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Sponsors and Collaborators: |
FDA Office of Orphan Products Development University of Illinois |
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Information provided by: | FDA Office of Orphan Products Development |
ClinicalTrials.gov Identifier: | NCT00004444 |
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.
Condition | Intervention |
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Tuberculosis, Pulmonary |
Drug: paromomycin Drug: streptomycin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Pharmacokinetics/Dynamics Study |
Estimated Enrollment: | 24 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
Study ID Numbers: | 199/13445, UIC-FDR001167 |
Study First Received: | October 18, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004444 History of Changes |
Health Authority: | United States: Federal Government |
bacterial infection immunologic disorders and infectious disorders mycobacterium infection mycobacterium tuberculosis infection rare disease |
Bacterial Infections Anti-Bacterial Agents Gram-Positive Bacterial Infections Respiratory Tract Infections Respiratory Tract Diseases Lung Diseases |
Tuberculosis, Pulmonary Rare Diseases Mycobacterium Infections Tuberculosis Streptomycin Paromomycin |
Bacterial Infections Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Streptomycin Pharmacologic Actions Actinomycetales Infections Paromomycin Protein Synthesis Inhibitors Anti-Bacterial Agents |
Antiparasitic Agents Gram-Positive Bacterial Infections Respiratory Tract Diseases Respiratory Tract Infections Therapeutic Uses Lung Diseases Tuberculosis, Pulmonary Mycobacterium Infections Tuberculosis Amebicides |