Search / Trial NCT00000778

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of December 03, 2023

Completed

Keywords

Isoniazid Tuberculosis, Pulmonary Pyridoxine Ofloxacin Aids Related Opportunistic Infections Drug Evaluation Acquired Immunodeficiency Syndrome Sputum Colony Count, Microbial

Description

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 pa...

Gender

All

Eligibility 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.

Attachments

readout_NCT00000778_2023-12-03.pdf

4.5 MB

NCT00000778_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Birmingham, Alabama, United States

New Orleans, Louisiana, United States

Chicago, Illinois, United States

Fort Lauderdale, Florida, United States

Dallas, Texas, United States

Los Angeles, California, United States

Torrance, California, United States

Miami, Florida, United States

Galveston, Texas, United States

Houston, Texas, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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