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OpenTrials
Completed

NCT Number: NCT03164291

Effectiveness of Rifabutin in the Treatment of Mycobacterium Avium Complex

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.

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Key information

Conditions

Nontuberculous Mycobacterial Infections Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections Mycobacterium Infections, Nontuberculous Mycobacterium avium-intracellulare Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The University of Texas Health Science Center at Tyler

Tyler, Texas, 75708, United States

About this study

Rifabutin dosage 150-300 mg daily( depending upon age, and clinical conditions) in NTM patients who fail treatment with rifampin.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rifabutin

Drug

Rifabutin dosage dependent on clinical factors such as age, weight, and patient-specific health status

Other names: mycobutin

Primary outcomes

  1. Clinical and microbiological outcomes (e.g. clinical symptoms, laboratory cultures)

    Time frame: 6 mos

    neg cultures X3( sputum conversion)

Secondary outcomes

  1. Microbiological Cultures

    Time frame: 1year

    neg cultures for 1 yr on treatment

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at Tyler

Other

Collaborators

  • Pfizer

Registry information

Official study title

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

Important dates

Study start
1984
Primary completion
2006
Study completion
2017
First posted
May 23, 2017
Registry last updated
May 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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