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Improving Treatment of Nontuberculous Mycobacterial Infection in Cystic Fibrosis

NCT02372383 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2021-02-11

Study results available
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Summary

The purpose of this study is to determine antimycobacterial drug pharmacokinetics (PK) and pharmacodynamics (PD) in patients with cystic fibrosis (CF) to improve treatment of nontuberculous mycobacterial (NTM) lung disease.

Conditions

Interventions

DRUG

Ethambutol

Anti-mycobacterial oral drug

DRUG

Rifampin

Anti-mycobacterial oral drug

DRUG

Azithromycin

Anti-mycobacterial oral drug

DRUG

Pancrelipase

Pancreatic enzyme replacement therapy

Sponsors & Collaborators

  • Cystic Fibrosis Foundation

    collaborator OTHER

  • Colorado Clinical & Translational Sciences Institute

    collaborator OTHER

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Stacey Martiniano, MD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
16 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02372383 on ClinicalTrials.gov