Status:
COMPLETED
Metronidazole for Pulmonary Tuberculosis (South Korea)
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Tuberculosis
Multi-Drug Resistant Tuberculosis
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
This study will evaluate the effect of adding metronidazole to standard second-line therapy for tuberculosis in patients who have multi-drug resistant tuberculosis (MDR-TB) of the lungs. It will evalu...
Detailed Description
BACKGROUND: Despite significant in vitro data that metronidazole is active against Mycobacterium tuberculosis (MTB) maintained under anaerobic conditions, the utility of this agent has not been evalu...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Male and females age 20 and above
- Signs or symptoms of tuberculosis (i.e., cough that has lasted 3 weeks or longer, hemoptysis, chest pain, fatigue, weight loss, night sweats)
- Subjects with documented AFB smear-positive pulmonary tuberculosis at screening to NMTH
- Radiographic evidence of tuberculous disease of the lung(s)
- TB isolate resistant to at least isoniazid and rifampicin
- Drug Susceptibility Testing (DST) results known for ofloxacin (can be either sensitive or resistant)
- Ability and willingness to give written or oral informed consent
- Willingness to be an inpatient at NMTH for, at minimum, the duration of study drug/placebo treatment
- Willingness to have samples stored
- Available for follow-up visits
- EXCLUSION CRITERIA:
- People who are unwilling or unable to abstain from alcohol consumption for the study drug treatment duration (8 weeks)
- Women of childbearing potential, who are pregnant, breast feeding, or unwilling to avoid pregnancy by the use of appropriate contraception including oral and subcutaneous implantable hormonal contraceptives, condoms, diaphragm, intrauterine device (IUD), or abstinence from sexual intercourse at study screening and during the study drug/placebo treatment (two months with allowed stops) (Note: Prospective female participants of childbearing potential must have negative pregnancy test (urine) within 48 hours prior to study entry.)
- Subjects with pan resistant isolates
- Presently taking 2nd -line agents started more than 14 days prior to initial FDG-PET scan
- People with any of the following in their current medical assessment:
- Absolute neutrophil count less than 1000 cells/mL
- White Blood Cell count (WBC) less than 3.0 X 10(3)/microliter
- Hemoglobin less than 7.0 g/dL
- Platelet count less than 75,000 cells/mm(3)
- Serum creatinine greater than 2.0 mg/dL
- Aspartate aminotransferase (AST or SGOT) greater than 100 IU/L
- Alanine aminotransferase (ALT or SGPT) greater than 100 IU/L
- Total bilirubin greater than 2 mg/dL
- Moderate or severe peripheral neuropathy
- HIV-1 or HIV-2 infection
- History of systemic lupus erythematosus, rheumatoid arthritis, or other connective tissue disease
- Terminal illness with impending mortality
- History of allergy or serious adverse reaction to metronidazole or placebo formulation used in this study
- The use of any of the following drugs within 30 days prior to study or anticipated use of these drugs within the next 60 days:
- Systemic cancer chemotherapy
- Systemic corticosteroids
- Systemic investigational agents
- Antiretroviral medications
- Growth factors
- HIV vaccines
- Immune globulin
- Interleukins
- Interferons
- The need for ongoing therapy with warfarin, phenytoin, lithium, cimetidine, disulfiram, ergot derivatives, cholestyramine, fosphenytoin, carbamazepine, cyclosporine, tacrolimus, sirolimus, amiodarone or phenobarbital while on study drug.
- Any other serious systemic illness requiring treatment and/or hospitalization until subject either completes therapy or is clinically stable on therapy for at least 14 days prior to study entry
- Unwilling to be an inpatient at NMTH for greater than or equal to 2 months
- Any condition that the investigator believes would warrant exclusion
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00425113
Start Date
December 1 2006
End Date
February 1 2013
Last Update
July 10 2013
Active Locations (2)
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1
National Masan Tuberculosis Hospital
Masan, South Korea
2
Yonsei University College of Medicine
Seoul, South Korea