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Last Updated: January 20, 2025

CLINICAL TRIALS PROFILE FOR LEVOFLOXACIN


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All Clinical Trials for Levofloxacin

Trial IDTitleStatusSponsorPhaseStart DateSummary
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.
>Trial ID>Title>Status>Phase>Start Date>Summary
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Clinical Trial Conditions for Levofloxacin

Condition Name

41880051015202530354045Helicobacter Pylori InfectionCataractTuberculosis[disabled in preview]
Condition Name for Levofloxacin
Intervention Trials
Helicobacter Pylori Infection 41
Cataract 8
Tuberculosis 8
[disabled in preview] 0
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Condition MeSH

63524500102030405060InfectionsInfectionCommunicable Diseases[disabled in preview]
Condition MeSH for Levofloxacin
Intervention Trials
Infections 63
Infection 52
Communicable Diseases 45
[disabled in preview] 0
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Clinical Trial Locations for Levofloxacin

Trials by Country

+
Trials by Country for Levofloxacin
Location Trials
United States 521
China 91
Italy 56
Canada 40
South Africa 31
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Trials by US State

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Trials by US State for Levofloxacin
Location Trials
Florida 29
California 29
Michigan 24
Texas 23
Pennsylvania 22
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Clinical Trial Progress for Levofloxacin

Clinical Trial Phase

49.5%45.1%5.5%00102030405060708090Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for Levofloxacin
Clinical Trial Phase Trials
Phase 4 90
Phase 3 82
Phase 2/Phase 3 10
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Clinical Trial Status

67.1%16.7%16.2%0020406080100120140160CompletedRecruitingUnknown status[disabled in preview]
Clinical Trial Status for Levofloxacin
Clinical Trial Phase Trials
Completed 157
Recruiting 39
Unknown status 38
[disabled in preview] 0
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Clinical Trial Sponsors for Levofloxacin

Sponsor Name

trials02468101214161820222426Johnson & Johnson Pharmaceutical Research & Development, L.L.C.PriCara, Unit of Ortho-McNeil, Inc.National Taiwan University Hospital[disabled in preview]
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 12
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Sponsor Type

71.8%25.6%0050100150200250300350400450OtherIndustryNIH[disabled in preview]
Sponsor Type for Levofloxacin
Sponsor Trials
Other 420
Industry 150
NIH 15
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Levofloxacin: Clinical Trials, Market Analysis, and Projections

Introduction

Levofloxacin, a fluoroquinolone antibiotic, has been a cornerstone in the treatment of various bacterial infections. Recent clinical trials and market analyses provide significant insights into its efficacy, safety, and market trends.

Clinical Trials Update

Prevention of Multidrug-Resistant Tuberculosis (MDR-TB)

Recent clinical trials have highlighted levofloxacin's efficacy in preventing MDR-TB. The TB-CHAMP and VQUIN trials, conducted in different populations, demonstrated that levofloxacin significantly reduces the risk of developing MDR-TB.

  • In the TB-CHAMP trial, involving 922 children and adolescents exposed to an adult with MDR-TB, levofloxacin reduced the risk of MDR-TB disease by 56%[1][4].
  • The VQUIN trial, conducted across 10 provinces in Vietnam and involving 2,041 adults and children, showed a 45% reduction in the risk of MDR-TB[1].

Combined analyses of these trials confirmed that levofloxacin is effective in preventing TB in both adults and children, with a overall reduction of 60% in the risk of developing MDR-TB. These findings are crucial for global health guidelines, especially as they inform new recommendations for MDR-TB preventative treatment by the World Health Organization[1].

Safety and Tolerability

The trials also emphasized the safety and tolerability of levofloxacin, particularly in children. The drug was associated with very few side effects, with joint pain and tendonitis being uncommon among participants[1][4].

Market Analysis

Global Market Trends

The levofloxacin market is projected to experience significant growth over the coming years.

  • The market is forecast to reach $1.9 billion by 2025, growing at a CAGR of 4.7% from 2020 to 2025[2].
  • Another projection suggests a CAGR of 5.1% by 2028, driven by the increasing burden of nosocomial and community-acquired pneumonia, as well as other bacterial infections[3].

Regional Market Performance

The market performance varies by region:

  • North America: This region accounts for a major share of the market, with 44% of the revenue. It is expected to maintain its position over the forecast period[2].
  • Asia Pacific (APAC): The APAC region is estimated to record the fastest growth rate due to the expansion of manufacturing pharmacies and increasing healthcare awareness[2][3].
  • China: Despite a decline in sales during the COVID-19 pandemic, the Chinese market is expected to experience restorative growth from 2021 to 2025, driven by the drug's broad antibacterial spectrum and strong antibacterial activity[5].

Market Drivers

Several factors are driving the growth of the levofloxacin market:

  • Increasing Incidence of Bacterial Infections: The rising number of bacterial infections, including pneumonia, urinary tract infections, and others, is a key driver[2][3].
  • Government Initiatives: Rising government initiatives aimed at improving awareness and treatment of infections are expected to aid market growth[2].
  • Healthcare Infrastructure: The expansion of hospitals and retail pharmacies is also contributing to the market's growth[2].

Impact of COVID-19

The COVID-19 pandemic had a mixed impact on the levofloxacin market:

  • Initially, there was a decrease in demand due to reduced hospital visits and resource reallocation. However, during the later phases of the pandemic, there was an increased demand for antibiotics, including levofloxacin, for the management of COVID-19-related infections[3][5].

Market Projections

Future Growth

The levofloxacin market is expected to continue growing due to several factors:

  • Pneumonia Segment: The pneumonia segment is anticipated to hold a significant share of the global levofloxacin market, driven by the increasing incidence of community-acquired and ventilator-associated bacterial pneumonias[3].
  • TB Burden: The high burden of tuberculosis across various regions, particularly in South-East Asia, Africa, and the Western Pacific, will also drive market growth[3].

Challenges

Despite the positive projections, there are challenges to market growth:

  • Lack of Awareness: Limited awareness about infectious diseases and their treatments is a significant barrier to market growth[3].
  • Side Effects and Resistance: Although levofloxacin has shown safety and efficacy, concerns about side effects and the potential for antimicrobial resistance remain[1].

Key Takeaways

  • Clinical Efficacy: Levofloxacin has been proven effective in preventing MDR-TB in both children and adults.
  • Market Growth: The levofloxacin market is projected to grow significantly, driven by increasing bacterial infections and government initiatives.
  • Regional Variations: The market performance varies by region, with APAC expected to show the fastest growth.
  • COVID-19 Impact: The pandemic had a mixed impact on the market, initially reducing demand but later increasing it due to COVID-19 management needs.
  • Future Prospects: The market is expected to continue growing, particularly in the pneumonia segment and in regions with a high TB burden.

FAQs

What is the primary use of levofloxacin in recent clinical trials?

Levofloxacin has been primarily used in recent clinical trials to prevent multidrug-resistant tuberculosis (MDR-TB) in individuals exposed to MDR-TB.

How effective is levofloxacin in preventing MDR-TB?

Levofloxacin has been shown to reduce the risk of developing MDR-TB by 56% in children and 45% in adults, with a combined reduction of 60% across both trials[1][4].

What are the key drivers of the levofloxacin market?

The key drivers include the increasing incidence of bacterial infections, government initiatives to improve healthcare awareness, and the expansion of healthcare infrastructure[2][3].

How did the COVID-19 pandemic impact the levofloxacin market?

The pandemic initially reduced demand due to decreased hospital visits but later increased demand as levofloxacin was used in the management of COVID-19-related infections[3][5].

Which region is expected to show the fastest growth in the levofloxacin market?

The Asia Pacific (APAC) region is expected to record the fastest growth rate due to the expansion of manufacturing pharmacies and increasing healthcare awareness[2][3].

Sources

  1. UCL News: "First effective treatment to prevent multidrug-resistant TB" - November 16, 2023
  2. IndustryArc: "Levofloxacin Market Share, Size and Industry Growth Analysis 2020"
  3. Mordor Intelligence: "Levofloxacin Market Size & Share Analysis"
  4. Bloomberg: "Children at Risk of Multidrug-Resistant TB Get Prevention Option" - December 18, 2024
  5. BusinessWire: "Investigation Report on China's Levofloxacin Market 2021-2025" - June 30, 2021

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