CLINICAL TRIALS PROFILE FOR AUGMENTIN '875'

505(b)(2) Clinical Trials for Augmentin '875'

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Dosage	NCT02778828 ↗	Pharmacokinetic and Therapeutic Adaptation of Linezolid in the Treatment of Multi-Resistant Tuberculosis	Completed	Groupe Hospitalier Paris Saint Joseph	N/A	2015-11-04	Linezolid, primary treatment for MDR-TB combination therapy anti. Until it is the dose of 600 mg x1 / day, rather sensible for most patients is more, which was unanimous. It is true that if a dosage is consensus, it goes without saying, because of the interindividual variability, marked moreover to linezolid, a therapeutic monitoring assay of plasma levels is indispensable for most pharmacological treatments. This therapeutic drug monitoring (TDM) often gives rise, as known, to dosage changes. It turns out that at present no real STP on the basic objectives PK / PD is really made in France in the treatment of tuberculosis (TB) and the bibliography remains rather poor recommendations, and yet all the elements are there: indeed linezolid is an antibiotic whose activity is purely "time-dependent". So one should fulfill 2 PK / PD objectives whose precise boundaries are sometimes still to be determined: -% T> MIC, or percentage of time spent with plasma concentrations above the minimum inhibitory concentration of linezolid (LNZ) for Mycobacterium tuberculosis. In practice, the residual concentration before the next shot must be> MIC (0.125 to 1 mg / l) - A fortiori it must also take into account the concentration preventing the appearance of resistant mutants, amounting to 1.2 mg / l - AUC / MIC> 80, or ratio of the area under the curve (AUC, Area under curve) of plasma concentration versus time and CMI LNZ Until then, and without real bibliographic support, and for the sake of kindness to patients coupled with an economic advantage, the STP consisted of 2 samples, a peak 1:30 after taking (Cmax) and a residual before taking (C min) , after all, to 600mg x1 / 24 correlates well with the AUC (55% peak and 75% for the residual). Following an observation that 25 to 30% of patients had a C min
OTC	NCT06076304 ↗	Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis	Active, not recruiting	Medstar Health Research Institute	Phase 4	2023-11-21	Sinus infections are sometimes treated with antibiotics or nasal sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.
OTC	NCT06076304 ↗	Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis	Active, not recruiting	Patient-Centered Outcomes Research Institute	Phase 4	2023-11-21	Sinus infections are sometimes treated with antibiotics or nasal sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.
OTC	NCT06076304 ↗	Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis	Active, not recruiting	Penn State College of Medicine	Phase 4	2023-11-21	Sinus infections are sometimes treated with antibiotics or nasal sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.
OTC	NCT06076304 ↗	Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis	Active, not recruiting	University of California, Los Angeles	Phase 4	2023-11-21	Sinus infections are sometimes treated with antibiotics or nasal sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.

All Clinical Trials for Augmentin '875'

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.
NCT00174694 ↗	CHOOSE : Telithromycin, Acute Bacterial Sinusitis	Completed	Sanofi	Phase 4	2004-11-01	Primary objective: - To demonstrate that the clinical efficacy of telithromycin (800 mg od for 5 days) is non-inferior to amoxicillin-clavulanic acid (875/125 mg bid for 10 days) at the test-of-cure (TOC) visit (Day 17-21) in subjects with acute bacterial sinusitis (ABS). Secondary objective(s): - To assess the time to resolution of signs and symptoms between the baseline (Day 1) and TOC (Day 17-21) visits, - To assess the rate of clinical relapse at the follow-up visit (Day 41-49), - To assess health economic outcome until follow-up visit (Day 41-49), - To assess quality of life up to the follow-up visit (Day 41-49), - To compare the safety of telithromycin and amoxicillin-clavulanic acid, - To compare the bacteriologic outcome of both treatments as observed at TOC (Day 17-21) and at follow-up visit (Day 41-49),in subjects with ABS.
NCT00185939 ↗	The Use of Prophylactic Antibiotics In the Management of Dog Bites	Completed	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Phase 2/Phase 3	2003-08-01	This double blinded RCT will help to ascertain the usefulness of prophylactic antibiotics in the management of uncomplicated dog bites, utilizing currently best available antibiotics (Augmentin) and an important clinical outcome of infection. By enrolling 100-150 patients in this pilot trial as part of a k-award the investigators plan to utilize the point estimates of infection, side effects and other important outcomes and incorporate these into a cost most to determine the most cost effective management of these wounds and to determine if further study is warranted based on the findings.
NCT00185939 ↗	The Use of Prophylactic Antibiotics In the Management of Dog Bites	Completed	Stanford University	Phase 2/Phase 3	2003-08-01	This double blinded RCT will help to ascertain the usefulness of prophylactic antibiotics in the management of uncomplicated dog bites, utilizing currently best available antibiotics (Augmentin) and an important clinical outcome of infection. By enrolling 100-150 patients in this pilot trial as part of a k-award the investigators plan to utilize the point estimates of infection, side effects and other important outcomes and incorporate these into a cost most to determine the most cost effective management of these wounds and to determine if further study is warranted based on the findings.
NCT00343135 ↗	AUGMENTIN 1gm In Skin And Soft Tissue Infection	Completed	GlaxoSmithKline	Phase 4	2004-12-01	Study to evaluate the effects of AUGMENTIN 1gm in the treatment of Skin and Soft tissue infections

Clinical Trial Conditions for Augmentin '875'

Condition Name

Condition Name for Augmentin '875'
Intervention	Trials
Healthy	8
Sinusitis	6
Acute Otitis Media	4
Infection	4

Condition MeSH

Condition MeSH for Augmentin '875'
Intervention	Trials
Infections	9
Sinusitis	8
Infection	8
Communicable Diseases	7

Clinical Trial Locations for Augmentin '875'

Trials by Country

Trials by Country for Augmentin '875'
Location	Trials
United States	82
France	19
Canada	7
Switzerland	4
Estonia	4

Trials by US State

Trials by US State for Augmentin '875'
Location	Trials
California	10
Pennsylvania	6
Texas	5
Ohio	5
Massachusetts	4

Clinical Trial Progress for Augmentin '875'

Clinical Trial Phase

Clinical Trial Phase for Augmentin '875'
Clinical Trial Phase	Trials
PHASE3	1
Phase 4	27
Phase 3	7

Clinical Trial Status

Clinical Trial Status for Augmentin '875'
Clinical Trial Phase	Trials
Completed	46
Not yet recruiting	11
Unknown status	6

Clinical Trial Sponsors for Augmentin '875'

Sponsor Name

Sponsor Name for Augmentin '875'
Sponsor	Trials
GlaxoSmithKline	6
Teva Pharmaceuticals USA	4
Pfizer	4

Sponsor Type

Sponsor Type for Augmentin '875'
Sponsor	Trials
Other	84
Industry	30
NIH	5

Clinical Trials Update, Market Analysis, and Projection for Augmentin 875

Last updated: November 8, 2025

Introduction

Augmentin 875, a combination of amoxicillin and clavulanic acid, remains a cornerstone in the treatment of various bacterial infections. Its efficacy against resistant pathogens, favorable safety profile, and broad-spectrum activity sustain its relevance in both clinical and commercial landscapes. This report provides a comprehensive update on clinical trial developments, analyzes current market dynamics, and presents future market projections for Augmentin 875.

Clinical Trials Update

Ongoing and Recent Clinical Investigations

Recent years have seen Augmentin 875 involved in several pivotal studies aimed at expanding its indications and assessing resistance patterns. Notably:

• Resistance Surveillance Studies: Multiple observational studies evaluate the efficacy of Augmentin 875 against Escherichia coli and Staphylococcus aureus strains exhibiting beta-lactamase production, which are common culprits of antibiotic resistance. These investigations underscore its continued relevance amidst rising drug-resistant pathogens.

• Population Pharmacokinetics: Several pharmacokinetic/pharmacodynamic (PK/PD) studies validate dosing regimens tailored for specific populations, including pediatric, geriatric, and immunocompromised groups, ensuring optimized therapeutic outcomes.

• Clinical Efficacy Trials: Randomized controlled trials (RCTs) compare Augmentin 875 to newer beta-lactam/beta-lactamase inhibitor combinations. For example, recent Phase IV studies assess its effectiveness in sinusitis, lower respiratory tract infections, and urinary tract infections—common indications for the drug.

Regulatory Status and Label Updates

While Augmentin 875 is FDA-approved for various bacterial infections, regulatory agencies have emphasized the importance of antimicrobial stewardship. Recent updates include:

• Label Revision: The FDA updated prescribing information to emphasize appropriate use, highlighting scenarios with resistant organisms and advocating for susceptibility testing prior to use.

• Adverse Event Monitoring: Post-marketing surveillance continues to monitor rare side effects, such as hypersensitivity reactions and gastrointestinal disturbances, ensuring ongoing safety assessment.

Emerging Research Trends

Emerging research explores:

• Combination Therapy: Augmentin 875 paired with newer agents to combat multidrug-resistant bacteria.

• Biomarker Development: Studies investigating biomarkers predictive of therapeutic response, aiming to tailor therapy more precisely.

• Alternative Formulations: Development of fixed-dose combinations and extended-release formulations to improve adherence.

Market Analysis

Current Market Size

Augmentin remains among the top-selling antibiotics globally, with a valuation of approximately USD 2.5 billion in 2022, according to global pharmaceutical market data [1]. The drug's consistent performance across developed and developing nations sustains its market dominance.

Key Market Drivers

• High Incidence of Bacterial Infections: Persistent prevalence of respiratory, urinary, and skin infections drives demand.

• Resistance Trends: Rising beta-lactamase-mediated resistance maintains the relevance of Augmentin’s clavulanic acid component.

• Prescribing Preferences: Clinicians favor Augmentin for its broad-spectrum activity, especially in outpatient settings.

• Generic Availability: Widespread manufacturing and cost competitiveness bolster accessibility.

Market Challenges

• Antimicrobial Stewardship Initiatives: Growing emphasis on prudent antibiotic use aims to curb overprescription, potentially restricting sales.

• Emerging Alternatives: Newer antibiotics with narrower spectra and improved safety profiles threaten market share.

• Revenue Impact of Resistance: While resistance enhances demand, it also risks compromising efficacy, necessitating ongoing development.

Regional Market Dynamics

• North America: Mature market with high prescribing rates; however, stewardship programs temper growth.

• Europe: Similar trends with rigorous regulatory oversight; growth driven by infection management needs.

• Asia-Pacific: Rapidly expanding markets due to increasing infection burden and healthcare infrastructure improvements, presenting significant growth opportunities.

• Latin America & Africa: Emerging markets with expanding access, though limited by pricing and supply chain issues.

Future Market Projections

Growth Forecast

The global Augmentin market is projected to expand at a compound annual growth rate (CAGR) of approximately 4.2% from 2023 to 2028, reaching an estimated USD 3.2 billion by 2028 [2]. The growth is driven by:

• Epidemiological Trends: Continued high infection rates, especially in underserved regions.

• Resistance Patterns: Sustained reliance on beta-lactamase inhibitors to contend with resistant bacteria.

• Developments in Formulations: Introduction of patient-friendly formulations to improve adherence and treatment outcomes.

key Opportunities

• Expanding Indications: Investigations into skin and soft tissue infections, intra-abdominal infections, and resistant pathogen management.

• Strategic Partnerships: Collaborations with biotech firms to develop extended-spectrum formulations.

• Market Penetration in Emerging Economies: Focused expansion leveraging local manufacturing and affordability.

Challenges to Overcome

• Antimicrobial Stewardship Impact: Ensuring that increased awareness does not lead to excessive restrictions.

• Resistance Development: Monitoring and mitigating the potential for augmented resistance to Augmentin itself.

• Pricing Pressures: Competitive dynamics and regulatory policies may limit profit margins.

Key Takeaways

• Clinical validation continues for Augmentin 875, with ongoing studies focusing on resistance management and optimized dosing across populations.

• Market size remains substantial, driven by high infection prevalence, but faces headwinds from antimicrobial stewardship and the emergence of novel antibiotics.

• Emerging regions such as Asia-Pacific present promising growth opportunities, especially with tailored strategies that address local healthcare needs.

• Future growth hinges on pharmaceutical innovation, expanded indications, and strategic collaborations to counter resistance patterns.

• Regulatory landscape demands adherence to stewards’ guidelines, emphasizing responsible use to sustain Augmentin's efficacy.

FAQs

1. What are the main indications for Augmentin 875?
Augmentin 875 is primarily prescribed for bacterial respiratory tract infections, urinary tract infections, skin infections, and sinusitis, especially when beta-lactamase-producing bacteria are suspected.

2. How does resistance impact Augmentin’s clinical efficacy?
While Augmentin’s combination strategy effectively overcomes many beta-lactamase-producing strains, increasing resistance—particularly from organisms producing extended-spectrum beta-lactamases (ESBLs)—may reduce its efficacy, necessitating susceptibility testing and alternative treatments.

3. Are there emerging formulations of Augmentin to improve patient adherence?
Yes, pharmaceutical companies are developing extended-release and fixed-dose formulations to enhance compliance, reduce dosing frequency, and optimize therapeutic outcomes.

4. How is the market for Augmentin expected to evolve in developing countries?
Growing healthcare access, increasing bacterial infection rates, and cost-effective manufacturing support market expansion. However, local regulatory policies and stewardship programs may influence growth trajectories.

5. What role do regulatory agencies play in the future of Augmentin?
Regulators emphasize appropriate use, monitor safety, and approve new formulations or indications. Their policies aim to mitigate resistance development and ensure sustainable utilization.

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References

[1] Global Pharmaceutical Market Data, 2022. International Market Insights.
[2] Future Market Insights. "Antibiotics Market Outlook and Trends," 2023.