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| ID | Type | Description | Link |
|---|---|---|---|
| UIC-FDR001167 |
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| Name | Class |
|---|---|
| University of Illinois at Chicago | OTHER |
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paromomycin | Drug | |||
| streptomycin | Drug |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Paul Kanyok | University of Illinois at Chicago | Study Chair |
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| ID | Term |
|---|---|
| D014397 | Tuberculosis, Pulmonary |
| D001424 | Bacterial Infections |
| D007154 | Immune System Diseases |
| D003141 | Communicable Diseases |
| D009164 | Mycobacterium Infections |
| D014376 | Tuberculosis |
| D035583 | Rare Diseases |
| ID | Term |
|---|---|
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D010303 | Paromomycin |
| D013307 | Streptomycin |
| ID | Term |
|---|---|
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |