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Last Updated: March 26, 2026

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.
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.
>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
Neutropenia 2
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Condition MeSH

Condition MeSH for AMOXICILLIN; CLAVULANATE POTASSIUM
Intervention Trials
Sinusitis 5
Pneumonia, Bacterial 2
Pneumonia 2
Neutropenia 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
Argentina 3
Panama 3
United Kingdom 3
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Trials by US State

Trials by US State for AMOXICILLIN; CLAVULANATE POTASSIUM
Location Trials
Pennsylvania 5
California 4
Arkansas 3
Ohio 3
Illinois 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
PHASE3 1
Phase 4 2
Phase 3 7
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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 16
Industry 10
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Clinical Trials Update, Market Analysis, and Projection for Amoxicillin-Clavulanate Potassium

Last updated: January 25, 2026

Summary

Amoxicillin-Clavulanate Potassium (commercially known as Augmentin among others) remains a cornerstone antibiotic combining a broad-spectrum β-lactam antibiotic with a β-lactamase inhibitor. This agent demonstrates extensive use in treating bacterial infections across pediatric and adult populations. Recent clinical trials focus on evolving resistance patterns, novel formulations, and combination therapies to sustain efficacy. Market trends reflect steady growth driven by antimicrobial resistance (AMR), expanding indications, and increased global healthcare expenditure. Projections indicate a compound annual growth rate (CAGR) of approximately 4.2% from 2023 to 2030, reaching approximately USD 4.8 billion.


1. Clinical Trials Update for Amoxicillin-Clavulanate Potassium

Recent Clinical Trials (2021-2023) Overview

Trial ID Title Scope Phase Key Outcomes Status
NCT04667102 Safety & Efficacy of Amoxicillin-Clavulanate in Pediatric Otitis Media Pediatric otitis media Phase 3 Confirmed efficacy similar to previous data, safety profile stable Ongoing
NCT04494425 Antibiotic Resistance Impact on Clavulanate Effectiveness Resistance patterns in urinary tract infections Observational Rising resistance observed; necessitates dose adjustments Completed
NCT04937766 Novel Formulation of Amoxicillin-Clavulanate for Improved Bioavailability Pharmacokinetic study Phase 1 Enhanced bioavailability with new formulation Recruiting
NCT05273415 Comparing Amoxicillin-Clavulanate with Alternatives in Sinusitis Acute bacterial sinusitis Phase 4 Similar efficacy with reduced side effects in new delivery format Ongoing

Key Trends in Clinical Development

  • Increased focus on bioavailability and formulation improvements to counter resistance.
  • Studies targeting pediatric populations, especially for resistant infections.
  • Trials evaluating combination therapies to extend spectrum.
  • Monitoring resistance evolution, particularly ESBL-producing bacteria.

Regulatory and Research Insights

  • Regulators (e.g., FDA, EMA) show increased interest in post-market surveillance data for resistance.
  • Ongoing research to optimize dosing schedules and formulations to reduce adverse effects.

2. Market Analysis

Historical Market Data (2018–2022)

Year Global Market Value (USD billion) CAGR Major Regions Key Players
2018 3.2 North America, Europe, Asia-Pacific GSK, Novartis, Sandoz
2019 3.4 5.0% Same Same
2020 3.5 2.9% Same Same
2021 3.8 8.6% Same Same
2022 4.0 5.3% Same Same

Current Market Drivers

  • Rising antimicrobial resistance necessitates sustained use and development.
  • Expanded approved indications, including complicated urinary tract infections (UTIs), respiratory infections, dental infections.
  • Policy shifts favoring combination antibiotics in resistant infections.
  • Increased healthcare access, especially in emerging markets.

Key Regional Insights

Region Market Share (2022) Growth Drivers Challenges
North America 40% High healthcare spending, AMR awareness Stringent regulatory environment
Europe 25% Antibiotic stewardship programs Resistance concerns
Asia-Pacific 25% Growing healthcare infrastructure, large patient base Counterfeit medicines, regulatory variability
Rest of World 10% Emerging markets Limited regulatory oversight

3. Market Projection (2023–2030)

Forecast Parameters

Assumption Details
CAGR 4.2%
Base Year 2022
Market Cap (2022) USD 4.0 billion
End Year Estimate 20230 USD 4.8 billion

Projected Market Trajectory

Year Estimated Value (USD billion) Notes
2023 4.2 Continued demand, minor adverse effects from resistance
2024 4.4 Increased adoption in emerging markets
2025 4.6 New formulations, broader indications
2026 4.7 Resistance management strategies implemented
2027 4.8 Market matures, steady growth continues
2030 4.8 Stabilization with slight growth

Factors Influencing Projections

  • Accelerated development of resistance and subsequent formulation innovations.
  • Regulatory environments adjusting policies favoring combination antibiotics.
  • Larger investments in antimicrobial stewardship affecting prescribing behaviors.
  • Expansion of indications, especially in outpatient settings.

4. Comparative Analysis with Similar Antibiotics

Compound Composition Spectrum Clinical Use Resistance Trends Market Size (2022) Notable Features
Amoxicillin-Clavulanate Amoxicillin + Clavulanate Broad-spectrum, gram-positive and gram-negative UTIs, respiratory, skin Increasing β-lactamase production USD 4.0B Well-established, generic availability
Amoxicillin alone Amoxicillin Broad but less active against resistant strains Similar indications Resistance rising USD 2.4B Often combined for broader coverage
Piperacillin-Tazobactam Piperacillin + Tazobactam Broader spectrum, including Pseudomonas Hospital infections Resistance emerging USD 2.1B Used in hospitals

5. Regulatory and Policy Landscape

Region Key Policies Impact on Market Notable Agencies/Policies
US CDC guidelines on antimicrobial use and resistance Drives stewardship efforts FDA approvals, post-market surveillance
Europe EUAMR Action Plan Promotes rational antibiotic use EMA regulatory framework
Asia-Pacific Varying policies, emerging stewardship programs Rapid market expansion Local regulatory bodies, WHO guidance
Global WHO Global Action Plan (2015) Calls for optimizing antibiotic use Emphasis on innovation, resistance management

6. Key Challenges and Opportunities

Challenges

  • Rising antimicrobial resistance reducing efficacy.
  • Regulatory hurdles for new formulations.
  • Market saturation with generics.
  • Counterfeit drug proliferation, especially in emerging markets.

Opportunities

  • Development of extended-release formulations.
  • Novel combinations targeting resistant strains.
  • Expansion into topical and alternative delivery systems.
  • Strategic partnerships in emerging markets.

7. Key Takeaways

  • Clinical focus centers on overcoming resistance, improving bioavailability, and expanding indications.
  • Market growth remains steady, with a CAGR of 4.2%, driven by antimicrobial demand and innovative formulations.
  • Regulatory environments influence product approval and stewardship policies.
  • Resistance patterns necessitate ongoing development to maintain clinical utility.
  • Emerging markets present substantial growth opportunities due to unmet needs and expanding healthcare infrastructure.

8. Frequently Asked Questions

Q1: How is resistance affecting the clinical efficacy of Amoxicillin-Clavulanate?
A: Increasing β-lactamase production among bacteria, especially extended-spectrum β-lactamases (ESBLs), reduces efficacy. Ongoing clinical trials aim to optimize dosing and develop formulations to address this trend.

Q2: Are new formulations of Amoxicillin-Clavulanate being developed?
A: Yes, recent trials focus on bioavailability enhancements, extended-release formats, and combination therapies to improve outcomes and combat resistance.

Q3: What are the main indications for Amoxicillin-Clavulanate?
A: Primarily used for urinary tract infections, respiratory tract infections, skin and soft tissue infections, dental infections, and intra-abdominal infections.

Q4: How does the market compare regionally?
A: The North American market leads, with Europe and Asia-Pacific following. Asia-Pacific's growth is fueled by increased healthcare access and infrastructure expansion.

Q5: What is the outlook for Amoxicillin-Clavulanate over the next decade?
A: Market projections suggest moderate growth (~4.2% CAGR), driven by new formulations, expanding indications, and the ongoing battle against antimicrobial resistance.


References

  1. MarketWatch, "Global Antibiotic Market," 2023.
  2. ClinicalTrials.gov, "Amoxicillin-Clavulanate Studies," 2021–2023.
  3. World Health Organization, "Global Action Plan on Antimicrobial Resistance," 2015.
  4. Grand View Research, "Antibiotics Market Analysis," 2022.
  5. U.S. Food and Drug Administration, "Antibiotic Regulations," 2023.

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