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.
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ClinicalTrials.gov Identifier: NCT00000796 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: April 3, 2012
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Tracking Information | |||||||||||||
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First Submitted Date ICMJE | November 2, 1999 | ||||||||||||
First Posted Date ICMJE | August 31, 2001 | ||||||||||||
Last Update Posted Date | April 3, 2012 | ||||||||||||
Study Start Date ICMJE | Not Provided | ||||||||||||
Primary Completion Date | Not Provided | ||||||||||||
Current Primary Outcome Measures ICMJE | Not Provided | ||||||||||||
Original Primary Outcome Measures ICMJE | Not Provided | ||||||||||||
Change History | Complete list of historical versions of study NCT00000796 on ClinicalTrials.gov Archive Site | ||||||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
Descriptive Information | |||||||||||||
Brief Title ICMJE | 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. | ||||||||||||
Official Title ICMJE | 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. | ||||||||||||
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 9/28/94 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. |
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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 patient's 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 clinician's 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. |
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Study Type ICMJE | Interventional | ||||||||||||
Study Phase | Not Applicable | ||||||||||||
Study Design ICMJE | Primary Purpose: Treatment | ||||||||||||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms | Not Provided | ||||||||||||
Publications * | Telzak EE, Chirgwin KD, Nelson ET, Matts JP, Sepkowitz KA, Benson CA, Perlman DC, El-Sadr WM. Predictors for multidrug-resistant tuberculosis among HIV-infected patients and response to specific drug regimens. Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA) and the AIDS Clinical Trials Group (ACTG), National Institutes for Health. Int J Tuberc Lung Dis. 1999 Apr;3(4):337-43. | ||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||
Enrollment ICMJE |
525 | ||||||||||||
Original Enrollment ICMJE | Same as current | ||||||||||||
Actual Study Completion Date | October 1998 | ||||||||||||
Primary Completion Date | Not Provided | ||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria Patients must have:
Per 08/02/94 amendment, patients with confirmed MDRTB or known susceptibilities for the current episode at baseline are not eligible for the epidemiologic study only. FOR TREATMENT PILOT:
Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded:
Prior Medication: Excluded:
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Sex/Gender |
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Ages | 13 Years and older (Child, Adult, Senior) | ||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
Listed Location Countries ICMJE | United States | ||||||||||||
Removed Location Countries | |||||||||||||
Administrative Information | |||||||||||||
NCT Number ICMJE | NCT00000796 | ||||||||||||
Other Study ID Numbers ICMJE | ACTG 238 CPCRA 026 11215 ( Registry Identifier: DAIDS ES Registry Number ) |
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Has Data Monitoring Committee | Not Provided | ||||||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||||||
IPD Sharing Statement | Not Provided | ||||||||||||
Responsible Party | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||||||
Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||
Investigators ICMJE |
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PRS Account | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||||||
Verification Date | March 2012 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |