Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000796
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
A Prospective Study of Multidrug Resistance and a Pilot Study of the Safety of and Clinical and Microbiologic Response to Levofloxacin in Combination With Other Antimycobacterial Drugs for Treatment of Multidrug-Resistant Pulmonary Tuberculosis MDRTB in HIV-Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Prospective Study of Multidrug Resistance and a Pilot Study of the Safety of and Clinical and Microbiologic Response to Levofloxacin in Combination With Other Antimycobacterial Drugs for Treatment of Multidrug-Resistant Pulmonary Tuberculosis MDRTB in HIV-Infected Patients
Status:
COMPLETED
Status Verified Date:
2021-10
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 determine the demographic behavioral clinical and geographic risk factors associated with the occurrence of multidrug-resistant pulmonary tuberculosis MDRTB To evaluate the clinical and microbiological responses and overall survival of MDRTB patients who are treated with levofloxacin-containing multiple-drug regimens chosen from a hierarchical list Per 92894 amendment to assess whether persistent or recurrent positive sputum cultures of patients who show failure or relapse are due to the same strain or reinfection with a new strain
Among TB patients there has been an increase in progressive disease due to the emergence of antimycobacterial drug-resistant strains of Mycobacterium tuberculosis Failure to identify patients at high risk for MDRTB increases the hazard for both treatment failure and development of resistance to additional therapeutic agents Efforts to improve survival in patients with MDRTB will depend on improved methods of assessing the risk of acquisition of MDRTB and identifying drug susceptibility patterns in a timely fashion
Among TB patients there has been an increase in progressive disease due to the emergence of antimycobacterial drug-resistant strains of Mycobacterium tuberculosis Failure to identify patients at high risk for MDRTB increases the hazard for both treatment failure and development of resistance to additional therapeutic agents Efforts to improve survival in patients with MDRTB will depend on improved methods of assessing the risk of acquisition of MDRTB and identifying drug susceptibility patterns in a timely fashion
Detailed Description:
Among TB patients there has been an increase in progressive disease due to the emergence of antimycobacterial drug-resistant strains of Mycobacterium tuberculosis Failure to identify patients at high risk for MDRTB increases the hazard for both treatment failure and development of resistance to additional therapeutic agents Efforts to improve survival in patients with MDRTB will depend on improved methods of assessing the risk of acquisition of MDRTB and identifying drug susceptibility patterns in a timely fashion
Patients are asked a series of questions to determine epidemiologic factors that may be predictive of MDRTB Patients who are determined to be at low risk for MDRTB will be referred to another TB treatment protocol ACTG 222 if appropriate Patients suspected of having primary or acquired MDRTB or those with confirmed MDRTB will be offered a regimen of anti-TB therapy from a hierarchically ordered list of drugs based on the patients resistance status suspect primary MDRTB suspect acquired MDRTB or confirmed MDRTB The hierarchical list is as follows isoniazid rifampin ethambutol streptomycin levofloxacin ethionamide cycloserine capreomycin aminosalicylic acid and clofazimine Treatment will be administered daily for at least 6 months then on an intermittent schedule at the clinicians discretion Patients with confirmed MDRTB defined as known resistance to at least isoniazid and rifampin within 6 months prior to study entry will receive a minimum of 18 months of treatment following sputum culture conversion Follow-up is performed every 4 weeks for 8 weeks and then every 8 weeks
Patients are asked a series of questions to determine epidemiologic factors that may be predictive of MDRTB Patients who are determined to be at low risk for MDRTB will be referred to another TB treatment protocol ACTG 222 if appropriate Patients suspected of having primary or acquired MDRTB or those with confirmed MDRTB will be offered a regimen of anti-TB therapy from a hierarchically ordered list of drugs based on the patients resistance status suspect primary MDRTB suspect acquired MDRTB or confirmed MDRTB The hierarchical list is as follows isoniazid rifampin ethambutol streptomycin levofloxacin ethionamide cycloserine capreomycin aminosalicylic acid and clofazimine Treatment will be administered daily for at least 6 months then on an intermittent schedule at the clinicians discretion Patients with confirmed MDRTB defined as known resistance to at least isoniazid and rifampin within 6 months prior to study entry will receive a minimum of 18 months of treatment following sputum culture conversion Follow-up is performed every 4 weeks for 8 weeks and then every 8 weeks
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 |
|---|---|---|---|
| 11215 | REGISTRY | DAIDS ES Registry Number | None |
| CPCRA 026 | None | None | None |