Ignite Creation Date:
2024-05-06 @ 3:12 AM
Last Modification Date:
2024-10-26 @ 11:30 AM
Study NCT ID:
NCT02236078
Status:
COMPLETED
Last Update Posted:
2020-10-19
First Post:
2014-09-08
Brief Title:
Brief Bactericidal Activity of Anti-Tuberculosis Drugs
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Brief Bactericidal Activity of Anti-Tuberculosis Drugs in Drug-Resistant Tuberculosis
Status:
COMPLETED
Status Verified Date:
2020-01
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:
BBA
Brief Summary:
The investigators will determine the bactericidal activity of high-dose isoniazid against M tuberculosis isolates that are 1 susceptible to isoniazid at 20 mcgml but resistant at 01 and 04 mcgml or 2 susceptible at 04 mcgml but resistant at 01 mcgml when tested in the BD MGIT 960 system Further the investigators will investigate the molecular genetic determinants of these differences in susceptibility
To achieve these objectives the investigators will carry out an innovative variation on early bactericidal activity EBA study methodology Patients at risk for drug-resistant TB will be screened for INH resistance using approved molecular assays In those with INH-resistant TB the investigators will quickly perform phenotypic DSTs using the direct method in the Bactec Mycobacterium Growth Indicator Tube MGIT 960 system so results will be available within 7 days If the DST results show the susceptibility patterns noted above patients will receive 900 mgd INH 600 mg if 45kg and assess its effect with serial quantitative sputum cultures for 6 days If the concentration of viable bacteria decreases significantly the investigators will interpret this to mean the drug is having an effect If not the drug is ineffective After 6 days the patients will resume treatment according to national guidelines
In case the investigators identify drugs that are effective under these conditions the investigators will sequence known and putative genes associated with the action of these drugs for the mycobacterial isolates from these patients
To achieve these objectives the investigators will carry out an innovative variation on early bactericidal activity EBA study methodology Patients at risk for drug-resistant TB will be screened for INH resistance using approved molecular assays In those with INH-resistant TB the investigators will quickly perform phenotypic DSTs using the direct method in the Bactec Mycobacterium Growth Indicator Tube MGIT 960 system so results will be available within 7 days If the DST results show the susceptibility patterns noted above patients will receive 900 mgd INH 600 mg if 45kg and assess its effect with serial quantitative sputum cultures for 6 days If the concentration of viable bacteria decreases significantly the investigators will interpret this to mean the drug is having an effect If not the drug is ineffective After 6 days the patients will resume treatment according to national guidelines
In case the investigators identify drugs that are effective under these conditions the investigators will sequence known and putative genes associated with the action of these drugs for the mycobacterial isolates from these patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None