Status:
COMPLETED
Linezolid to Treat Extensively-Drug Resistant Tuberculosis
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Pulmonary Tuberculosis
Multidrug Resistant Tuberculosis
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
This study, conducted in Masan and Seoul, South Korea, investigated the effectiveness of linezolid (LZD) in treating patients with extensively drug resistant tuberculosis (XDR TB). Because regular med...
Detailed Description
World-wide, there is an increasing incidence of multi-drug resistant tuberculosis (MDR-TB) and extensively drug-resistant TB (XDR-TB). For patients diagnosed with either of these deadly diseases, effe...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Males and females age 20 and above
- Documented pulmonary tuberculosis at screening
- Radiographic evidence of tuberculous disease of the lung(s)
- History of chronic, AFB positive sputum smears and culture positive TB
- Mycobacterium species identification as Mycobacterium tuberculosis
- Confirmed resistance to INH, RIF, kanamycin, ofloxacin, and moxifloxacin by genotypic or phenotypic testing OR subjects with documented failure to respond to treatment despite DST susceptibility
- Failure to respond (after at least 6 months) to a anti-TB drug regimen including any known active agents
- Willingness to be an inpatient until 2 consecutive AFB-negative sputum smears
- When an outpatient, willing to come back for weekly tests and scheduled follow-up visits
- Willingness to have samples stored
- Ability and willingness to give written or oral informed consent
- EXCLUSION CRITERIA:
- Subjects below 20 years of age
- Subjects who have previously been on LZD
- 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). \[Note: Prospective female participants of childbearing potential must have negative pregnancy test (urine) within 48 hours prior to study entry.\]
- Men who are unwilling to use contraceptives or practice abstinence
- People with any of the following in their current medical assessments:
- Absolute neutrophil count less than 1000 cells/mL
- White blood cell count (WBC) less than 3.0 X 10(3)/microL
- 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 2.0 mg/dL
- Moderate or severe peripheral or optical neuropathy (or a history of)
- HIV-1 or HIV-2 infection
- Systemic lupus erythematosus, rheumatoid arthritis, or other connective tissue disease
- Patients who, in the investigator's judgment, are too ill to participate in the study
- History of allergy or serious adverse reaction to the LZD formulation used in this study
- Patients with anticipated surgical intervention
- 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: (Please not, bronchodilators and cough syrup (or similar cough medicines) are allowed before and during the study if blood pressure is monitored regularly, per Contraindications, p.12, of the Zyvox Package Insert.)
- Selective serotonin reuptake inhibitors (SSRIs)
- Monoamine oxidase inhibitors (MAOIs)
- Systemic cancer chemotherapy
- Systemic corticosteroids
- Systemic investigational agents
- Antiretroviral medications
- Growth factors
- HIV vaccines
- Immune globulin
- Interleukins
- Interferons
- The need for ongoing therapy with antidepressants (SSRI, MAOI), hydroxyzine, dopaminergic agents (such as Sinemet, dopamine, and dobutamine), lithium, cyclosporine, tacrolimus, sirolimus, and levodopa (such as sinemet) 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
- Patients who the physician has reason to believe may have been non-compliant in the previous 12 months of treatment
- SUBSTUDY ELIGIBILITY CRITERIA
- INCLUSION CRITERIA:
- Subjects who meet the inclusion criteria for main study are eligible for the substudy.
- EXCLUSION CRITERIA:
- Exclusion criteria for main study apply to the substudy with the exception that subjects with uncontrolled diabetes mellitus will be excluded from the substudy. The study physician may decide that a patient is healthy enough to participate in the main study but not the sub-study.
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00727844
Start Date
July 1 2008
End Date
November 1 2014
Last Update
March 14 2016
Active Locations (2)
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1
National Masan Tuberculosis Hospital
Changwon, South Korea
2
National Medical Center
Seoul, South Korea