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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 Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on 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 conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. 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 Clinical research trials and 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 medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like 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. 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 Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a 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 clinical trial. Subjects typically recieve the finest healthcare available for their 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 condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > 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  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
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
For Condition: HIV Infections,Tuberculosis
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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 units/ml 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.
Eligibility:
Study Type: Interventional, Treatment, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed in all patients: - Antacids if administered more than 2 hours before or after study drug. Allowed in isoniazid patients: - Anticonvulsant therapy if blood levels are monitored. Allowed in levofloxacin patients: - Acceptable medications other than antacids if administered at least 2 hours before or 1 hour after study drug. - Anticonvulsant therapy, theophylline, or warfarin if doses are monitored. Patients must have: - Presumptive active pulmonary TB. - No clinical evidence of central nervous system or miliary tuberculosis. NOTE: - Both HIV-positive and HIV-negative patients are eligible. NOTE: - Pregnant women may be enrolled in the isoniazid cohort only. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Active or suspected MAI infection. - Active or suspected hepatitis. - Any other serious acute infection, diabetes, chronic obstructive pulmonary disease, malignancy requiring chemotherapy, or major organ dysfunction. - Extreme illness or toxic appearance. - Pregnancy (if entering the levofloxacin portion of the study). Concurrent Medication: Excluded: - All standard TB therapies. - Clofazimine. - Rifabutin. - Quinolones. - Aminoglycosides. - Corticosteroids. - Pentoxifylline. - Colony-stimulating factors. - Interferons. - Interleukins. - Disulfiram (patients receiving isoniazid). Patients with the following prior conditions are excluded: - History of treatment-limiting intolerance or known hypersensitivity to isoniazid (in patients receiving isoniazid) or to quinolones (in patients receiving levofloxacin). - Vomiting or diarrhea >= grade 2 at screening or within 2 days prior to screening. - History of drug-resistant TB (in patients receiving isoniazid). Prior Medication: Excluded: - Any prior treatment or prophylaxis for TB if enrolling on the isoniazid cohort. - Any anti-TB drug within the past 12 weeks, including standard drugs against TB as well as clofazimine, rifabutin, and all quinolones and aminoglycosides. - Corticosteroids, pentoxifylline, colony-stimulating factors, interferons, or interleukins within the past 12 weeks. Known risk factors for multi-drug resistant (MDR) TB, including: - Domicile, shelter, or prison exposure to a known case of MDR TB within the past 6 months. - Residence in a specific domicile, shelter, or prison cell block within 6 months of a known outbreak of MDR TB. - Hospitalization, within the past 6 months, on a medical service or unit in which nosocomial transmission of MDR TB is known to have occurred.
Total Enrollment: 44
Location and Contact Information:
Overall Study Official:
HafnerR, Study Chair,
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, 33136
United States
Broward Gen Med Ctr
Ft. Lauderdale, Florida, 33316
United States
Univ TX Galveston
Galveston, Texas, 77550
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 352336505
United States
Harbor - UCLA Med Ctr
Torrance, California, 90502
United States
Baylor College of Medicine / Houston Veterans Adm Med Ctr
Houston, Texas, 77030
United States
UCLA Med Ctr
Los Angeles, California, 900951793
United States
Univ of Illinois
Chicago, Illinois, 60622
United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235
United States
Tulane Univ Med School
New Orleans, Louisiana, 701122699
United States
Additional Information:
Study ID Numbers: DATRI 008;
Study Start Date:
Record last reviewed: June 1995
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000778
Other Tuberculosis Studies:
1. A Registry of Tuberculosis Cases in the CPCRA
2. Phase II Placebo Controlled Study of Thalidomide in Patients With Mycobacterial and HIV Infections
3. The Treatment of Tuberculosis in HIV-Infected Patients
4. Tuberculosis in a Multiethnic Inner City Population
5. Disseminated Tuberculosis in HIV Infection
Related Studies:
Other Tuberculosis Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
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
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