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Last Updated: February 10, 2025

CLINICAL TRIALS PROFILE FOR AMOXICILLIN AND CLAVULANATE POTASSIUM


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All Clinical Trials for Amoxicillin And Clavulanate Potassium

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00002149 ↗ Acupuncture and Herbal Treatment of Chronic HIV Sinusitis Completed Immune Enhancement Project N/A 1969-12-31 To compare Traditional Chinese Medicine versus standard antibiotic therapy consisting of pseudoephedrine ( Sudafed ) plus amoxicillin / clavulanate potassium combination ( Augmentin ) in reducing symptoms and recurrence of acute HIV-related sinusitis. Chronic sinusitis in HIV-infected individuals is a recurrent and persistent infection with potentially serious complications: it can exacerbate pulmonary disease, cause recurrences of life-threatening sepsis, and progress to central nervous system involvement. Symptoms of sinusitis in HIV patients are often refractory to aggressive Western medical management, and antibiotic intolerance can occur. Traditional Chinese Medicine consisting of acupuncture and herbal treatment may provide a low-risk, low-cost alternative to conventional antibiotic therapy.
NCT00062231 ↗ Moxifloxacin Compared With Ciprofloxacin/Amoxicillin in Treating Fever and Neutropenia in Patients With Cancer Terminated European Organisation for Research and Treatment of Cancer - EORTC N/A 2002-04-01 RATIONALE: Antibiotics such as amoxicillin, ciprofloxacin, and moxifloxacin may be effective in preventing or controlling fever and neutropenia in patients with cancer. It is not yet known whether moxifloxacin alone is more effective than amoxicillin combined with ciprofloxacin in treating neutropenia and fever. PURPOSE: This randomized clinical trial is studying how well moxifloxacin works and compares it to ciprofloxacin together with amoxicillin in treating neutropenia and fever in patients with cancer.
NCT00132275 ↗ Guidelines for Acute Sinusitis Completed Thrasher Research Fund N/A 2003-11-01 Viral upper respiratory infections occur frequently during childhood (6-8 per year) and are, for the most part, self-limited episodes that resolve spontaneously and do not require antibiotic therapy. Acute otitis media and acute bacterial sinusitis are frequent complications of viral upper respiratory infections that will benefit from treatment with antibiotics. Acute bacterial sinusitis is one of the most common diagnoses in ambulatory practice and, in all age groups, accounts for an estimated 25 million physician office visits annually. It is essential to distinguish between patients who are experiencing uncomplicated viral upper respiratory infections and acute bacterial sinusitis to avoid the excessive use of antibiotics for patients who will not benefit from them. This is especially important now because of the escalation of antibiotic resistance among the bacteria that commonly cause acute bacterial sinusitis, acute otitis media and pneumonia. Inappropriate use of antibiotics is a major contributor to the problem of antimicrobial resistance - a problem which dramatically increases both the cost and complexity of treatment. To improve the diagnosis and treatment of patients with acute bacterial sinusitis and reduce the inappropriate use of antibiotics, clinical guidelines have been developed by three national organizations: the American Academy of Pediatrics, the Sinus and Allergy Health Partnership and the Centers for Disease Control and Prevention. Traditionally, the diagnosis of acute bacterial sinusitis is suspected on the basis of clinical signs and symptoms and is confirmed with the performance of images (either plain radiographs, computed tomography or magnetic resonance imaging). All three guidelines recommend that the diagnosis and treatment of acute bacterial sinusitis should be based on clinical criteria alone without the confirmation of imaging or other laboratory data. Although the similarity between the different guidelines suggests that there is widespread consensus to use clinical criteria to diagnose acute bacterial sinusitis, there is virtually no evidence to support this position. Specific Aim 1 of this project is to evaluate the use of clinical criteria, without the performance of images, as the basis for the diagnosis of acute bacterial sinusitis. A randomized, placebo-controlled study design will be used to determine if the clinical criteria proposed by the different guidelines can be used to identify children with upper respiratory symptoms who will respond to antibiotic therapy. It is expected that children with acute bacterial sinusitis who receive an antimicrobial will recover more quickly and more often than children who receive placebo.
NCT00132275 ↗ Guidelines for Acute Sinusitis Completed University of Pittsburgh N/A 2003-11-01 Viral upper respiratory infections occur frequently during childhood (6-8 per year) and are, for the most part, self-limited episodes that resolve spontaneously and do not require antibiotic therapy. Acute otitis media and acute bacterial sinusitis are frequent complications of viral upper respiratory infections that will benefit from treatment with antibiotics. Acute bacterial sinusitis is one of the most common diagnoses in ambulatory practice and, in all age groups, accounts for an estimated 25 million physician office visits annually. It is essential to distinguish between patients who are experiencing uncomplicated viral upper respiratory infections and acute bacterial sinusitis to avoid the excessive use of antibiotics for patients who will not benefit from them. This is especially important now because of the escalation of antibiotic resistance among the bacteria that commonly cause acute bacterial sinusitis, acute otitis media and pneumonia. Inappropriate use of antibiotics is a major contributor to the problem of antimicrobial resistance - a problem which dramatically increases both the cost and complexity of treatment. To improve the diagnosis and treatment of patients with acute bacterial sinusitis and reduce the inappropriate use of antibiotics, clinical guidelines have been developed by three national organizations: the American Academy of Pediatrics, the Sinus and Allergy Health Partnership and the Centers for Disease Control and Prevention. Traditionally, the diagnosis of acute bacterial sinusitis is suspected on the basis of clinical signs and symptoms and is confirmed with the performance of images (either plain radiographs, computed tomography or magnetic resonance imaging). All three guidelines recommend that the diagnosis and treatment of acute bacterial sinusitis should be based on clinical criteria alone without the confirmation of imaging or other laboratory data. Although the similarity between the different guidelines suggests that there is widespread consensus to use clinical criteria to diagnose acute bacterial sinusitis, there is virtually no evidence to support this position. Specific Aim 1 of this project is to evaluate the use of clinical criteria, without the performance of images, as the basis for the diagnosis of acute bacterial sinusitis. A randomized, placebo-controlled study design will be used to determine if the clinical criteria proposed by the different guidelines can be used to identify children with upper respiratory symptoms who will respond to antibiotic therapy. It is expected that children with acute bacterial sinusitis who receive an antimicrobial will recover more quickly and more often than children who receive placebo.
NCT00135603 ↗ Antibiotic Therapy Versus Appendectomy for Acute Appendicitis Completed Assistance Publique - Hôpitaux de Paris N/A 2004-02-01 The purpose of the study is to demonstrate that antibiotic therapy is as safe and effective as appendectomy for the treatment of acute non complicated appendicitis. Two hundred fifty patients will be included in a prospective multicentric randomized trial. The primary endpoint is the rate of intra abdominal infections in both therapeutic strategies. Other criteria will be studied including duration of hospital stay and absence from work during a follow up period of one year, parietal and abdominal complications and recurrent appendicitis after antibiotic therapy.
NCT00249210 ↗ A Study of the Safety and Effectiveness of Levofloxacin Compared With Amoxicillin/Clavulanate Potassium in the Treatment of Adults With Rapid Onset of Severe Inflammation/Infection of the Sinuses Completed PriCara, Unit of Ortho-McNeil, Inc. Phase 3 1993-08-01 The purpose of this study is to evaluate the safety and effectiveness of levofloxacin, an antibiotic, compared with amoxicillin/clavulanate potassium in the treatment of adults with rapid onset of severe inflammation/infection of the sinuses.
NCT00249210 ↗ A Study of the Safety and Effectiveness of Levofloxacin Compared With Amoxicillin/Clavulanate Potassium in the Treatment of Adults With Rapid Onset of Severe Inflammation/Infection of the Sinuses Completed Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Phase 3 1993-08-01 The purpose of this study is to evaluate the safety and effectiveness of levofloxacin, an antibiotic, compared with amoxicillin/clavulanate potassium in the treatment of adults with rapid onset of severe inflammation/infection of the sinuses.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Amoxicillin And Clavulanate Potassium

Condition Name

Condition Name for Amoxicillin And Clavulanate Potassium
Intervention Trials
Sinusitis 4
Pneumonia, Bacterial 2
Acute Otitis Media 2
Lymphoma 2
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Condition MeSH

Condition MeSH for Amoxicillin And Clavulanate Potassium
Intervention Trials
Sinusitis 5
Pneumonia, Bacterial 2
Pneumonia 2
Neutropenia 2
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Clinical Trial Locations for Amoxicillin And Clavulanate Potassium

Trials by Country

Trials by Country for Amoxicillin And Clavulanate Potassium
Location Trials
United States 27
Poland 4
Argentina 3
Panama 3
United Kingdom 3
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Trials by US State

Trials by US State for Amoxicillin And Clavulanate Potassium
Location Trials
Pennsylvania 5
California 4
Arkansas 3
Ohio 3
Utah 2
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Clinical Trial Progress for Amoxicillin And Clavulanate Potassium

Clinical Trial Phase

Clinical Trial Phase for Amoxicillin And Clavulanate Potassium
Clinical Trial Phase Trials
Phase 4 2
Phase 3 7
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Amoxicillin And Clavulanate Potassium
Clinical Trial Phase Trials
Completed 11
Terminated 4
Unknown status 2
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Clinical Trial Sponsors for Amoxicillin And Clavulanate Potassium

Sponsor Name

Sponsor Name for Amoxicillin And Clavulanate Potassium
Sponsor Trials
Pfizer 3
Teva Pharmaceuticals USA 2
Janssen Research & Development, LLC 2
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Sponsor Type

Sponsor Type for Amoxicillin And Clavulanate Potassium
Sponsor Trials
Other 15
Industry 10
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Amoxicillin and Clavulanate Potassium: Clinical Trials, Market Analysis, and Projections

Introduction

Amoxicillin and clavulanate potassium, a combination of the antibiotic amoxicillin and the beta-lactamase inhibitor clavulanic acid, is a widely used medication for treating various bacterial infections. This article delves into the current state of clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Ongoing and Completed Trials

As of October 2024, there are 39 clinical trials involving clavulanic acid listed on clinicaltrials.gov. Out of these, 32 are recruiting participants, and seven are active but not recruiting. These trials cover a broad range of applications, including the treatment of surgical site infections in pediatric uncomplicated appendectomy, dental infections, surgical site infections in colorectal surgery, and even the treatment of cocaine use disorder and obstetric perineal tear[4].

Specific Studies and Outcomes

One notable study involves the use of bismuth quadruple therapy with amoxicillin-clavulanate and tetracycline for the eradication of H. pylori. However, this combination has shown limited efficacy, with a 17.4% eradication rate by per-protocol analyses, highlighting the need for more effective treatment protocols[1].

Regional Focus

Clinical trials involving clavulanic acid are being conducted globally, with a significant number in the U.S. and Canada. In 2022, amoxicillin/clavulanic acid was the 96th most commonly prescribed medication in the U.S., with over 6 million prescriptions, indicating its widespread use[4].

Mechanism of Action and Therapeutic Areas

Beta-Lactamase Inhibition

Clavulanic acid acts as a potent inhibitor of many beta-lactamases, enzymes produced by bacteria that can render beta-lactam antibiotics ineffective. By inhibiting these enzymes, clavulanic acid protects the antibiotic amoxicillin from hydrolysis, allowing it to effectively target and kill bacteria[1].

Therapeutic Indications

Amoxicillin and clavulanate potassium are used to treat a variety of bacterial infections, including respiratory tract infections, skin and skin structure infections, and urinary tract infections. The combination is particularly effective against bacteria that produce beta-lactamases, which would otherwise be resistant to amoxicillin alone[5].

Market Analysis

Current Market Size and Growth

The global market for amoxicillin and clavulanate potassium has witnessed significant growth in recent years. As of 2023, the market size was valued in billions of USD, and it is projected to continue growing substantially until 2031. The market is segmented by type (tablets, oral liquids) and application (hospitals, pharmacies), with geographical regions such as North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa contributing to the overall growth[2].

Market Dynamics

The market dynamics are influenced by several factors, including drivers such as increasing bacterial resistance to antibiotics, the need for effective combination therapies, and growing healthcare expenditures. However, restraints like potential side effects, such as drug-induced liver damage, and the misuse of antibiotics also play a crucial role in shaping the market[2].

Regional Growth

The Asia-Pacific region is anticipated to be the fastest-growing market for clavulanic acid series APIs, driven by increasing healthcare needs and investments in healthcare infrastructure. This growth is expected to contribute significantly to the overall market expansion[4].

Market Projections

Forecasted Growth

The amoxicillin and clavulanate potassium market is projected to continue its upward trajectory from 2023 to 2031. The compound annual growth rate (CAGR) is expected to be significant, driven by the increasing demand for effective antibiotic treatments and the ongoing research and development in this area[2].

Revenue Outlook

The market is expected to reach a substantial value in USD billion by the end of the forecast period. This growth will be fueled by the expanding use of amoxicillin and clavulanate potassium in various therapeutic areas and the increasing adoption in different geographical regions[3].

Challenges and Opportunities

Challenges

One of the significant challenges facing the market is the potential for drug-induced liver damage, particularly when clavulanate potassium is used in high doses. Additionally, the misuse of antibiotics and the emergence of antibiotic-resistant bacteria pose ongoing challenges to the efficacy of this medication[1].

Opportunities

The growing number of clinical trials and the exploration of new therapeutic areas offer significant opportunities for the expansion of the amoxicillin and clavulanate potassium market. The increasing focus on combating antibiotic resistance and the development of new combination therapies are also expected to drive market growth[4].

Key Takeaways

  • Clinical Trials: Amoxicillin and clavulanate potassium are involved in numerous clinical trials, exploring new therapeutic areas and improving treatment outcomes.
  • Market Growth: The global market for this drug is projected to grow significantly from 2023 to 2031, driven by increasing demand and ongoing research.
  • Mechanism of Action: The combination works by inhibiting beta-lactamases, allowing amoxicillin to effectively target bacteria.
  • Therapeutic Areas: It is used to treat a variety of bacterial infections, including respiratory, skin, and urinary tract infections.
  • Challenges: Potential side effects and antibiotic resistance are key challenges that need to be addressed.

FAQs

What is the primary mechanism of action of clavulanic acid in amoxicillin and clavulanate potassium?

Clavulanic acid acts as a beta-lactamase inhibitor, protecting amoxicillin from hydrolysis by bacterial enzymes, thereby enhancing its antibacterial efficacy[1].

What are the common therapeutic indications for amoxicillin and clavulanate potassium?

This combination is used to treat various bacterial infections, including respiratory tract infections, skin and skin structure infections, and urinary tract infections[5].

What are the potential side effects of using amoxicillin and clavulanate potassium?

Potential side effects include drug-induced liver damage, especially when used in high doses, and other common side effects associated with antibiotic use[1].

How is the market for amoxicillin and clavulanate potassium expected to grow in the coming years?

The market is projected to grow significantly from 2023 to 2031, driven by increasing demand for effective antibiotic treatments and ongoing research and development[2].

Which region is expected to be the fastest-growing market for clavulanic acid series APIs?

The Asia-Pacific region is anticipated to be the fastest-growing market, driven by increasing healthcare needs and investments in healthcare infrastructure[4].

Sources

  1. Taylor and Francis: Clavulanate potassium – Knowledge and References
  2. Market Research Intellect: Global Amoxicillin And Clavulanate Potassium Market Size, Scope ...
  3. Market Research Reports: Amoxicillin Clavulanate Potassium Dispersible Tablets - Global Market Share and Ranking, Overall Sales and Demand Forecast 2024-2030
  4. Towards Healthcare: Clavulanic Acid Series API Market Size, Shares and Trends
  5. Synapse Patsnap: Amoxicillin/Clavulanate Potassium - Drug Targets, Indications, Patents

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