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Generated: November 17, 2018

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CLINICAL TRIALS PROFILE FOR LEVOFLOXACIN

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Clinical Trials for Levofloxacin

Trial ID Title Status Sponsor Phase 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 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 (MDRT Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A 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 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.
NCT00005590 Levofloxacin to Prevent Infection Following Chemotherapy in Treating Patients With Solid Tumors or Lymphoma Completed Cancer Research Campaign Clinical Trials Centre Phase 3 RATIONALE: Giving antibiotics may be effective in preventing or controlling early infection in patients receiving chemotherapy for solid tumors or lymphoma. It is not yet known if levofloxacin if effective in preventing infection. PURPOSE: Randomized phase III trial to determine the effectiveness of levofloxacin in preventing infection in patients receiving chemotherapy for solid tumors or lymphoma.
NCT00020865 Levofloxacin Compared With Cefepime in Treating Cancer Patients With Fever and Neutropenia Unknown status National Cancer Institute (NCI) Phase 3 RATIONALE: Levofloxacin may be effective in reducing fever and controlling other symptoms of neutropenia in patients who are being treated for cancer. It is not yet known whether levofloxacin is more effective than cefepime in reducing fever and controlling symptoms of neutropenia. PURPOSE: Randomized phase III trial to compare the effectiveness of levofloxacin with that of cefepime in reducing fever and controlling symptoms of neutropenia in patients who are being treated for cancer.
NCT00020865 Levofloxacin Compared With Cefepime in Treating Cancer Patients With Fever and Neutropenia Unknown status Jonsson Comprehensive Cancer Center Phase 3 RATIONALE: Levofloxacin may be effective in reducing fever and controlling other symptoms of neutropenia in patients who are being treated for cancer. It is not yet known whether levofloxacin is more effective than cefepime in reducing fever and controlling symptoms of neutropenia. PURPOSE: Randomized phase III trial to compare the effectiveness of levofloxacin with that of cefepime in reducing fever and controlling symptoms of neutropenia in patients who are being treated for cancer.
NCT00034736 A Study to Compare the Efficacy and Safety of Levofloxacin in the Treatment of Children With Community-acquired Pneumonia in the Hospital or Outpatient Setting Completed Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Phase 3 The purpose of this study is to determine the safety and efficacy of levofloxacin in the treatment of children with community acquired pneumonia.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Levofloxacin

Condition Name

Condition Name for Levofloxacin
Intervention Trials
Helicobacter Pylori Infection 16
Pneumonia 8
Tuberculosis 6
Infection 6
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Condition MeSH

Condition MeSH for Levofloxacin
Intervention Trials
Infection 38
Communicable Diseases 29
Pneumonia 25
Helicobacter Infections 22
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Clinical Trial Locations for Levofloxacin

Trials by Country

Trials by Country for Levofloxacin
Location Trials
United States 467
Canada 39
China 28
South Africa 24
Germany 23
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Trials by US State

Trials by US State for Levofloxacin
Location Trials
Florida 27
California 26
Texas 24
Pennsylvania 20
Ohio 20
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Clinical Trial Progress for Levofloxacin

Clinical Trial Phase

Clinical Trial Phase for Levofloxacin
Clinical Trial Phase Trials
Phase 4 55
Phase 3 68
Phase 2/Phase 3 9
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Clinical Trial Status

Clinical Trial Status for Levofloxacin
Clinical Trial Phase Trials
Completed 109
Recruiting 42
Not yet recruiting 14
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Clinical Trial Sponsors for Levofloxacin

Sponsor Name

Sponsor Name for Levofloxacin
Sponsor Trials
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. 25
PriCara, Unit of Ortho-McNeil, Inc. 21
National Taiwan University Hospital 9
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Sponsor Type

Sponsor Type for Levofloxacin
Sponsor Trials
Other 261
Industry 124
NIH 11
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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Chinese Patent Office
Accenture
Merck
Express Scripts
Farmers Insurance
Argus Health
Cipla
Fuji

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