Pilot Randomized Study of Paromomycin (Aminosidine) Vs Streptomycin for Uncomplicated Pulmonary Tuberculosis
OBJECTIVES: I. Compare the pharmacokinetics and early bactericidal activity of paromomycin (aminosidine) vs streptomycin for the treatment of uncomplicated pulmonary tuberculosis.
II. Compare the tolerability of these two drugs in these patients. III. Establish the relationships between achieved serum concentration, minimal inhibitory concentration, and early bactericidal activity of paromomycin and streptomycin.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Primary Purpose: Treatment
|Study Start Date:||November 1994|
|Estimated Study Completion Date:||January 2001|
PROTOCOL OUTLINE: This is a randomized study. Patients are randomized to one of three treatment arms. Patients in arms I and II receive one of two doses of paromomycin intramuscularly once a day for 3 days. Patients in arm III receive streptomycin intramuscularly once a day for 3 days. All patients then begin a course of standard therapy for tuberculosis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004444
|Study Chair:||Thomas Paul Kanyok||University of Illinois at Chicago|