Tigecycline for Treatment of Rapidly Growing Mycobacteria

NCT ID: NCT00600600

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2010-12-31

Brief Summary

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

Detailed Description

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

Conditions

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Mycobacterium Abscessus Lung Disease Rapidly Growing Mycobacterial Lung Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tigecycline

tigecycline titrated dose according to patient age and clinical status

Group Type EXPERIMENTAL

Tigecycline

Intervention Type DRUG

Tigecycline dosage based on age and clinical status of patient.

Interventions

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Tigecycline

Tigecycline dosage based on age and clinical status of patient.

Intervention Type DRUG

Other Intervention Names

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tygacil

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role collaborator

The University of Texas Health Science Center at Tyler

OTHER

Sponsor Role lead

Responsible Party

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

Chairman Department of Microbiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard J Wallace Jr., M.D.

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at Tyler

Locations

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The University of Texas Health Science Center at Tyler

Tyler, Texas, United States

Site Status

Countries

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United States

References

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Wallace RJ Jr, Dukart G, Brown-Elliott BA, Griffith DE, Scerpella EG, Marshall B. Clinical experience in 52 patients with tigecycline-containing regimens for salvage treatment of Mycobacterium abscessus and Mycobacterium chelonae infections. J Antimicrob Chemother. 2014 Jul;69(7):1945-53. doi: 10.1093/jac/dku062. Epub 2014 Mar 14.

Reference Type DERIVED
PMID: 24633206 (View on PubMed)

Other Identifiers

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660

Identifier Type: -

Identifier Source: org_study_id

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