NCT03164291

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 1984

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1984

Completed
22.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2008

Completed
9.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 23, 2017

Completed
Last Updated

May 23, 2017

Status Verified

May 1, 2017

Enrollment Period

22.3 years

First QC Date

January 14, 2008

Last Update Submit

May 19, 2017

Conditions

Nontuberculous Mycobacterial Infections

Keywords

MAC and NTM

Outcome Measures

Primary Outcomes (1)

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

    neg cultures X3( sputum conversion)

    6 mos

Secondary Outcomes (1)

  • Microbiological Cultures

    1year

Study Arms (1)

Rifabutin

EXPERIMENTAL

Treatment of adults with chronic Mycobacterium avium-intracellulare complex lung infections or other NTM disease who fail therapy with other drugs ( i.e., rifampin)

Drug: Rifabutin

Interventions

RifabutinDRUG

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

Also known as: mycobutin
Rifabutin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Children less than 18 years of age
  • Pregnancy
  • Low platelet count, except with very serious disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Tyler

Tyler, Texas, 75708, United States

Location

MeSH Terms

Conditions

Mycobacterium avium-intracellulare Infection

Interventions

Rifabutin

Condition Hierarchy (Ancestors)

Mycobacterium Infections, NontuberculousMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

RifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Richard J Wallace, Jr, M.D.

    The University of Texas Health Center at Tyler

    PRINCIPAL INVESTIGATOR

  • William B Girard, MD

    University of Texas Health Science Center IRB Chair

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman Department of Microbiology

Study Record Dates

First Submitted

January 14, 2008

First Posted

May 23, 2017

Study Start

June 1, 1984

Primary Completion

September 1, 2006

Study Completion

May 18, 2017

Last Updated

May 23, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)