@aphp.fr
- Contact Person Name
- Bruno CRESTANI
- Contact Person Email
- bruno.crestani@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Dijon
- Department Name
- Pneumologie
- Principal Investigator Name
- Philippe BONNIAUD
- Principal Investigator Email
- philippe.bonniaud@chu-dijon.fr
- Contact Person Name
- Philippe BONNIAUD
- Contact Person Email
- philippe.bonniaud@chu-dijon.fr
- Site Name
- Hopital D'Instruction Des Armees Percy
- Department Name
- Pneumologie
- Principal Investigator Name
- Marie-alice CORNETTO
- Principal Investigator Email
- marie-alice.cornetto@intradef.gouv.fr
- Contact Person Name
- Marie-alice CORNETTO
- Contact Person Email
- marie-alice.cornetto@intradef.gouv.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Pneumologie
- Principal Investigator Name
- Romain KESSLER
- Principal Investigator Email
- kesslerl@unistra.fr
- Contact Person Name
- Romain KESSLER
- Contact Person Email
- kesslerl@unistra.fr
- Site Name
- Institut Mutualiste Montsouris
- Department Name
- Pneumologie
- Principal Investigator Name
- Thibault VIEIRA
- Principal Investigator Email
- thibault.vieira@imm.fr
- Contact Person Name
- Thibault VIEIRA
- Contact Person Email
- thibault.vieira@imm.fr
- Site Name
- Centre Hospitalier Universitaire De Saint Etienne
- Department Name
- Pneumologie
- Principal Investigator Name
- Jean-Michel VERGNON
- Principal Investigator Email
- jean.michel.vergnon@univ-st-etienne.fr
- Contact Person Name
- Jean-Michel VERGNON
- Contact Person Email
- jean.michel.vergnon@univ-st-etienne.fr
- Site Name
- Centre Hospitalier Et Universitaire De Limoges
- Department Name
- Pneumologie
- Principal Investigator Name
- Boris MELLONI
- Principal Investigator Email
- boris.melloni@unilim.fr
- Contact Person Name
- Boris MELLONI
- Contact Person Email
- boris.melloni@unilim.fr
- Site Name
- Centre Hospitalier De Versailles
- Department Name
- Pneumologie
- Principal Investigator Name
- Maria Chiara MENNITTI
- Principal Investigator Email
- mcmennitti@ght78sud.fr
- Contact Person Name
- Maria Chiara MENNITTI
- Contact Person Email
- mcmennitti@ght78sud.fr
- Site Name
- Hopital NOVO
- Department Name
- Pneumologie
- Principal Investigator Name
- Marine GOSSET-WOIMANT
- Principal Investigator Email
- marine.gosset-woimant@yahoo.fr
- Contact Person Name
- Marine GOSSET-WOIMANT
- Contact Person Email
- marine.gosset-woimant@yahoo.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Pneumologie
- Principal Investigator Name
- Lucien GUERIN
- Principal Investigator Email
- Lucien.GUERIN@chu-poitiers.fr
- Contact Person Name
- Lucien GUERIN
- Contact Person Email
- Lucien.GUERIN@chu-poitiers.fr
- Site Name
- CHU Besancon
- Department Name
- Pneumologie
- Principal Investigator Name
- Jean-Charles DALPHIN
- Principal Investigator Email
- jean-charles.dalphin@univ-fcomte.fr
- Contact Person Name
- Jean-Charles DALPHIN
- Contact Person Email
- jean-charles.dalphin@univ-fcomte.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Pneumologie
- Principal Investigator Name
- Martine REYNAUD-GAUBERT
- Principal Investigator Email
- MartineLouise.REYNAUD@ap-hm.fr
- Contact Person Name
- Martine REYNAUD-GAUBERT
- Contact Person Email
- MartineLouise.REYNAUD@ap-hm.fr
- Site Name
- Centre Hospitalier Des Pays De Morlaix
- Department Name
- Pneumologie
- Principal Investigator Name
- David RENAULT
- Principal Investigator Email
- drenault@ch-morlaix.fr
- Contact Person Name
- David RENAULT
- Contact Person Email
- drenault@ch-morlaix.fr
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- Pneumologie
- Principal Investigator Name
- Rébecca HAMIDFAR
- Principal Investigator Email
- RHamidfar@chu-grenoble.fr
- Contact Person Name
- Rébecca HAMIDFAR
- Contact Person Email
- RHamidfar@chu-grenoble.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Pneumologie
- Principal Investigator Name
- Jacques CADRANEL
- Principal Investigator Email
- jacques.cadranel@tnn.aphp.fr
- Contact Person Name
- Jacques CADRANEL
- Contact Person Email
- jacques.cadranel@tnn.aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Pneumologie
- Principal Investigator Name
- Pierre Régis BURGEL
- Principal Investigator Email
- pierre-regis.burgel@aphp.fr
- Contact Person Name
- Pierre Régis BURGEL
- Contact Person Email
- pierre-regis.burgel@aphp.fr
- Site Name
- Centre Hospitalier Metropole Savoie
- Department Name
- Pneumologie
- Principal Investigator Name
- Chloé HERREMAN
- Principal Investigator Email
- chloe.herreman@ch-metropole-savoie.fr
- Contact Person Name
- Chloé HERREMAN
- Contact Person Email
- chloe.herreman@ch-metropole-savoie.fr
- Site Name
- Centre Hospitalier Intercommunal Compiegne Noyon
- Department Name
- Pneumologie
- Principal Investigator Name
- Isabelle SIMON
- Principal Investigator Email
- i.simon@ch-compiegnenoyon.fr
- Contact Person Name
- Isabelle SIMON
- Contact Person Email
- i.simon@ch-compiegnenoyon.fr
- Site Name
- Centre Hospitalier De La Cote Basque
- Department Name
- Pneumologie
- Principal Investigator Name
- Marc-Olivier VAREIL
- Principal Investigator Email
- movareil@ch-cotebasque.fr
- Contact Person Name
- Marc-Olivier VAREIL
- Contact Person Email
- movareil@ch-cotebasque.fr
- Site Name
- Centre Hospitalier Intercommunal Creteil
- Department Name
- Pneumologie
- Principal Investigator Name
- Bernard MAITRE
- Principal Investigator Email
- bernard.maitre@chicreteil.fr
- Contact Person Name
- Bernard MAITRE
- Contact Person Email
- bernard.maitre@chicreteil.fr
- Site Name
- Centre Hospitalier Universitaire Reims
- Department Name
- Pneumologie
- Principal Investigator Name
- Gaëtan DESLEE
- Principal Investigator Email
- gdeslee@chu-reims.fr
- Contact Person Name
- Gaëtan DESLEE
- Contact Person Email
- gdeslee@chu-reims.fr
- Site Name
- Centre Hospitalier Universitaire De Caen Normandie
- Department Name
- Pneumologie
- Principal Investigator Name
- Emmanuel BERGOT
- Principal Investigator Email
- bergot-e@chu-caen.fr
- Contact Person Name
- Emmanuel BERGOT
- Contact Person Email
- bergot-e@chu-caen.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Pneumologie
- Principal Investigator Name
- Marlène MURRIS ESPIN
- Principal Investigator Email
- murris.m@chu-toulouse.fr
- Contact Person Name
- Marlène MURRIS ESPIN
- Contact Person Email
- murris.m@chu-toulouse.fr
- Site Name
- Centre Hospitalier De Saint-Quentin
- Department Name
- Pneumologie
- Principal Investigator Name
- Hamza DOUADI
- Principal Investigator Email
- y.douadi@ch-stquentin.fr
- Contact Person Name
- Hamza DOUADI
- Contact Person Email
- y.douadi@ch-stquentin.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Pneumologie
- Principal Investigator Name
- Arnaud BOURDIN
- Principal Investigator Email
- arnaud01009157@gmail.com
- Contact Person Name
- Arnaud BOURDIN
- Contact Person Email
- arnaud01009157@gmail.com
- Site Name
- Centre Hospitalier Simone Veil De Beauvais
- Department Name
- Pneumologie
- Principal Investigator Name
- Sabrina LENEL
- Principal Investigator Email
- rechercheclinique@ch-beauvais.fr
- Contact Person Name
- Sabrina LENEL
- Contact Person Email
- rechercheclinique@ch-beauvais.fr
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- Pneumologie
- Principal Investigator Name
- Mallorie KERJOUAN
- Principal Investigator Email
- Mallorie.KERJOUAN@chu-rennes.fr
- Contact Person Name
- Mallorie KERJOUAN
- Contact Person Email
- Mallorie.KERJOUAN@chu-rennes.fr
- Site Name
- Centre Hospitalier Annecy Genevois
- Department Name
- Pneumologie
- Principal Investigator Name
- Gabriel MACHEDA
- Principal Investigator Email
- gmacheda@ch-annecygenevois.fr
- Contact Person Name
- Gabriel MACHEDA
- Contact Person Email
- gmacheda@ch-annecygenevois.fr
- Site Name
- Centre Hospitalier Universitaire Rouen
- Department Name
- Pneumologie
- Principal Investigator Name
- Hélène MORISSE PRADIER
- Principal Investigator Email
- helene.morisse@chu-rouen.fr
- Contact Person Name
- Hélène MORISSE PRADIER
- Contact Person Email
- helene.morisse@chu-rouen.fr
- Site Name
- Hospital Foch
- Department Name
- Pneumologie
- Principal Investigator Name
- Emilie CATHERINOT
- Principal Investigator Email
- e.catherinot@hopital-foch.org
- Contact Person Name
- Emilie CATHERINOT
- Contact Person Email
- e.catherinot@hopital-foch.org
- Site Name
- Centre Hospitalier De Cannes Simone Veil
- Department Name
- Pneumologie
- Principal Investigator Name
- Florence LE MEUNIER
- Principal Investigator Email
- florence.le.meunier@gmail.com
- Contact Person Name
- Florence LE MEUNIER
- Contact Person Email
- florence.le.meunier@gmail.com
- Site Name
- CHRU De Nancy
- Department Name
- Pneumologie
- Principal Investigator Name
- Jean-François CHABOT
- Principal Investigator Email
- f.chabot@chu-nancy.fr
- Contact Person Name
- Jean-François CHABOT
- Contact Person Email
- f.chabot@chu-nancy.fr
- Site Name
- Centre Hospitalier Universitaire De Lyon (Hospices Civils De Lyon)
- Department Name
- Pneumologie
- Principal Investigator Name
- Gilles DEVOUASSOUX
- Principal Investigator Email
- gilles.devouassoux@chu-lyon.fr
- Contact Person Name
- Gilles DEVOUASSOUX
- Contact Person Email
- gilles.devouassoux@chu-lyon.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Pneumologie
- Principal Investigator Name
- Nicolas VEZIRIS
- Principal Investigator Email
- nicolas.veziris@sorbonne-universite.fr
- Contact Person Name
- Nicolas VEZIRIS
- Contact Person Email
- nicolas.veziris@sorbonne-universite.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Pneumologie
- Principal Investigator Name
- Jean-François BERVAR
- Principal Investigator Email
- Jean-Francois.BERVAR@CHRU-LILLE.FR
- Contact Person Name
- Jean-François BERVAR
- Contact Person Email
- Jean-Francois.BERVAR@CHRU-LILLE.FR
Sponsor
Primary sponsor
- Full Name
- Centre Hospitalier Universitaire Amiens Picardie
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- RIFADINE 300 mg, gélule
- Active Substance
- RIFAMPICIN
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Authorisation Status
- 34009 309 150 0 4
- Maximum Dose
- 10 mg/kg
- Investigational Product Name
- CLARITHROMYCINE ARROW 500 mg, comprimé pelliculé à libération modifiée
- Active Substance
- CLARITHROMYCIN
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Authorisation Status
- 60726518
- Maximum Dose
- 1000 mg
- Investigational Product Name
- DEXAMBUTOL 500 mg, comprimé pelliculé
- Active Substance
- ETHAMBUTOL HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Authorisation Status
- 34009 311 621-7 9
- Maximum Dose
- 20 mg/kg
- Investigational Product Name
- AZITHROMYCINE TEVA 250 mg, comprimé pelliculé
- Active Substance
- AZITHROMYCIN
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Authorisation Status
- NL31563
- Maximum Dose
- 250 mg
- Combination Treatment
- Yes
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