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Last Updated: March 27, 2025

CLINICAL TRIALS PROFILE FOR NITROFURAZONE


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All Clinical Trials for nitrofurazone

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT02099240 ↗ Patients Response to Early Switch To Oral:Osteomyelitis Study Terminated James Graham Brown Cancer Center Early Phase 1 2014-03-06 Based on the current literature, investigators hypothesize that patients with osteomyelitis who are treated with the standard approach of intravenous antibiotics for the full duration of therapy will have the same clinical outcomes as patients treated with the experimental approach of intravenous antibiotics with early switch to oral antibiotics. The primary objective of this study is to compare patients with osteomyelitis treated with the standard approach of intravenous antibiotics for the full duration of therapy versus patients treated with intravenous antibiotics with an early switch to oral antibiotics in relation to clinical outcomes at 12 months after discontinuation of antibiotic therapy. Secondary objectives of the study include the evaluation of adverse events related to the use of antibiotics as well as the cost of care evaluated from the hospital perspective.
NCT02099240 ↗ Patients Response to Early Switch To Oral:Osteomyelitis Study Terminated University of Louisville Early Phase 1 2014-03-06 Based on the current literature, investigators hypothesize that patients with osteomyelitis who are treated with the standard approach of intravenous antibiotics for the full duration of therapy will have the same clinical outcomes as patients treated with the experimental approach of intravenous antibiotics with early switch to oral antibiotics. The primary objective of this study is to compare patients with osteomyelitis treated with the standard approach of intravenous antibiotics for the full duration of therapy versus patients treated with intravenous antibiotics with an early switch to oral antibiotics in relation to clinical outcomes at 12 months after discontinuation of antibiotic therapy. Secondary objectives of the study include the evaluation of adverse events related to the use of antibiotics as well as the cost of care evaluated from the hospital perspective.
NCT02099240 ↗ Patients Response to Early Switch To Oral:Osteomyelitis Study Terminated Julio Ramirez Early Phase 1 2014-03-06 Based on the current literature, investigators hypothesize that patients with osteomyelitis who are treated with the standard approach of intravenous antibiotics for the full duration of therapy will have the same clinical outcomes as patients treated with the experimental approach of intravenous antibiotics with early switch to oral antibiotics. The primary objective of this study is to compare patients with osteomyelitis treated with the standard approach of intravenous antibiotics for the full duration of therapy versus patients treated with intravenous antibiotics with an early switch to oral antibiotics in relation to clinical outcomes at 12 months after discontinuation of antibiotic therapy. Secondary objectives of the study include the evaluation of adverse events related to the use of antibiotics as well as the cost of care evaluated from the hospital perspective.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 3 of 3 entries

Clinical Trial Conditions for nitrofurazone

Condition Name

10-0.100.10.20.30.40.50.60.70.80.911.1Osteomyelitis[disabled in preview]
Condition Name for nitrofurazone
Intervention Trials
Osteomyelitis 1
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Condition MeSH

10-0.100.10.20.30.40.50.60.70.80.911.1Osteomyelitis[disabled in preview]
Condition MeSH for nitrofurazone
Intervention Trials
Osteomyelitis 1
[disabled in preview] 0
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Clinical Trial Locations for nitrofurazone

Trials by Country

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Trials by Country for nitrofurazone
Location Trials
United States 1
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Trials by US State

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Trials by US State for nitrofurazone
Location Trials
Kentucky 1
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Clinical Trial Progress for nitrofurazone

Clinical Trial Phase

100.0%0-0.100.10.20.30.40.50.60.70.80.911.1Early Phase 1[disabled in preview]
Clinical Trial Phase for nitrofurazone
Clinical Trial Phase Trials
Early Phase 1 1
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Clinical Trial Status

100.0%0-0.100.10.20.30.40.50.60.70.80.911.1Terminated[disabled in preview]
Clinical Trial Status for nitrofurazone
Clinical Trial Phase Trials
Terminated 1
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Clinical Trial Sponsors for nitrofurazone

Sponsor Name

trials000001111111University of LouisvilleJulio RamirezJames Graham Brown Cancer Center[disabled in preview]
Sponsor Name for nitrofurazone
Sponsor Trials
University of Louisville 1
Julio Ramirez 1
James Graham Brown Cancer Center 1
[disabled in preview] 0
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Sponsor Type

100.0%000.511.522.53Other[disabled in preview]
Sponsor Type for nitrofurazone
Sponsor Trials
Other 3
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Nitrofurazone: Clinical Trials, Market Analysis, and Projections

Introduction

Nitrofurazone, a topical anti-infective agent, has been used for various medical applications, including the treatment of burns and the prevention of bacterial infections in surgical settings. This article will delve into the recent clinical trials, market analysis, and projections for nitrofurazone, providing a comprehensive overview of its current and future standing.

Clinical Trials: Efficacy and Safety

Urinary Catheter Trials

One of the notable clinical trials involving nitrofurazone is the comparison of nitrofurazone-coated silicone urinary catheters with non-impregnated silicone urinary catheters in kidney transplant recipients. This single-center, randomized controlled trial conducted at the Hospital do Rim in São Paulo, Brazil, aimed to assess the efficacy of nitrofurazone-coated catheters in reducing bacteriuria and urinary tract infections.

  • Results: The study involved 214 subjects, with 176 completing the trial. The results showed no significant differences in the rates of asymptomatic bacteriuria (12.5% in the nitrofurazone group vs. 11.4% in the control group) and urinary tract infections (8% vs. 6.8%). However, the incidence of side effects was more frequent in the nitrofurazone-impregnated group (46.6% vs. 26.1%)[1][4].

  • Conclusion: The study concluded that there is no beneficial effect of using nitrofurazone-coated urinary catheters, highlighting the need for alternative strategies to prevent urinary tract infections in kidney transplant recipients.

Mechanism of Action and Uses

Nitrofurazone is effective against both gram-negative and gram-positive bacteria by inhibiting several bacterial enzymes involved in glucose and pyruvate degradation. Here are its primary uses:

  • Topical Anti-Infective: Nitrofurazone is indicated as an adjunctive therapy for second and third-degree burns, especially when resistance to other agents is a concern. It is also used in skin grafting to prevent bacterial contamination[5].

Market Analysis

Current Market Status

The market for nitrofurazone is relatively niche, primarily focused on its use in topical applications for burns and surgical wound care. Given its limited scope, it does not dominate large market segments like those seen in oncology or other therapeutic areas.

Market Projections

There are no significant market projections specifically for nitrofurazone, as it is not a blockbuster drug. However, the broader market for antimicrobial agents and wound care products is expected to grow due to increasing concerns about antibiotic resistance and the need for effective infection control measures.

Comparison with Other Markets

To put the market for nitrofurazone into perspective, let's compare it with a more dynamic market like the Non-Small Cell Lung Cancer (NSCLC) market.

  • NSCLC Market: The NSCLC market is projected to grow significantly, with sales expected to reach $26.8 billion by 2025, driven by the adoption of premium-priced immune checkpoint inhibitors and targeted therapies. This market is characterized by high growth rates and significant market share shifts among major players[2].

In contrast, the market for nitrofurazone is much smaller and more stable, with no dramatic growth projections.

Challenges and Limitations

Side Effects and Efficacy

The clinical trials on nitrofurazone-coated urinary catheters highlighted a higher incidence of side effects without a corresponding reduction in infections. This suggests that while nitrofurazone may be effective in certain topical applications, its use in other areas may be limited by its side effect profile.

Resistance and Alternatives

The increasing concern about antibiotic resistance also poses a challenge for nitrofurazone. As bacteria develop resistance to various antimicrobial agents, the effectiveness of nitrofurazone may diminish, necessitating the development of alternative treatments.

Future Directions

Given the limitations and challenges associated with nitrofurazone, future research and development may focus on:

  • Combination Therapies: Exploring combination therapies that include nitrofurazone with other antimicrobial agents to enhance efficacy and reduce resistance.
  • New Formulations: Developing new formulations or delivery systems that minimize side effects and improve patient compliance.
  • Alternative Indications: Investigating other potential indications where nitrofurazone could be effective, such as in the treatment of other types of infections or in veterinary medicine.

Key Takeaways

  • Clinical Trials: Recent trials have shown no beneficial effect of using nitrofurazone-coated urinary catheters in preventing urinary tract infections in kidney transplant recipients.
  • Market Analysis: The market for nitrofurazone is niche and stable, with no significant growth projections.
  • Mechanism and Uses: Nitrofurazone is effective against gram-negative and gram-positive bacteria and is used primarily in topical applications for burns and surgical wound care.
  • Challenges: Higher incidence of side effects and the potential for antibiotic resistance are significant challenges.

FAQs

What is the primary use of nitrofurazone?

Nitrofurazone is primarily used as a topical anti-infective agent for treating second and third-degree burns and preventing bacterial contamination in skin grafting.

Did the clinical trial on nitrofurazone-coated urinary catheters show any benefits?

No, the clinical trial did not show any significant benefits in reducing bacteriuria or urinary tract infections with the use of nitrofurazone-coated urinary catheters compared to non-impregnated catheters.

What are the side effects associated with nitrofurazone-coated urinary catheters?

The incidence of side effects was more frequent in the nitrofurazone-impregnated group, with 46.6% of patients experiencing side effects compared to 26.1% in the control group.

How does the market for nitrofurazone compare to other pharmaceutical markets?

The market for nitrofurazone is much smaller and more stable compared to dynamic markets like the NSCLC market, which is expected to grow significantly due to the adoption of new therapies.

What are the future directions for nitrofurazone research and development?

Future research may focus on combination therapies, new formulations, and exploring alternative indications to enhance the efficacy and safety of nitrofurazone.

Sources

  1. Menezes et al. (2018). A randomized clinical trial comparing Nitrofurazone-coated and uncoated urinary catheters in kidney transplant recipients: Results from a pilot study. Journal of Transplantation, DOI: 10.1111/tid.13031.
  2. GlobalData. NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025. Drug Development & Delivery.
  3. Garcia-Estrada et al. (2023). Further Investigations of Nitroheterocyclic Compounds as Potential Therapeutic Agents. Digital CSIC.
  4. Menezes et al. (2018). A randomized clinical trial comparing Nitrofurazone‐coated and uncoated urinary catheters in kidney transplant recipients: Results from a pilot study. Transplant International, DOI: 10.1111/tid.13031.
  5. DrugBank. Nitrofural: Uses, Interactions, Mechanism of Action | DrugBank Online. DrugBank.

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