Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004296
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-10-18
Brief Title:
Multicenter Study of Nontuberculous Mycobacteria in Cystic Fibrosis Patients
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES I Determine the prevalence of nontuberculous mycobacteria in sputum cultures from patients with cystic fibrosis
II Compare the clinical course of patients with negative versus positive cultures
II Compare the clinical course of patients with negative versus positive cultures
Detailed Description:
PROTOCOL OUTLINE Participants are screened for nontuberculous mycobacteria NTM with 3 sputum acid-fast bacilli smears and mycobacterial cultures with speciation of positive cultures collected over 1 year Demographic data diagnostic criteria clinical measurements and other respiratory pathogen data are collected using the Cystic Fibrosis Foundation Patient Registry Questionnaire
NTM-positive patients cases matched with NTM-negative controls identified in screening are followed every 3 months for 15 months Cases are evaluated for NTM burden during the first 3 months
Appropriate therapy is offered to consistently NTM-positive cases Lung transplant recipients are removed from study
NTM-positive patients cases matched with NTM-negative controls identified in screening are followed every 3 months for 15 months Cases are evaluated for NTM burden during the first 3 months
Appropriate therapy is offered to consistently NTM-positive cases Lung transplant recipients are removed from study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UNCCH-939 | None | None | None |