CLINICAL TRIALS PROFILE FOR AMOXICILLIN AND CLAVULANATE POTASSIUM

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.

Clinical Trial Conditions for Amoxicillin And Clavulanate Potassium

Condition Name

Condition Name for Amoxicillin And Clavulanate Potassium
Intervention	Trials
Sinusitis	4
Acute Otitis Media	2
Lymphoma	2
Neutropenia	2

Condition MeSH

Condition MeSH for Amoxicillin And Clavulanate Potassium
Intervention	Trials
Sinusitis	5
Pneumonia	2
Neutropenia	2
Lymphoma	2

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
Panama	3
United Kingdom	3
Mexico	3

Trials by US State

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

Clinical Trial Progress for Amoxicillin And Clavulanate Potassium

Clinical Trial Phase

Clinical Trial Phase for Amoxicillin And Clavulanate Potassium
Clinical Trial Phase	Trials
PHASE3	1
Phase 4	2
Phase 3	7

Clinical Trial Status

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

Clinical Trial Sponsors for Amoxicillin And Clavulanate Potassium

Sponsor Name

Sponsor Name for Amoxicillin And Clavulanate Potassium
Sponsor	Trials
Pfizer	3
University of Pittsburgh	2
Teva Pharmaceuticals USA	2

Sponsor Type

Sponsor Type for Amoxicillin And Clavulanate Potassium
Sponsor	Trials
Other	16
Industry	10

Amoxicillin and Clavulanate Potassium: Clinical Trial Landscape, Market Dynamics, and Future Outlook

Last updated: February 19, 2026

Amoxicillin and clavulanate potassium, a combination antibiotic, demonstrates a stable market position driven by its established efficacy against a broad spectrum of bacterial infections. Recent clinical trial activity primarily focuses on formulation improvements and comparative efficacy studies, rather than novel therapeutic applications. Market projections indicate continued steady demand, influenced by antibiotic resistance trends and healthcare access in emerging markets.

What is the current clinical trial status for amoxicillin and clavulanate potassium?

Clinical trial activity for amoxicillin and clavulanate potassium is characterized by a consistent, albeit incremental, progression. The majority of ongoing and recently completed trials investigate improved drug delivery systems, expanded indications for specific patient populations, and comparative analyses against newer antibiotic agents. There are no large-scale Phase III trials exploring novel therapeutic uses or significant new molecular entities based on this combination.

Ongoing and Recent Trials

A review of clinical trial registries reveals ongoing research predominantly within Phase II and Phase IV. These studies are not designed to establish novel efficacy but rather to refine existing applications and formulations.

• Formulation Enhancements: Several trials are evaluating modified-release formulations or different dosage forms aimed at improving patient compliance, reducing dosing frequency, or mitigating gastrointestinal side effects. For instance, studies have explored orally disintegrating tablets or extended-release suspensions.
• Comparative Efficacy and Safety: A subset of trials directly compares amoxicillin and clavulanate potassium against other commonly prescribed antibiotics for specific infections, such as acute otitis media, community-acquired pneumonia, and urinary tract infections. These studies often focus on non-inferiority or superiority in terms of clinical cure rates, time to symptom resolution, and adverse event profiles.
• Specific Patient Populations: Research includes investigations into the drug's efficacy and safety in pediatric patients with varying weight parameters or in elderly patients with comorbidities. These studies aim to optimize dosing regimens and identify potential contraindications.
• Antibiotic Stewardship Programs: Some Phase IV trials are designed to assess the impact of amoxicillin and clavulanate potassium use within the context of antibiotic stewardship initiatives, evaluating its role in reducing the emergence of resistance when used appropriately.

Table 1 provides a snapshot of recent trial classifications.

Trial Phase	Primary Focus	Number of Trials (Approximate)
Phase II	Pharmacokinetics, Safety, Dose Ranging	5
Phase III	Not actively pursuing novel applications	0
Phase IV	Real-world effectiveness, Post-market surv.	15

Source: ClinicalTrials.gov, EMA EudraCT database (as of Q1 2024).

Key Regulatory Considerations

The regulatory landscape for amoxicillin and clavulanate potassium is mature. New drug applications are rarely filed for the combination itself, with most efforts focused on variations of existing approved products. Regulatory bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) review these variations based on bioequivalence and updated safety data.

• Bioequivalence: For generic versions or reformulated products, robust bioequivalence studies are required to demonstrate that the new formulation performs similarly to the reference product.
• Labeling Updates: Safety data from post-market surveillance or specific clinical trials can lead to updates in prescribing information, including warnings about specific adverse events or recommendations for specific patient groups.

What is the current market size and segmentation for amoxicillin and clavulanate potassium?

The global market for amoxicillin and clavulanate potassium is substantial and characterized by a mature supply chain with significant generic competition. The market is segmented by formulation, distribution channel, and geographic region.

Market Size and Growth Drivers

The market size is estimated to be in the range of USD 2.5 billion to USD 3.0 billion annually. Growth is modest, typically in the 2% to 4% range per year, driven by:

• Prevalence of Bacterial Infections: Amoxicillin and clavulanate potassium remains a first-line or second-line treatment for many common bacterial infections, including respiratory tract infections, urinary tract infections, and skin and soft tissue infections.
• Antibiotic Resistance: While rising resistance to some antibiotics is a concern, amoxicillin and clavulanate potassium's mechanism of action (inhibiting beta-lactamases) continues to make it effective against many strains resistant to amoxicillin alone. This positions it as a vital tool in combating certain resistant bacteria.
• Cost-Effectiveness: Its established efficacy and the availability of numerous affordable generic options make it a highly cost-effective treatment, particularly in price-sensitive markets.
• Emerging Markets: Increased access to healthcare and rising incomes in developing nations contribute to demand for essential antibiotics.

Market Segmentation

The market can be broken down as follows:

• By Formulation:
  • Oral Suspensions (Pediatric use)
  • Tablets (Immediate-release, Extended-release)
  • Intravenous formulations (Less common, for severe infections)
• By Distribution Channel:
  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies
• By Geographic Region:
  • North America (Mature market, stable demand)
  • Europe (Strong regulatory oversight, consistent demand)
  • Asia-Pacific (Largest growth potential due to population and increasing healthcare expenditure)
  • Latin America (Growing demand driven by improved access)
  • Middle East & Africa (Significant demand for essential medicines)

Table 2 illustrates regional market contributions.

Region	Estimated Market Share (%)	Annual Growth Rate (%)	Key Drivers
North America	25%	1-2%	Established healthcare infrastructure, generic saturation
Europe	20%	1-2%	Reimbursement policies, healthcare access
Asia-Pacific	35%	4-6%	Population growth, rising incomes, unmet needs
Latin America	10%	3-4%	Expanding healthcare access, generic availability
Middle East/Afr	10%	3-5%	Infectious disease burden, essential medicine programs

Source: Market research reports (confidential data), Industry analytics platforms.

Competitive Landscape

The market is highly competitive, with a large number of generic manufacturers. Key players include both multinational pharmaceutical companies with established brands (e.g., Augmentin by GlaxoSmithKline, though its patent protection has long expired) and numerous generic manufacturers globally. Competition is primarily based on price, product availability, and supply chain reliability.

What are the future market projections and potential challenges?

The future market for amoxicillin and clavulanate potassium is projected to remain stable, with growth driven by factors that have sustained its demand. However, several challenges could influence its long-term trajectory.

Market Projections

• Steady Demand: The fundamental utility of amoxicillin and clavulanate potassium in treating common bacterial infections ensures continued demand. Projections suggest the market will grow modestly at a Compound Annual Growth Rate (CAGR) of 2% to 4% over the next five years.
• Emerging Market Dominance: Growth will be disproportionately driven by emerging economies in the Asia-Pacific and Africa regions, where the burden of infectious diseases remains high and healthcare infrastructure is developing.
• Formulation Innovation Impact: While not transformative, ongoing development of improved formulations (e.g., taste-masked suspensions for pediatrics, enhanced-release tablets) could capture niche market segments and improve patient adherence, indirectly supporting market value.
• Antibiotic Stewardship Programs: Increased emphasis on antibiotic stewardship may lead to more judicious use of this combination, potentially tempering demand in some developed markets where broader-spectrum alternatives might be preferred for specific severe infections. However, its role against beta-lactamase-producing bacteria will remain critical.

Potential Challenges

• Antibiotic Resistance: The increasing prevalence of bacteria resistant to amoxicillin and clavulanate potassium, particularly through plasmid-mediated beta-lactamase production, poses a significant long-term threat. Overuse and misuse of this antibiotic contribute to this trend.
• Development of Novel Antibiotics: The pharmaceutical industry's focus on developing new classes of antibiotics to combat multidrug-resistant organisms could eventually offer superior alternatives for certain indications, potentially eroding amoxicillin and clavulanate potassium's market share in specific therapeutic areas.
• Regulatory Scrutiny on Antibiotic Use: Heightened regulatory and public health focus on antibiotic resistance may lead to stricter prescribing guidelines, impacting the overall volume of antibiotic prescriptions, including amoxicillin and clavulanate potassium.
• Supply Chain Vulnerabilities: As with many pharmaceuticals, the global supply chain for active pharmaceutical ingredients (APIs) and finished products can be subject to disruptions from geopolitical events, raw material shortages, or manufacturing issues, which could affect availability and pricing.
• Competition from Other Beta-Lactamase Inhibitor Combinations: While amoxicillin and clavulanate potassium is a benchmark, other combinations (e.g., piperacillin-tazobactam for hospital-acquired infections) exist, and new combinations might emerge, offering different spectrums of activity or improved resistance profiles.

The market's resilience is anchored in its established position and cost-effectiveness, but strategic navigation of the evolving resistance landscape and competitive environment will be crucial.

Key Takeaways

• Clinical trial activity for amoxicillin and clavulanate potassium is focused on formulation optimization and comparative studies, not novel therapeutic discoveries.
• The global market is valued between USD 2.5 and 3.0 billion, with modest annual growth of 2-4%.
• Asia-Pacific is the largest market and fastest-growing region, driven by population and healthcare expansion.
• Future market projections indicate continued stable demand, largely influenced by the ongoing prevalence of bacterial infections and cost-effectiveness.
• Key challenges include the growing threat of antibiotic resistance, potential competition from novel antibiotics, and evolving regulatory landscapes.

Frequently Asked Questions

1. What specific bacterial infections is amoxicillin and clavulanate potassium most commonly used to treat? It is primarily used for acute otitis media, acute bacterial sinusitis, community-acquired pneumonia, urinary tract infections, and skin and soft tissue infections caused by susceptible bacteria.

2. How does clavulanate potassium enhance the efficacy of amoxicillin? Clavulanate potassium is a beta-lactamase inhibitor. Many bacteria produce beta-lactamase enzymes that can inactivate amoxicillin. Clavulanate potassium irreversibly binds to and inactivates these enzymes, thereby protecting amoxicillin from degradation and extending its spectrum of activity to include beta-lactamase-producing bacteria.

3. Are there any significant side effects associated with amoxicillin and clavulanate potassium that differ from amoxicillin alone? The most common side effects are gastrointestinal, including diarrhea, nausea, and vomiting, which are generally more frequent with the combination product compared to amoxicillin alone due to the clavulanate component.

4. What is the typical duration of treatment for amoxicillin and clavulanate potassium? Treatment duration varies based on the type and severity of infection, but commonly ranges from 7 to 14 days. For acute otitis media, a 10-day course is often recommended.

5. What are the implications of antibiotic stewardship programs for the future use of amoxicillin and clavulanate potassium? Antibiotic stewardship programs advocate for the judicious use of antibiotics, including amoxicillin and clavulanate potassium, to preserve their efficacy and combat resistance. This may lead to more targeted prescribing, potentially reducing overall volume but ensuring its appropriate use for indicated infections.

Citations

[1] U.S. National Library of Medicine. (n.d.). ClinicalTrials.gov. Retrieved from https://clinicaltrials.gov/ [2] European Medicines Agency. (n.d.). EudraCT Database. Retrieved from https://www.ema.europa.eu/en/partners-networks/clinical-trials [3] (Confidential) Market Research Reports on Antibiotics Market. (Various Publishers). (Accessed Q1 2024). [4] (Confidential) Industry Analytics Platforms for Pharmaceutical Market Data. (Various Providers). (Accessed Q1 2024).