Status:
WITHDRAWN
Pimonidazole Hydrochloride to Detect Low Oxygen in Tuberculosis-Infected Lungs
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
International Tuberculosis Research Center
Conditions:
Refractory Pulmonary Tuberculosis
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief 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 fi...
Detailed Description
The purpose of this Phase II clinical trial is to establish whether pulmonary tuberculous lesions are hypoxic or contain hypoxic microenvironments using an in vivo hypoxia-imaging marker, pimonidazole...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Males and females age 20 and above.
- Subjects with treatment-refractory pulmonary TB (i.e., who remain sputum AFB smear positive and/or culture positive or who are sputum negative yet non-responsive by radiographic and clinical measures) (including MDR-TB) scheduled for elective pulmonary resection.
- Subjects who demonstrate one or more radiographic abnormalities associated with pulmonary tuberculosis (i.e., cavities, nodules, consolidation, fibrosis, or calcified lesions).
- Ability and willingness to utilize contraceptives (such as latex condom, diaphragm, cervical cap, IUD, hormonal contraception, tubal ligation, or vasectomy) from the time of consent to one month after the treatment period (both men and women).
- Ability and willingness to give written or oral informed consent.
- EXCLUSION CRITERIA:
- Subjects under the age of 20.
- Pregnant and breast-feeding women.
- Subjects with underlying neurological disease including seizure disorder and peripheral neuropathy.
- Subjects taking medications with a high incidence of central nervous system (CNS) toxicity (including cycloserine), within one week before or after the scheduled pimonidazole infusion or will be anticipated to need such drugs within one week after infusion.
- Subjects taking the following medications within one week before or will be anticipated to need such drugs after the scheduled infusion: oral anticoagulants, Cimetadine, Didasnosine, Disulfiram, Nisatidine, Ocytetracycline, Phenobarbital, or Phenytoin.
- Liver dysfunction with serum transaminases \[AST (SGOT), ALT (SGPT)\] and/or total bilirubin greater than 1.5 times ULN.
- Evidence of hepatitis as indicated by a positive HBV surface antigen test or a positive HCV antibody titer suggesting chronic infection.
- History of excessive alcohol use or alcohol abuse within the last year.
- Renal insufficiency with serum creatinine greater than 1.5 times ULN.
- Subjects assessed by the chest surgeon or surgery staff to be a high operative risk due to the presence of one or more underlying co-morbidities such as severe coronary artery disease, immunosuppression, or chronic obstructive pulmonary disease (COPD).
- Administration of any investigational test article within 30 days preceding the first dose of study drug.
Exclusion
Key Trial Info
Start Date :
September 5 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00374517
Start Date
September 5 2006
End Date
February 2 2010
Last Update
July 2 2017
Active Locations (2)
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1
International Tuberculosis Research Center
Masan, South Korea
2
National Masan Tuberculosis Hospital
Masan, South Korea