NCT02198079

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 23, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

May 25, 2015

Status Verified

May 1, 2015

Enrollment Period

5 years

First QC Date

February 21, 2014

Last Update Submit

May 22, 2015

Conditions

Cystic FibrosisPediatrics

Keywords

non-tuberculous mycobacteriaPediatricsCystic Fibrosis

Outcome Measures

Primary Outcomes (1)

  • Positive culture for non-tuberculous mycobacteria (NTM)

    Sputum or bronchoalveolar lavage sample will be analyzed for culture of NTM

    At visit one

Secondary Outcomes (1)

  • Prevalence of NTM

    Week 52

Study Arms (1)

Cystic Fibrosis

Children with Cystic Fibrosis

Biological: Sputum

Interventions

SputumBIOLOGICAL
Cystic Fibrosis

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with Cystic Fibrosis aged from 0 to 18 years.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami, Miller School of Medicine

Miami, Florida, 33136, United States

Location

Biospecimen

Retention: NONE RETAINED

one sputum, throat, or bronchoalveolar lavage

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Andrew Colin, MD, SM

    University of Miami

    PRINCIPAL INVESTIGATOR

  • Shatha Yousef, MD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

February 21, 2014

First Posted

July 23, 2014

Study Start

March 1, 2010

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

May 25, 2015

Record last verified: 2015-05

Locations

US(1)