Status:
COMPLETED
Measurement of Anti-TB Drugs in Lung Tissue From Patients Having Surgery to Treat Tuberculosis
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Korean Center for Disease Control and Prevention
International Tuberculosis Research Center
Conditions:
Tuberculosis
Eligibility:
All Genders
20-100 years
Phase:
PHASE1
Brief Summary
This study, conducted jointly by researchers at the National Masan TB Hospital, Asan and Samsung Medical Centers in Seoul, Republic of Korea, and the Yonsei University and the NIH in the United States...
Detailed Description
It takes 6 to 24 months of intensive combination therapy to cure tuberculosis (TB) with antibiotics that have proven activity in vitro. In contrast, many pulmonary infectious diseases can be cured fol...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Males and females age 20 and above
- Selected for lung resection due to anti-tuberculous treatment failure, multidrug resistant disease, or other reason determined by the treating physician
- Radiographic evidence of tuberculous disease of the lung(s)
- If already on an aminoglycoside, ability and willingness to substitute this aminoglycoside with KM for the one study dose
- Willingness to receive MRI scan and marker and Gadolinium injection
- Willingness to have samples stored
- Ability and willingness to give written or oral informed consent
- EXCLUSION CRITERIA:
- Subjects less than 20 years of age
- Women of childbearing potential who are pregnant, breast feeding, or unwilling to avoid pregnancy (i.e., the use of appropriate contraception including oral and subcutaneous implantable hormonal contraceptives, condoms, diaphragm, intrauterine device (IUD), or abstinence from sexual intercourse) \[Note: Prospective female participants of childbearing potential must have negative pregnancy test (urine) within 48 hours prior to study entry.\]
- Allergy or hypersensitivity to any of the 5 study drugs, any aminoglycoside, or rifamycin (those allergic to fluoroquinolones will not receive MXF).
- Those with severe gout
- Severe claustrophobia or Gadolinium hypersensitivity (tbc)
- Renal, hepatic, auditory and/or vestibular impairment.
- Serum creatinine greater than 2.0 mg/dL (renal)
- Aspartate aminotransferase (AST or SGOT) greater than 100 IU/L (LFTs)
- Alanine aminotransferase (ALT or SGPT) greater than 100 IU/L (LFTs)
- Total bilirubin greater than 2.0 mg/dL (LFTs)
- The use of any of Rifampicin (RIF), Rifapentine or Rifabutin within 30 days prior to the study
- HIV infection, determined by a positive HIV test performed with the past 6 months
- The use of any of the following drugs within 30 days prior to study:
- Systemic cancer chemotherapy
- Systemic corticosteroids (oral or IV only) with the following
- exceptions (i.e.the following are NOT exclusion criteria): intranasal, topical, and inhaled corticosteroids, a short course (10 days or less) of corticosteroids for a non-chronic condition completed at least 2 weeks prior to enrollment in this study
- Systemic IND agents other than Linezolid
- Antiretroviral medications
- Growth factors
- The need for ongoing therapy with warfarin, phenytoin, lithium cholestrymine, levodopa, cimetidine, disulfiram, ergot derivatives, fosphenytoin, carbamazepine, cyclosporine, tacrolimus, sirolimus, amiodarone or Phenobarbital (If a potential subject is on one of these medications but it is being stopped per standard of care, to be eligible for the study the drug must be stopped at least one day prior to receiving study drug. A longer washout period is not necessary.) The only exception to this is amiodarone; because of amiodarone s long half-life and potential for QT prolongation, it should be stopped at least 60 days prior to receiving study drugs.
Exclusion
Key Trial Info
Start Date :
December 29 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 29 2017
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00816426
Start Date
December 29 2008
End Date
December 29 2017
Last Update
December 9 2019
Active Locations (3)
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1
Pusan National Unversity Hospital (PNUH)
Busan, South Korea
2
Asan Medical Center
Seoul, South Korea
3
National Medical Center
Seoul, South Korea