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A Prospective, Multicenter, Collaborative Study to Determine the Prevalence of Nontuberculous Mycobacteria (NTM) in Pediatric Patients With Cystic Fibrosis in Florida

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ClinicalTrials.gov Identifier: NCT02198079
Recruitment Status : Completed
First Posted : July 23, 2014
Last Update Posted : May 25, 2015
Sponsor:
Collaborator:
University of Florida
Information provided by (Responsible Party):
Andrew Colin, University of Miami

Brief Summary:
To determine the prevalence of nontuberculous mycobacterial infection (NTM) in pediatric patients with cystic fibrosis in the State fo Florida. HYPOTHESIS: There is high prevalence of NTM in CF pediatric population in the State of Florida, and likely higher than in the rest of the country.

Condition or disease Intervention/treatment
Cystic Fibrosis Pediatrics Biological: Sputum

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 85 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective, Multicenter, Collaborative Study to Determine the Prevalence of Nontuberculous Mycobacteria (NTM) in Pediatric Patients With Cystic Fibrosis in Florida
Study Start Date : March 2010
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015


Group/Cohort Intervention/treatment
Cystic Fibrosis
Children with Cystic Fibrosis
Biological: Sputum



Primary Outcome Measures :
  1. Positive culture for non-tuberculous mycobacteria (NTM) [ Time Frame: At visit one ]
    Sputum or bronchoalveolar lavage sample will be analyzed for culture of NTM


Secondary Outcome Measures :
  1. Prevalence of NTM [ Time Frame: Week 52 ]
    The prevalence of the NTM found in the cultures will be determined from this sample


Biospecimen Retention:   None Retained
one sputum, throat, or bronchoalveolar lavage


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Cystic Fibrosis aged from 0 to 18 years.
Criteria

Inclusion Criteria:

  • Patients that have a diagnosis of Cystic Fibrosis and are 18 or below years of age

Exclusion Criteria:

  • Patients that are above 18 years of age and or patients that do not have the diagnosis of Cystic fibrosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02198079


Locations
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United States, Florida
University of Miami, Miller School of Medicine
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
University of Florida
Investigators
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Principal Investigator: Andrew Colin, MD, SM University of Miami
Principal Investigator: Shatha Yousef, MD University of Miami

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Responsible Party: Andrew Colin, Professor of Pediatrics, University of Miami
ClinicalTrials.gov Identifier: NCT02198079     History of Changes
Other Study ID Numbers: 20090499
First Posted: July 23, 2014    Key Record Dates
Last Update Posted: May 25, 2015
Last Verified: May 2015
Keywords provided by Andrew Colin, University of Miami:
non-tuberculous mycobacteria
Pediatrics
Cystic Fibrosis
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Mycobacterium Infections
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections