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OpenTrials
Completed

NCT Number: NCT00600600

Tigecycline for Treatment of Rapidly Growing Mycobacteria

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

Completed

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Key information

Conditions

Mycobacterium Abscessus Lung Disease Rapidly Growing Mycobacterial Lung Disease

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The University of Texas Health Science Center at Tyler

Tyler, Texas, 75708, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tigecycline

Drug

Tigecycline dosage based on age and clinical status of patient.

Other names: tygacil

Primary outcomes

  1. Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures

    Time frame: 6 mos

    culture neg X3 ( sputum conversion)

Secondary outcomes

  1. clinical and Microbiological outcomes

    Time frame: 6 mos

    clinical and radiographic improvements

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at Tyler

Other

Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2010
Study completion
2010
First posted
Jan 25, 2008
Registry last updated
May 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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