Effectiveness of Rifabutin in the Treatment of Mycobacterium Avium Complex

NCT ID: NCT03164291

Last Updated: 2017-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

1984-06-30

Study Completion Date

2017-05-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nontuberculous Mycobacterial Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

Group Type EXPERIMENTAL

Rifabutin

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rifabutin

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

mycobutin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role collaborator

The University of Texas Health Science Center at Tyler

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Richard J. Wallace, Jr., M.D.

Chairman Department of Microbiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Richard J Wallace, Jr, M.D.

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Center at Tyler

William B Girard, MD

Role: STUDY_CHAIR

University of Texas Health Science Center IRB Chair

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The University of Texas Health Science Center at Tyler

Tyler, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

072

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Shorter and Safer Treatment Regimens for Latent TB
NCT06498414 NOT_YET_RECRUITING PHASE2/PHASE3
Phase 2a Study of PBTZ169
NCT03334734 TERMINATED PHASE2