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Last Updated: February 7, 2025

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


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

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00035347 ↗ Intravenous Azithromycin Plus Intravenous Ceftriaxone Followed by Oral Azithromycin With Intravenous Levofloxacin Followed by Oral Levofloxacin for the Treatment of Moderate to Severely Ill Hospitalized Patients With Community Acquired Pneumonia Completed Pfizer Phase 4 2001-01-01 A trial in which patients over 18 years of age who are hospitalized with community acquired pneumonia and are otherwise eligible for entry into the study are randomly selected to receive one of two treatment regimens. After written informed consent is obtained, patients will receive one of the following two treatment regimens: 1) intravenous administration of azithromycin and ceftriaxone followed by azithromycin tablets, or 2) intravenous administration of levofloxacin followed by levofloxacin tablets. At least four study visits are normally conducted up to approximately one month after starting therapy. The objective of this study is to compare the safety and efficacy of the two treatment regimens.
NCT00176306 ↗ Levofloxacin Pharmacokinetics (PK) in the Severely Obese Completed Ortho-McNeil Pharmaceutical Phase 4 2005-01-01 Obesity is known to affect the concentrations of certain medications in the body. Levofloxacin is a commonly used antibiotic. Based on what the investigators know about levofloxacin and how it moves through the body, obesity may affect levofloxacin concentrations. This study aims to show the effect of obesity on levofloxacin concentrations. The hypothesis is as follows: A 750 mg intravenous (IV) dose of levofloxacin administered to severely obese, critically ill patients will yield serum concentrations that are likely to be therapeutic.
NCT00176306 ↗ Levofloxacin Pharmacokinetics (PK) in the Severely Obese Completed Joel Thompson, PhD Phase 4 2005-01-01 Obesity is known to affect the concentrations of certain medications in the body. Levofloxacin is a commonly used antibiotic. Based on what the investigators know about levofloxacin and how it moves through the body, obesity may affect levofloxacin concentrations. This study aims to show the effect of obesity on levofloxacin concentrations. The hypothesis is as follows: A 750 mg intravenous (IV) dose of levofloxacin administered to severely obese, critically ill patients will yield serum concentrations that are likely to be therapeutic.
NCT00176306 ↗ Levofloxacin Pharmacokinetics (PK) in the Severely Obese Completed University of Kentucky Phase 4 2005-01-01 Obesity is known to affect the concentrations of certain medications in the body. Levofloxacin is a commonly used antibiotic. Based on what the investigators know about levofloxacin and how it moves through the body, obesity may affect levofloxacin concentrations. This study aims to show the effect of obesity on levofloxacin concentrations. The hypothesis is as follows: A 750 mg intravenous (IV) dose of levofloxacin administered to severely obese, critically ill patients will yield serum concentrations that are likely to be therapeutic.
NCT00250718 ↗ Study: Treatment of Relapsed Lymphoid Malignancies With an Anti-Angiogenic Approach Terminated New Mexico Cancer Care Alliance Phase 2 2004-10-01 1.1 To determine the efficacy of a combination treatment of VP-16, chlorambucil, dexamethasone, and vincristine in patients with relapsed/refractory hematological malignancies. 1.2 To determine the toxicity profile of the above regimen in this patient population. 1.3 Evaluate the effect of low dose administration of chemotherapy on angiogenesis, and correlate this with tumor responses.
NCT00617591 ↗ Pegylated Liposomal Doxorubicin, Low Freq Dexamethasone & Revlimid (Dd-R) in Newly Diagnosed Multiple Myeloma (MM) Completed Celgene Corporation Phase 2 2008-01-01 The purpose of the research study is to determine the response rates when Revlimid® is combined with Doxil® and Dexamethasone (Dd-R) in newly diagnosed Multiple Myeloma. The study will also evaluate the side effects caused by the combination of these three drugs. This therapy is investigational in the treatment of Multiple Myeloma. Revlimid® is a drug that alters the immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. Revlimid® is approved by the Food and Drug Administration (FDA) for specific types of myelodysplastic syndrome (MDS) and Multiple Myeloma, two different types of blood cancer. It is currently being tested in a variety of other cancer conditions. In this case it is considered experimental. Doxil® is a form of chemotherapy. It is approved by the FDA for the treatment of relapsed/ refractory Multiple Myeloma in combination with Velcade. Dexamethasone is a steroid. It is also approved by the FDA, but not for the treatment of Multiple Myeloma. It is considered a standard part of most myeloma therapies for newly diagnosed patients.
NCT00617591 ↗ Pegylated Liposomal Doxorubicin, Low Freq Dexamethasone & Revlimid (Dd-R) in Newly Diagnosed Multiple Myeloma (MM) Completed Ortho Biotech Clinical Affairs, L.L.C. Phase 2 2008-01-01 The purpose of the research study is to determine the response rates when Revlimid® is combined with Doxil® and Dexamethasone (Dd-R) in newly diagnosed Multiple Myeloma. The study will also evaluate the side effects caused by the combination of these three drugs. This therapy is investigational in the treatment of Multiple Myeloma. Revlimid® is a drug that alters the immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. Revlimid® is approved by the Food and Drug Administration (FDA) for specific types of myelodysplastic syndrome (MDS) and Multiple Myeloma, two different types of blood cancer. It is currently being tested in a variety of other cancer conditions. In this case it is considered experimental. Doxil® is a form of chemotherapy. It is approved by the FDA for the treatment of relapsed/ refractory Multiple Myeloma in combination with Velcade. Dexamethasone is a steroid. It is also approved by the FDA, but not for the treatment of Multiple Myeloma. It is considered a standard part of most myeloma therapies for newly diagnosed patients.
>Trial ID >Title >Status >Phase >Start Date >Summary

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

Condition Name

Condition Name for Levaquin In Dextrose 5% In Plastic Container
Intervention Trials
Multiple Sclerosis 1
Bladder Carcinoma 1
Recurrent Childhood Acute Lymphoblastic Leukemia 1
Urinary Tract Infections 1
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Condition MeSH

Condition MeSH for Levaquin In Dextrose 5% In Plastic Container
Intervention Trials
Tuberculosis 4
Infections 4
Infection 4
Pneumonia 4
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Clinical Trial Locations for Levaquin In Dextrose 5% In Plastic Container

Trials by Country

Trials by Country for Levaquin In Dextrose 5% In Plastic Container
Location Trials
United States 127
Canada 13
Georgia 4
India 3
Moldova, Republic of 3
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Trials by US State

Trials by US State for Levaquin In Dextrose 5% In Plastic Container
Location Trials
Florida 7
California 7
Texas 6
Ohio 6
New York 6
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Clinical Trial Progress for Levaquin In Dextrose 5% In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Levaquin In Dextrose 5% In Plastic Container
Clinical Trial Phase Trials
Phase 4 7
Phase 3 6
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Levaquin In Dextrose 5% In Plastic Container
Clinical Trial Phase Trials
Completed 15
Terminated 3
Unknown status 2
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Clinical Trial Sponsors for Levaquin In Dextrose 5% In Plastic Container

Sponsor Name

Sponsor Name for Levaquin In Dextrose 5% In Plastic Container
Sponsor Trials
Tetraphase Pharmaceuticals, Inc. 2
Pfizer 2
Westat 2
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Sponsor Type

Sponsor Type for Levaquin In Dextrose 5% In Plastic Container
Sponsor Trials
Other 33
Industry 16
NIH 5
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Levofloxacin in 5% Dextrose Injection: Clinical Trials, Market Analysis, and Projections

Introduction to Levofloxacin

Levofloxacin is a synthetic broad-spectrum antibacterial agent belonging to the fluoroquinolone class. It is widely used for treating various bacterial infections in adults, particularly those caused by susceptible strains of designated microorganisms[2][3][4].

Clinical Trials and Efficacy

Clinical trials have consistently demonstrated the efficacy of levofloxacin in treating a range of infections, including upper respiratory tract infections, skin and skin structure infections, and urinary tract infections. These trials have shown that levofloxacin is effective against a broad spectrum of bacteria, including both Gram-positive and Gram-negative organisms.

Key Findings

  • Bacterial Resistance: Studies have highlighted the importance of monitoring bacterial resistance, as some strains, such as Pseudomonas aeruginosa, can develop resistance during treatment[3].
  • Dosage and Administration: Clinical trials support the use of levofloxacin in 5% dextrose injection as an intravenous formulation, especially when oral administration is not feasible. The intravenous and oral formulations are interchangeable, but intravenous administration is recommended when it offers a clinical advantage[3].
  • Safety Profile: While generally well-tolerated, levofloxacin can cause side effects such as nausea, headache, and dizziness. Serious adverse reactions, including hypersensitivity reactions and tendonitis, have also been reported[2][3].

Market Analysis

Current Market Status

Levofloxacin in 5% dextrose injection is a widely prescribed antibiotic, particularly in hospital settings where intravenous administration is necessary. The market for this drug is driven by its broad-spectrum activity and the convenience of its premixed, ready-to-use formulation in flexible containers.

Market Players

Several pharmaceutical companies, including Pfizer and AuroMedics Pharma LLC, manufacture and distribute levofloxacin in 5% dextrose injection. These companies play a significant role in ensuring the availability and quality of the product[2][5].

Challenges and Recalls

Despite its widespread use, the market has faced challenges such as product recalls. For instance, AuroMedics Pharma LLC issued a voluntary recall of one lot of levofloxacin in 5% dextrose injection due to the presence of visible particulate matter, which could result in fatal infections if the product is non-sterile[5].

Market Projections

Growth Drivers

  • Increasing Demand for Broad-Spectrum Antibiotics: The rising incidence of bacterial infections and the need for effective treatments are expected to drive the demand for levofloxacin.
  • Advancements in Formulation: The convenience and safety of premixed, single-use flexible containers are likely to continue driving market growth.
  • Expanding Indications: Ongoing research may expand the indications for levofloxacin, further increasing its market share.

Market Trends

  • Generic Competition: The entry of generic versions of levofloxacin could impact the market share of branded products, although the convenience and reliability of branded formulations may help maintain their position.
  • Regulatory Environment: Strict regulatory oversight, particularly regarding product quality and sterility, will continue to influence the market.

Projected Market Size

The global market for fluoroquinolone antibiotics, including levofloxacin, is expected to grow significantly over the next few years. This growth is anticipated to be driven by increasing demand in both developed and emerging markets.

Preparation and Administration

Instructions for Use

Levofloxacin in 5% dextrose injection is supplied in premixed, ready-to-use flexible containers. Here are key steps for its preparation and administration:

  • Visual Inspection: Check the solution for clarity, discoloration, particulate matter, and leakage before use[3].
  • Container Integrity: Ensure the container is intact and free from leaks[3].
  • Administration: Use sterile equipment and follow the specific instructions for connecting the administration set and regulating the infusion rate[3].

Safety and Precautions

Contraindications

Levofloxacin is contraindicated in patients with known hypersensitivity to levofloxacin or other quinolone antibacterials[2][3].

Warnings

  • Bacterial Resistance: Monitor for the development of bacterial resistance during treatment[3].
  • Hypersensitivity Reactions: Be aware of the risk of severe hypersensitivity reactions, including anaphylaxis[2][3].
  • Tendonitis and Tendon Rupture: Fluoroquinolones, including levofloxacin, have been associated with an increased risk of tendonitis and tendon rupture[2][3].

Key Takeaways

  • Efficacy: Levofloxacin in 5% dextrose injection is effective against a broad spectrum of bacterial infections.
  • Market Demand: The market is driven by the need for broad-spectrum antibiotics and the convenience of premixed formulations.
  • Safety: While generally safe, levofloxacin requires careful monitoring for bacterial resistance and hypersensitivity reactions.
  • Regulatory Compliance: Manufacturers must adhere to strict regulatory standards to ensure product quality and sterility.

FAQs

Q: What is levofloxacin in 5% dextrose injection used for?

A: Levofloxacin in 5% dextrose injection is used to treat various bacterial infections in adults, including upper respiratory tract infections, skin and skin structure infections, and urinary tract infections.

Q: How is levofloxacin in 5% dextrose injection administered?

A: It is administered intravenously using premixed, ready-to-use flexible containers. The solution should be visually inspected for clarity and integrity before use.

Q: What are the common side effects of levofloxacin?

A: Common side effects include nausea, headache, and dizziness. Serious side effects can include hypersensitivity reactions and tendonitis.

Q: Can levofloxacin be used in children?

A: No, the safety and effectiveness of levofloxacin in children under 18 years of age have not been established.

Q: What should be done if a dose of levofloxacin is missed?

A: More than the prescribed dose should not be taken, even if a dose is missed. Patients should follow the prescribed dosage regimen strictly.

Sources

  1. LEVAQUIN Tablets/Injection - accessdata.fda.gov
  2. Levofloxacin in 5% Dextrose Injection, USP - Pfizer Medical Information
  3. Levofloxacin - Product Monograph Template - Standard - hres.ca
  4. Levofloxacin in 5% Dextrose Injection, USP Description - Pfizer Medical Information
  5. AuroMedics Pharma LLC Issues Voluntary Nationwide Recall - FDA.gov

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