Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004444
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Brief Title:
Pilot Randomized Study of Paromomycin Aminosidine vs Streptomycin for Uncomplicated Pulmonary Tuberculosis
Sponsor:
FDA Office of Orphan Products Development
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UIC-FDR001167 | None | None | None |