CLINICAL TRIALS PROFILE FOR LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

All Clinical Trials for Levofloxacin In Dextrose 5% In Plastic Container

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	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.
NCT00000796 ↗	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 (MDR	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	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.
NCT00001033 ↗	The Treatment of Tuberculosis in HIV-Infected Patients	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	PER 5/30/95 AMENDMENT: To compare the combined rate of failure during therapy and relapse after therapy between two durations of intermittent therapy (6 versus 9 months) for the treatment of pulmonary tuberculosis (TB) in HIV-infected patients. To compare toxicity, survival, and development of resistance in these two regimens. ORIGINAL: To compare the efficacy and safety of induction and continuation therapies for the treatment of pulmonary TB in HIV-infected patients who are either from areas with known high rates of resistance to one or more anti-TB drugs or from areas where TB is expected to be susceptible to commonly used anti-TB drugs. PER 5/30/95 AMENDMENT: In HIV-negative patients, intermittent anti-TB therapy has been shown to be as effective as daily therapy, but the optimal duration of therapy in HIV-infected patients has not been established. ORIGINAL: In some areas of the country, resistance to one or more of the drugs commonly used to treat TB has emerged. Thus, the need to test regimens containing a new drug exists. Furthermore, the optimal duration of anti-TB therapy for HIV-infected patients with TB needs to be determined.

Clinical Trial Conditions for Levofloxacin In Dextrose 5% In Plastic Container

Condition Name

Condition Name for Levofloxacin In Dextrose 5% In Plastic Container
Intervention	Trials
Helicobacter Pylori Infection	41
Tuberculosis	8
Pneumonia	8

Condition MeSH

Condition MeSH for Levofloxacin In Dextrose 5% In Plastic Container
Intervention	Trials
Infections	63
Infection	52
Communicable Diseases	45

Clinical Trial Locations for Levofloxacin In Dextrose 5% In Plastic Container

Trials by Country

Trials by Country for Levofloxacin In Dextrose 5% In Plastic Container
Location	Trials
United States	521
China	91
Italy	56
Canada	40
South Africa	31

Trials by US State

Trials by US State for Levofloxacin In Dextrose 5% In Plastic Container
Location	Trials
Florida	29
California	29
Michigan	24
Texas	23
Pennsylvania	22

Clinical Trial Progress for Levofloxacin In Dextrose 5% In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Levofloxacin In Dextrose 5% In Plastic Container
Clinical Trial Phase	Trials
Phase 4	90
Phase 3	82
Phase 2/Phase 3	10

Clinical Trial Status

Clinical Trial Status for Levofloxacin In Dextrose 5% In Plastic Container
Clinical Trial Phase	Trials
Completed	157
Recruiting	39
Unknown status	38

Clinical Trial Sponsors for Levofloxacin In Dextrose 5% In Plastic Container

Sponsor Name

Sponsor Name for Levofloxacin In Dextrose 5% In Plastic Container
Sponsor	Trials
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	25
PriCara, Unit of Ortho-McNeil, Inc.	21
National Taiwan University Hospital	12

Sponsor Type

Sponsor Type for Levofloxacin In Dextrose 5% In Plastic Container
Sponsor	Trials
Other	420
Industry	150
NIH	15