Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000778
Status:
COMPLETED
Last Update Posted:
2008-08-08
First Post:
1999-11-02
Brief Title:
A Pilot Study of Methodology to Rapidly Evaluate Drugs for Bactericidal Activity Tolerance and Pharmacokinetics in the Treatment of Pulmonary Tuberculosis Using Isoniazid and Levofloxacin
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Pilot Study of Methodology to Rapidly Evaluate Drugs for Bactericidal Activity Tolerance and Pharmacokinetics in the Treatment of Pulmonary Tuberculosis Using Isoniazid and Levofloxacin
Status:
COMPLETED
Status Verified Date:
1995-06
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:
To evaluate the methodology for rapidly determining the early bactericidal activity EBA tolerance and pharmacokinetics of isoniazid and levofloxacin in the treatment of pulmonary tuberculosis TB
Traditionally in trials for treatment of TB a new drug is administered in combination with two or more other antituberculous agents of known effectiveness over a long period of time In this setting it is difficult to determine the effect of any single drug or dose level Development of new agents for the treatment of TB may be accelerated by a methodology in which a new agent could be evaluated for activity by administering it as a single agent over a short time period This study utilizes a method to measure the amount of bacteria present each day in the lungs
Traditionally in trials for treatment of TB a new drug is administered in combination with two or more other antituberculous agents of known effectiveness over a long period of time In this setting it is difficult to determine the effect of any single drug or dose level Development of new agents for the treatment of TB may be accelerated by a methodology in which a new agent could be evaluated for activity by administering it as a single agent over a short time period This study utilizes a method to measure the amount of bacteria present each day in the lungs
Detailed Description:
Traditionally in trials for treatment of TB a new drug is administered in combination with two or more other antituberculous agents of known effectiveness over a long period of time In this setting it is difficult to determine the effect of any single drug or dose level Development of new agents for the treatment of TB may be accelerated by a methodology in which a new agent could be evaluated for activity by administering it as a single agent over a short time period This study utilizes a method to measure the amount of bacteria present each day in the lungs
An initial cohort of patients receive isoniazid with pyridoxine daily for 5 days Sputum samples are collected daily for determination of the EBA decline in colony-forming unitsml sputum If the methodology is validated additional patients are randomized to receive one of two doses of levofloxacin daily for 5 days with determination of EBA All patients are hospitalized for 2 days of baseline evaluation and 5 days of treatment
An initial cohort of patients receive isoniazid with pyridoxine daily for 5 days Sputum samples are collected daily for determination of the EBA decline in colony-forming unitsml sputum If the methodology is validated additional patients are randomized to receive one of two doses of levofloxacin daily for 5 days with determination of EBA All patients are hospitalized for 2 days of baseline evaluation and 5 days of treatment
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?: