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Last Updated: March 20, 2025

CLINICAL TRIALS PROFILE FOR AMOXICILLIN; CLAVULANATE POTASSIUM


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All Clinical Trials for Amoxicillin; 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Amoxicillin; Clavulanate Potassium

Condition Name

Condition Name for Amoxicillin; Clavulanate Potassium
Intervention Trials
Sinusitis 4
Acute Otitis Media 2
Lymphoma 2
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Condition MeSH

Condition MeSH for Amoxicillin; Clavulanate Potassium
Intervention Trials
Sinusitis 5
Communicable Diseases 2
Pneumonia, Bacterial 2
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Clinical Trial Locations for Amoxicillin; Clavulanate Potassium

Trials by Country

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

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

Clinical Trial Phase

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

Sponsor Name

Sponsor Name for Amoxicillin; 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; 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 is a widely used antibiotic combination that has been a cornerstone in the treatment of various bacterial infections. This article delves into the current state of clinical trials, market analysis, and future projections for this medication.

Clinical Trials Update

Ongoing and Completed Trials

As of October 2024, there are 39 clinical trials involving clavulanic acid listed on clinicaltrials.gov, with 32 recruiting and seven active but not recruiting. These trials explore the use of clavulanic acid in combination with other drugs for various conditions, including surgical site infections, dental infections, and even non-traditional uses such as cocaine use disorder and obstetric perineal tear[3].

Efficacy and Safety Studies

A significant study published in the Clinical Infectious Diseases journal compared the efficacy and safety of amoxicillin/clavulanate administered every 12 hours versus every 8 hours in patients with lower respiratory tract infections. The results showed that both dosing regimens were equally effective and safe, with the 12-hour group reporting fewer instances of moderate or severe diarrhea[4].

Market Analysis

Current Market Size and Growth

The global Amoxicillin and Clavulanate Potassium market has witnessed substantial growth in recent years. In 2023, the market size was valued at several billion USD, and it is anticipated to continue growing significantly until 2031. The market is segmented by type (tablets, oral liquids) and application (hospitals, pharmacies), with North America, Europe, and the Asia-Pacific region being key contributors[2].

Regional Market Dynamics

  • North America: This region holds a significant market share due to the high incidence of antibiotic-resistant bacterial infections and a well-established healthcare infrastructure. The United States and Canada are major drivers of market growth[5].
  • Europe: Europe also has a substantial market share, characterized by advanced healthcare systems and high antibiotic consumption rates. Countries like Germany, the UK, France, and Italy are prominent markets[5].
  • Asia Pacific: This region is experiencing rapid growth due to population growth, urbanization, and improving access to healthcare services. Countries like China, India, and Japan are key markets[5].
  • Latin America and Middle East & Africa: These regions are also growing, driven by improving healthcare infrastructure and government initiatives to combat antibiotic resistance[5].

Market Segments

The market is categorized into several segments:

  • Hospital Pharmacy: Dominated the market in 2022 with a 46.31% share and is expected to grow at a CAGR of 3.09% during the forecast period[5].
  • Retail Pharmacy: Emerged as the second-largest segment in 2022 and is forecasted to grow at a CAGR of 2.64%[5].

Market Projections

Growth Rate and Future Value

The global Potassium Clavulanate market, which includes Amoxicillin and Clavulanate Potassium, is projected to grow at a CAGR of approximately 3% from 2024 to 2033. The market valuation is expected to increase from USD 789.72 million in 2024 to USD 950.77 million by 2033[5].

Drivers and Restraints

The market growth is driven by several factors:

  • Increasing Prevalence of Antibiotic-Resistant Bacterial Infections: The rising need for effective combination therapies is a significant driver[5].
  • Growing Demand for Combination Therapies: The enhanced effectiveness of antibiotics when combined with clavulanic acid is a key factor[5].
  • Improving Healthcare Infrastructure: Especially in regions like the Asia Pacific, where access to healthcare is expanding[5].

However, the market also faces restraints such as the potential for adverse reactions and the need for careful dosing to avoid complications like hepatic dysfunction and renal issues[1].

Key Takeaways

  • Clinical Trials: Ongoing trials are exploring new uses for clavulanic acid, including surgical site infections and non-traditional conditions.
  • Market Size and Growth: The global market for Amoxicillin and Clavulanate Potassium is expected to grow significantly until 2031.
  • Regional Dynamics: North America, Europe, and the Asia Pacific are key regions driving market growth.
  • Market Segments: Hospital pharmacies dominate the market, with retail pharmacies being the second-largest segment.
  • Future Projections: The market is projected to grow at a CAGR of approximately 3% from 2024 to 2033.

FAQs

What are the common dosing regimens for Amoxicillin and Clavulanate Potassium?

The dosing regimens vary based on the infection type and patient age. For example, for otitis media, sinusitis, and lower respiratory tract infections, the dosing can be 45 mg/kg/day every 12 hours or 40 mg/kg/day every 8 hours for pediatric patients[1].

What are the potential side effects of Amoxicillin and Clavulanate Potassium?

Potential side effects include hepatic dysfunction, interstitial nephritis, hematuria, crystalluria, and various hematologic and central nervous system reactions[1].

How does the combination of Amoxicillin and Clavulanate Potassium enhance antibiotic efficacy?

Clavulanic acid inhibits bacterial beta-lactamase enzymes, which are responsible for antibiotic resistance, thereby enhancing the effectiveness of amoxicillin[5].

What regions are expected to drive the growth of the Amoxicillin and Clavulanate Potassium market?

North America, Europe, and the Asia Pacific are expected to be the key drivers of market growth due to their healthcare infrastructure and the prevalence of antibiotic-resistant infections[2][5].

Are there any ongoing clinical trials for new uses of Clavulanate Potassium?

Yes, there are several ongoing clinical trials exploring the use of clavulanic acid in combination with other drugs for various conditions, including surgical site infections and non-traditional uses like cocaine use disorder[3].

Sources

  1. Drugs.com - Amoxicillin and Clavulanate Oral Suspension
  2. Market Research Intellect - Global Amoxicillin And Clavulanate Potassium Market
  3. Towards Healthcare - Clavulanic Acid Series API Market Size, Shares and Trends
  4. Clinical Infectious Diseases - Dosing of Amoxicillin/Clavulanate Given Every 12 Hours Is as Effective as Every-8-Hours Administration
  5. Custom Market Insights - Global Potassium Clavulanate Market Size, Trends, Share 2033

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