Pilot Randomized Study of Paromomycin (Aminosidine) vs Streptomycin for Uncomplicated Pulmonary Tuberculosis
Tuberculosis, Pulmonary
About this trial
This is an interventional treatment trial for Tuberculosis, Pulmonary focused on measuring bacterial infection, immunologic disorders and infectious disorders, mycobacterium infection, mycobacterium tuberculosis infection, rare disease
Eligibility Criteria
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Microbiologically proven uncomplicated pulmonary tuberculosis Positive direct sputum smear for acid-fast bacilli OR Presumptive diagnosis based on clinical and radiological findings No known risk factors for multidrug resistant tuberculosis (MDR TB) including: Domicile, shelter, or prison exposure to MDR TB within 6 months Residence in a specific domicile, shelter, or prison cell block within 6 months of a known outbreak of MDR TB Hospitalization, within 6 months, on a medical service or unit in which nosocomial transmission of MDR TB is known to have occurred No clinical evidence of CNS or miliary tuberculosis HIV seronegative --Prior/Concurrent Therapy-- Biologic therapy: At least 12 weeks since immune modulators (including colony-stimulating factors, interferons, or interleukins) Chemotherapy: No concurrent chemotherapy Endocrine therapy: At least 12 weeks since corticosteroids Other: At least 2 years since treatment or prophylaxis for tuberculosis At least 12 weeks since treatment with any drug with activity against tuberculosis, including: All standard drugs used for tuberculosis Clofazimine Rifabutin Quinolones Aminoglycosides At least 12 weeks since pentoxifylline --Patient Characteristics-- Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Renal: Creatinine clearance greater than 60 mL/min Pulmonary: No chronic obstructive pulmonary disease Other: Not pregnant Fertile patients must use effective contraception No history of intolerance or known hypersensitivity to aminoglycosides No known or suspected Mycobacterium avium complex infection No other serious, acute infection No diabetes No major organ dysfunction No malignancy requiring chemotherapy