Ignite Creation Date:
2025-12-24 @ 4:09 PM
Ignite Modification Date:
2025-12-25 @ 2:09 PM
Study NCT ID:
NCT03421366
Status:
UNKNOWN
Last Update Posted:
2020-10-26
First Post:
2017-12-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Modified Release Posaconazole in Patients With Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C101425', 'term': 'posaconazole'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'As standard of care a pre-treatment sputum is collected for fungal cultures. The Aspergillus isolates collected will be retained and stored frozen for future testing of posaconazole susceptibility and whole genome sequencing to characterize clonal types and virulence properties'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-02-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-22', 'studyFirstSubmitDate': '2017-12-27', 'studyFirstSubmitQcDate': '2018-01-29', 'lastUpdatePostDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum levels of posaconazole in patients with cystic fibrosis taking the newer modified release once daily oral formulation.', 'timeFrame': '7 days', 'description': 'Posaconazole serum levels at days 2, 5 and 7'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['posaconazole'], 'conditions': ['Cystic Fibrosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://link.springer.com/article/10.2165/00003088-199835040-00004', 'label': 'Rey E, Treluyer J, Pons G. Drug Dispostion in Cysytic Fibrosis. Clin Pharmacokinet 1998 Oct; 35 (4): 313-329'}]}, 'descriptionModule': {'briefSummary': 'A prospective single center observational cohort of patients with cystic fibrosis to determine whether adequate serum levels of posaconazole, after administration of the newer modified release once daily oral formulation, can be achieved.', 'detailedDescription': 'Use of antifungals has increased in people with cystic fibrosis. Aspergillus is the dominant fungal pathogen in this patient population and thus far, voriconazole has been used first line. Apart from recurrent and chronic lung infections, people with cystic fibrosis can also have problems with their gastrointestinal tract and absorption, and can develop chronic liver disease. As a consequence, they are at high-risk for not achieving adequate antifungal levels, which may be due to altered oral bioavailability, and they may be more susceptible to hepatic toxicities.\n\nThis study will evaluate the use of the newer modified release, once daily formulation of posaconazole in people with cystic fibrosis to identify if there is any difference in the bioavailability of the drug due to the effect of cystic fibrosis on the gastrointestinal tract. This newer formulation of once daily posaconazole is approved by the Therapeutic Goods Administration (TGA) and available on the Pharmaceutical Benefits Scheme (PBS) since March 2015. The newer formulation has the potential to overcome one of the major challenges with antifungals in cystic fibrosis; oral bioavailability. Posaconazole also appears to have reduced hepatotoxicity. This study will focus on the safety and tolerability of the drug, as well as pharmacological and microbiological endpoints.\n\n20 eligible participants will be enrolled and have a\n\n* Pre-treatment sputum will be collected as standard of care.\n* Posaconazole serum levels will be taken at days 2, 5 and 7. (Day 5 and 7 as standard of care).\n* renal and liver function assessed whilst on treatment as standard of care.\n* followed up for 30 days to assess tolerability and monitor for the development of liver toxicity'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with cystic fibrosis attending care at the Alfred Hospital in Melbourne Australia', 'healthyVolunteers': False, 'eligibilityCriteria': '* Albe to provide written informed consent\n* Greater than 18 years of age or older\n* Have a diagnosis of cystic fibrosis\n* To commence as part of their standard of care the newer modified release oral formulation of posaconazole to treat Aspergillus\n* Able to provide a pre-treatment sputum collected for fungal culture as part of standard of care\n* Have been prescribed a loading dose of 300mg bd for 1 day of the modified release posaconazole tablet followed by 300mg daily.\n\nExclusion Criteria:\n\n* • Known azole hypersensitivity'}, 'identificationModule': {'nctId': 'NCT03421366', 'briefTitle': 'Modified Release Posaconazole in Patients With Cystic Fibrosis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bayside Health'}, 'officialTitle': 'Modified Release Posaconazole in Patients With Cystic Fibrosis', 'orgStudyIdInfo': {'id': '432.17'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cystic Fibrosis on Posaconazole', 'description': '* Able to provide written informed consent\n* Greater than 18 years of age or older\n* Have a diagnosis of cystic fibrosis\n* No known azole hypersensitivity\n* To commence as part of their standard of care the newer modified release oral formulation of posaconazole to treat Aspergillus\n* Able to provide a pre-treatment sputum collected for fungal culture as part of standard of care\n* Have been prescribed a loading dose of 300mg bd for 1 day of the modified release posaconazole tablet followed by 300mg daily.', 'interventionNames': ['Drug: Posaconazole']}], 'interventions': [{'name': 'Posaconazole', 'type': 'DRUG', 'description': 'A triazole antifungal drug that is used to treat invasive infections by Candida species and Aspergillus species in severely immunocompromised patients', 'armGroupLabels': ['Cystic Fibrosis on Posaconazole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Janine Roney', 'role': 'CONTACT', 'email': 'j.roney@alfred.org.au', 'phone': '+61390762296'}, {'name': 'A Peleg, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'centralContacts': [{'name': 'Janine Roney, BHSc RN MPH', 'role': 'CONTACT', 'email': 'j.roney@alfred.org.au', 'phone': '+61390762296'}, {'name': 'Anton Peleg, MBBS FRACP PhD', 'role': 'CONTACT', 'email': 'anton.peleg@monash.edu', 'phone': '+61390763009'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayside Health', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}