Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-26 @ 11:41 AM
Study NCT ID:
NCT01973192
Status:
COMPLETED
Last Update Posted:
2017-04-04
First Post:
2013-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Viral Pathogenesis of Early Cystic Fibrosis Lung Disease
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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood Urea, Bronchopulmonary Lavage samples, Nasal swabs and Oral swabs, Stool samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-03', 'studyFirstSubmitDate': '2013-09-17', 'studyFirstSubmitQcDate': '2013-10-25', 'lastUpdatePostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Bronchiectasis', 'timeFrame': '12 Months', 'description': 'To evaluate the association of early viruses on the development of early lung disease in CF infants as defined through comprehensive structural and airway modeling techniques.'}], 'primaryOutcomes': [{'measure': 'Viral infection', 'timeFrame': '12 months', 'description': 'To determine the effect(s) of viral infections on the evolution of endobronchial bacterial infection and inflammation in CF infants.'}], 'secondaryOutcomes': [{'measure': 'Pulmonary exacerbation rate', 'timeFrame': '12 Months', 'description': 'To identify the impact of respiratory viruses on the onset, frequency, and duration of respiratory symptoms in CF infants diagnosed through newborn screening.'}, {'measure': 'Forced Expiratory Volume', 'timeFrame': '12 months', 'description': 'To assess development of early lung disease as defined through physiological measures of forced expiratory flows, lung volumes, and ventilation inhomogeneity in CF infants.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the hypothesis that early viral infections alter the bacterial flora and inflammatory profile in the airway and accelerate progression of pulmonary disease in infants with cystic fibrosis.', 'detailedDescription': 'The proposed study is a unique international collaboration between three large CF research centers. This proposal will determine the impact of early respiratory viral infections on bacterial flora and inflammatory profiles in the CF airway as well as the impact of these pathogens on clinical, physiologic and structural markers of disease.The proposed study is designed to follow infants diagnosed with CF through newborn screening to determine the effect of viral infections on the lower airway microbiome, clinical symptoms, pulmonary function and structural changes during the first year of life. The proposed study will measure lower airway inflammation and infection using BAL, oral swabs, and nasal swabs; outcomes will be assessed through infant lung function testing, computerized tomography scans of the chest, and pulmonary exacerbation rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Months', 'minimumAge': '2 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Infants, less than 4 months of age who have been diagnosed with Cystic Fibrosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of CF by newborn screening, at least one clinical feature of CF, and documented sweat chloride greater than 60 mEq/L by quantitative pilocarpine iontophoresis or compatible genotype with two identifiable mutant CFTR alleles.\n2. Less than 4 months of age at Screening Visit\n3. Ability to comply with study visits and study procedures as judged by site investigator.\n\nExclusion Criteria:\n\n1. Intercurrent respiratory illness, defined as increase in cough, wheezing, or respiratory rate with onset 14 days before iPFT-bronchoscopy visit.\n2. Measured hemoglobin oxygen saturation less than 95% during the iPFT-bronchoscopy visit.\n3. History of adverse reaction to sedation.\n4. Clinically significant upper airway obstruction as determined by the site investigator.\n5. Severe gastroesophageal reflux, defined as persistent frequent emesis despite therapy.\n6. Major organ dysfunction, not including pancreatic dysfunction.\n7. Physical findings that would compromise the safety of the subject or the quality of the study data as determined by site investigator.'}, 'identificationModule': {'nctId': 'NCT01973192', 'acronym': 'Early CF', 'briefTitle': 'Viral Pathogenesis of Early Cystic Fibrosis Lung Disease', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Viral Pathogenesis of Early Cystic Fibrosis Lung Disease', 'orgStudyIdInfo': {'id': '1R01HL116211-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01HL116211-01', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '1R01HL116211-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01HL116211-01', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Riley Hospital for Children at Indiana University Health', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "St. Louis Children's Hospital", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': "The Royal Children's Hospital", 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '6872', 'city': 'West Perth', 'country': 'Australia', 'facility': 'Telethon Kids Institute', 'geoPoint': {'lat': -31.94896, 'lon': 115.84199}}], 'overallOfficials': [{'name': 'Stephanie D. Davis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Section Director of Pediatric Pulmonology, Allergy and Sleep Medicine', 'investigatorFullName': 'Stephanie D. Davis', 'investigatorAffiliation': 'Indiana University'}}}}