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Pimonidazole Hydrochloride to Detect Low Oxygen in Tuberculosis-Infected Lungs

NCT00374517 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-07-02

No results posted yet for this study

Summary

This study will determine whether a drug called pimonidazole hydrochloride shows areas of low oxygen in tuberculosis (TB)-infected lungs. Pimonidazole is a "low oxygen marker," an agent designed to find areas in the body that are not getting enough oxygen. If it is found that TB grows where oxygen is low, these results may help doctors decide what medicines would be most effective for treating TB.

Patients 20 years of age or older who are scheduled for lung surgery at the National Masan Tuberculosis Hospital in Masan, Korea to treat their TB may be eligible for this study.

Participants undergo the following procedures:

* Blood draw before surgery to test for hepatitis B and hepatitis C viruses.
* Pregnancy test for women who can become pregnant.
* Infusion of pimonidazole through a vein in the arm 24 hours before surgery. A part of the patient's lung is removed during surgery. This tissue is examined under a microscope for evidence of pimonidazole, which would indicate low oxygen.
* Blood sample collection during surgery and on the 7th and 14th days after surgery to check liver function.

Conditions

  • Refractory Pulmonary Tuberculosis

Interventions

DRUG

Pimonidazole hydrochloride

Sponsors & Collaborators

  • International Tuberculosis Research Center

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Purpose
TREATMENT

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-05
Primary Completion
2010-02-02
Completion
2010-02-02

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00374517 on ClinicalTrials.gov