Effectiveness of Rifabutin in the Treatment of Mycobacterium Avium Complex

NCT03164291

Last updated date
Study Location
The University of Texas Health Science Center at Tyler
Tyler, Texas, 75708, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Nontuberculous Mycobacterial Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Adults age 18 and older with positive acid-fast bacilli smears and cultures for drug-resistant mycobacteria

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Children less than 18 years of age


- Pregnancy


- Low platelet count, except with very serious disease

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Nontuberculous Mycobacterial InfectionsEffectiveness of Rifabutin in the Treatment of Mycobacterium Avium Complex
NCT03164291
  1. Tyler, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Effectiveness of Rifabutin in the Treatment of Mycobacterium Avium Complex
Official Title  ICMJE Clinical Efficacy of Rifabutin in the Treatment of Serious and Life Threatening Infections Due to Mycobacterium Avium Complex, or Drug Resistant Mycobacterium Tuberculosis, or Other Drug Resistant Mycobacterium
Brief Summary

Treatment of adults with chronic Mycobacterium avium-intracellulare complex lung infections who have failed or are intolerant of rifampin.

Rifabutin may be a reasonable alternative agent in patients who fail rifampin or or intolerant of rifampin.

Detailed Description Rifabutin dosage 150-300 mg daily( depending upon age, and clinical conditions) in NTM patients who fail treatment with rifampin.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Nontuberculous Mycobacterial Infections
Intervention  ICMJE Drug: Rifabutin
Rifabutin dosage dependent on clinical factors such as age, weight, and patient-specific health status
Other Name: mycobutin
Study Arms  ICMJE Experimental: Rifabutin
Treatment of adults with chronic Mycobacterium avium-intracellulare complex lung infections or other NTM disease who fail therapy with other drugs ( i.e., rifampin)
Intervention: Drug: Rifabutin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 19, 2017)
170
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 18, 2017
Actual Primary Completion Date September 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults age 18 and older with positive acid-fast bacilli smears and cultures for drug-resistant mycobacteria

Exclusion Criteria:

  • Children less than 18 years of age
  • Pregnancy
  • Low platelet count, except with very serious disease
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03164291
Other Study ID Numbers  ICMJE 072
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Richard J. Wallace, Jr., M.D., The University of Texas Health Science Center at Tyler
Study Sponsor  ICMJE The University of Texas Health Science Center at Tyler
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Richard J Wallace, Jr, M.D.The University of Texas Health Center at Tyler
Study Chair:William B Girard, MDUniversity of Texas Health Science Center IRB Chair
PRS Account The University of Texas Health Science Center at Tyler
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP