Zitromax (DrugBank: -)
2 diseases| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 228 | Bronchiolitis obliterans | 2 |
| 299 | Cystic fibrosis | 3 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2012-003331-32-BE (EUCTR) | 18/06/2013 | 12/11/2012 | A PROSPECTIVE, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF PRE-TRANSPLANT AND PROMPT POST-TRANSPLANT TREATMENT WITH AZITHROMYCIN TO IMPROVE EARLY ALLOGRAFT FUNCTION AND OUTCOME AFTER LUNG TRANSPLANTATION | A PROSPECTIVE, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF PRE-TRANSPLANT AND PROMPT POST-TRANSPLANT TREATMENT WITH AZITHROMYCIN TO IMPROVE EARLY ALLOGRAFT FUNCTION AND OUTCOME AFTER LUNG TRANSPLANTATION | EARLY LUNG ALLOGRAFT FUNCTION AND OUTCOME AFTER LUNG TRANSPLANTATION MedDRA version: 14.1;Level: LLT;Classification code 10050437;Term: Prophylaxis against heart and lung transplant rejection;System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1;Classification code 10016547;Term: FEV;System Organ Class: 10022891 - Investigations MedDRA version: 14.1;Classification code 10050433;Term: Prophylaxis against lung transplant rejection;Classification code 10006414;Term: Bronchial biopsy abnormal;Classification code 10025041;Term: Lung biopsy abnormal;Classification code 10016549;Term: FEV 1 abnormal;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Level: PT;Classification code 10025127;Term: Lung transplant;Classification code 10049237;Term: Acute cellular rejection;System Organ Class: 10021428 - Immune system disorders MedDRA version: 14.1;Classification code 10066543;Term: Acute allograft rejection;Classification code 10039008;Term: Reversible airways obstruction NOS;Classification code 10019319;Term: Heart-lung transplant rejection;Level: LLTClassi;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Azithromycin (Zitromax°) Product Name: Zitromax Product Code: not applicable INN or Proposed INN: AZITHROMYCIN Other descriptive name: AZITHROMYCIN | KULeuven and University Hospitals Leuven | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 4 | Belgium | ||
| 2 | EUCTR2010-018724-16-BE (EUCTR) | 15/04/2010 | 07/04/2010 | A prospective, open-label, pilot-study of azithromycin for lymphocytic bronchi(oli)tis after lung transplantation - Azithromycin in lymphocytic bronchi(oli)tis | A prospective, open-label, pilot-study of azithromycin for lymphocytic bronchi(oli)tis after lung transplantation - Azithromycin in lymphocytic bronchi(oli)tis | Lymphocytic airway inflammation (so-called Lymphocytic Bronchitis or Bronchiolitis) post-lung transplantation: evolution of airway inflammation (BAL, TBB), pulmonary function, radiology after 3 months, 6 months, 12 months and outcome 2 years (mortality, bronchiolitis obliterans syndrome) after treatment for histologic confirmed lymphocytic bronchi(oli)tis without concurrent acute allograft rejection. MedDRA version: 12.1;Level: LLT;Classification code 10006414;Term: Bronchial biopsy abnormal MedDRA version: 12.1;Classification code 10025041;Term: Lung biopsy abnormal MedDRA version: 12.1;Classification code 10063078;Term: Bronchoalveolar lavage abnormal MedDRA version: 12.1;Classification code 10049083;Term: Respiratory tract infection NOS MedDRA version: 12.1;Classification code 10016547;Term: FEV MedDRA version: 12.1;Classification code 10016549;Term: FEV 1 abnormal MedDRA version: 12.1;Classification code 10016550;Term: FEV 1 decreased MedDRA version: 12.1;Classification code 10016553;Term: FEV 1 low MedDRA version: 12.1;Classification code 10057799;Term: Computerised tomogram thorax abnormal MedDRA version: 12.1;Classification code 10025127;Term: Lung transplant MedDRA version: 12.1;Classification code 10056409;Term: Heart and lung transplant MedDRA version: 12.1;Classification code 10051604;Term: Lung transplant rejection MedDRA version: 12.1;Classification code 10019319;Term: Heart-lung transplant rejection MedDRA version: 12.1;Classification code 10029888;Term: Obliterative bronchiolitis MedDRA version: 12.1;Classification code 10049202;Term: Bronchiolitis obliterans MedDRA version: 12.1;Classification code 10050433;Term: Prophylaxis against lung transplant rejection MedDRA version: 12.1;Level: LLTClassification c | Trade Name: Zitromax Product Name: Zitromax Product Code: Na INN or Proposed INN: OTHER SOURCES Other descriptive name: AZITHROMYCIN DIHYDRATE | KULeuven and University Hospitals Leuven (Leuven Lung Transplant Group) | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 4 | Belgium |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2006-003275-12-NO (EUCTR) | 03/06/2009 | 27/03/2009 | Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study | Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study | Cystic fibrosis with intermittent colonization of the airways with pseudomonas aeruginosa. MedDRA version: 8.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung | Trade Name: Zitromax Product Name: Zitromax Product Code: Zitromax INN or Proposed INN: AZITHROMYCIN Trade Name: Zitromax Product Name: zitromax Product Code: zitromax INN or Proposed INN: AZITHROMYCIN | Copenhagen CF-centre | NULL | NA | Female: yes Male: yes | 250 | Phase 4 | Denmark;Norway;Sweden | ||
| 2 | EUCTR2006-003275-12-DK (EUCTR) | 23/05/2007 | 17/04/2007 | Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study | Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study | Cystic fibrosis with intermittent colonization of the airways with pseudomonas aeruginosa. MedDRA version: 8.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung | Trade Name: Zitromax Product Name: zitromax Product Code: zitromax INN or Proposed INN: AZITHROMYCIN Trade Name: Zitromax Product Name: zitromax Product Code: zitromax INN or Proposed INN: AZITHROMYCIN | Copenhagen CF-centre | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 4 | Denmark | ||
| 3 | EUCTR2006-003275-12-SE (EUCTR) | 07/07/2009 | Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study | Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study | Cystic fibrosis with intermittent colonization of the airways with pseudomonas aeruginosa. MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders | Trade Name: Azithromycin Product Name: azithromycin Product Code: azithromycin INN or Proposed INN: AZITHROMYCIN Trade Name: Zitromax Product Name: zitromax Product Code: zitromax INN or Proposed INN: AZITHROMYCIN | Copenhagen CF-centre | NULL | NA | Female: yes Male: yes | 250 | Phase 4 | Denmark;Norway;Sweden |