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

Completed · Phase 1

Conditions studied: HIV Infections, Tuberculosis

In brief

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.

Key facts

Study ID

NCT00000778

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

44

Last updated by the study team

2008-08-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:

Where it is running

• Univ of Alabama at Birmingham — Birmingham, Alabama, United States
• UCLA Med Ctr — Los Angeles, California, United States
• Harbor - UCLA Med Ctr — Torrance, California, United States
• Broward Gen Med Ctr — Fort Lauderdale, Florida, United States
• Univ of Miami / Jackson Memorial Hosp — Miami, Florida, United States
• Univ of Illinois — Chicago, Illinois, United States
• Tulane Univ Med School — New Orleans, Louisiana, United States
• Univ of Texas Southwestern Med Ctr of Dallas — Dallas, Texas, United States
• Univ TX Galveston — Galveston, Texas, United States
• Baylor College of Medicine / Houston Veterans Adm Med Ctr — Houston, Texas, United States

Full record on ClinicalTrials.gov

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