Tigecycline for Treatment of Rapidly Growing Mycobacteria

NCT00600600

Last updated date
Study Location
The University of Texas Health Science Center at Tyler
Tyler, Texas, 75708, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Mycobacterium Abscessus Lung Disease, Rapidly Growing Mycobacterial Lung Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
10 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- History of tetracycline allergy


- If a menstruating female, not pregnant and on adequate birth control

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Mycobacterium Abscessus Lung Disease, Rapidly Growing Mycobacterial Lung DiseaseTigecycline for Treatment of Rapidly Growing Mycobacteria
NCT00600600
  1. Tyler, Texas
ALL GENDERS
10 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Tigecycline for Treatment of Rapidly Growing Mycobacteria
Official Title  ICMJE Use of Tigecycline for Treatment of Serious Infection Due to Rapidly Growing Mycobacteria (Especially M.Abscessus)
Brief Summary To determine the safety, tolerance, and efficacy of Tigecycline when given daily to patients with rapidly growing mycobacterial disease (especially M.abscessus).
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Mycobacterium Abscessus Lung Disease
  • Rapidly Growing Mycobacterial Lung Disease
Intervention  ICMJE Drug: Tigecycline
Tigecycline dosage based on age and clinical status of patient.
Other Name: tygacil
Study Arms  ICMJE Experimental: Tigecycline
tigecycline titrated dose according to patient age and clinical status
Intervention: Drug: Tigecycline
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 14, 2008)
8
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 10 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00600600
Other Study ID Numbers  ICMJE 660
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Richard J. Wallace, Jr., M.D., The University of Texas Health Science Center at Tyler
Study Sponsor  ICMJE The University of Texas Health Science Center at Tyler
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator:Richard J Wallace Jr., M.D.The University of Texas Health Science Center at Tyler
PRS Account The University of Texas Health Science Center at Tyler
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP