Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00082173
Status:
COMPLETED
Last Update Posted:
2013-05-22
First Post:
2004-04-30
Brief Title:
Moxifloxacin As Part of a Multi-Drug Regimen For Tuberculosis
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Phase 2 Randomized Trial of a Moxifloxacin-Containing Regimen For Treatment of Smear-Positive Pulmonary Tuberculosis in Adults With and Without HIV Infection
Status:
COMPLETED
Status Verified Date:
2013-03
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:
Current treatment of tuberculosis TB requires patients to take four drugs for 8 weeks and then two drugs for 4 months New drug regimens that are shorter and effective against drug-resistant TB are needed This study will evaluate whether using the drug moxifloxacin MOX in place of ethambutol EMB during the first 8 weeks of treatment will effectively treat TB
Detailed Description:
Approximately one-third of the worlds population is infected with Mycoplasma tuberculosis 7 to 8 million new cases of active TB occur each year TB is the second most common infectious cause of death worldwide Appropriate treatment of persons with active TB is very important in limiting the transmission of M tuberculosis and preventing TB-related mortality Current therapy requires 6 months of a four-drug regimen of isoniazid INH rifampin RIF pyrazinamide PZA and EMB
The development of alternative regimens is a priority and new classes of antituberculosis agents are needed to provide treatment options for patients with drug-resistant disease This study will evaluate the effectiveness of replacing EMB with MOX in a multi-drug regimen in the initial phase of treatment of smear-positive pulmonary TB in patients with and without HIV infection
Participants in this study will be randomly assigned to receive either a MOX-containing drug regimen or the standard EMB-containing drug regimen for 8 weeks Participants will have study visits weekly during these 8 weeks After 8 weeks participants will discontinue MOX EMB and PZA and will continue taking INH and RFP for 4 months Participants will have study visits at Months 4 6 12 and 18 Study visits will include a medical interview physical exam blood and urine tests and sputum tests for TB
The development of alternative regimens is a priority and new classes of antituberculosis agents are needed to provide treatment options for patients with drug-resistant disease This study will evaluate the effectiveness of replacing EMB with MOX in a multi-drug regimen in the initial phase of treatment of smear-positive pulmonary TB in patients with and without HIV infection
Participants in this study will be randomly assigned to receive either a MOX-containing drug regimen or the standard EMB-containing drug regimen for 8 weeks Participants will have study visits weekly during these 8 weeks After 8 weeks participants will discontinue MOX EMB and PZA and will continue taking INH and RFP for 4 months Participants will have study visits at Months 4 6 12 and 18 Study visits will include a medical interview physical exam blood and urine tests and sputum tests for TB
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