Tigecycline for Treatment of Rapidly Growing Mycobacteria

May 19, 2017 updated by: Richard J. Wallace, Jr., M.D., The University of Texas Health Science Center at Tyler

Use of Tigecycline for Treatment of Serious Infection Due to Rapidly Growing Mycobacteria (Especially M.Abscessus)

To determine the safety, tolerance, and efficacy of Tigecycline when given daily to patients with rapidly growing mycobacterial disease (especially M.abscessus).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To assess the safety and efficacy of tigecycline in the treatment of drug resistant rapidly growing mycobacterial disease especially M. abscessus

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Tyler, Texas, United States, 75708
        • The University of Texas Health Science Center at Tyler

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Positive cultures for rapidly growing mycobacteria
  • Patients who have drug resistant isolates or are intolerant of macrolides or have serious infections unresponsive to currently available drugs
  • Adults and children 10 years of age and older
  • Pretreatment isolate of M. avium complex available for MIC determination
  • Available for followup appointments

Exclusion Criteria:

  • History of tetracycline allergy
  • If a menstruating female, not pregnant and on adequate birth control

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tigecycline
tigecycline titrated dose according to patient age and clinical status
Drug: Tigecycline
Tigecycline dosage based on age and clinical status of patient.
Other Names:
  • tygacil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures
Time Frame: 6 mos
culture neg X3 ( sputum conversion)
6 mos

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical and Microbiological outcomes
Time Frame: 6 mos
clinical and radiographic improvements
6 mos

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at Tyler

Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

January 14, 2008

First Submitted That Met QC Criteria

January 14, 2008

First Posted (Estimate)

January 25, 2008

Study Record Updates

Last Update Posted (Actual)

May 23, 2017

Last Update Submitted That Met QC Criteria

May 19, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 660

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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