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Pilot Randomized Study of Paromomycin (Aminosidine) vs Streptomycin for Uncomplicated Pulmonary Tuberculosis

Tuberculosis, Pulmonary Clinical Trial

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00004444
Study type Interventional
Source FDA Office of Orphan Products Development
Contact
Status Completed
Phase N/A
Start date November 1994
Completion date January 2001
View Details
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