CLINICAL TRIALS PROFILE FOR AUGMENTIN '500'

505(b)(2) Clinical Trials for Augmentin '500'

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 <1.2 mg / L, and even frequently <0.2 mg / L to 600 mg x 1, with some low peaks and leaving presage an AUC may be insufficient well. This study is therefore more imperative to be a pharmacological streamlining and ensuring adequate therapeutic monitoring involves both maximum and minimum toxicity efficiency. And in the light of what has already been practiced for other molecules such as mycophenolate for example which is carried AUC or miniAUC for example. It would therefore be in the achievement of AUC in all patients treated with LNZ for TB MDR / XDR for over a week. Achieving this requires AUC obtaining 7 blood samples given day instead of two samples taken at present. Indeed one must have in mind that the peak of rational / residual has become blurred in this context, and that one of the two goals PK / PD is now filled (Cmin> MIC / CMP) but it should not be that not at the expense of the second (AUC). The benefits, direct and indirect are multiple and obtaining them is ensured through this protocol. The study by analyzing individual data will confirm the accuracy of the dose fractionation 300mgx2 / day and at a time to highlight a potential new dosage adjustment that would need to achieve for further study, so a substantial gain in terms of efficacy and toxicity via a suitable therapeutic monitoring. Secondly, determine which collection points, in these patients, these doses will be most interesting to take later in the routine of STP in order to collect less points (eg miniAUC MPA) retaining same statistical power to estimate kinetic parameters, mainly the AUC (eg aminoglycoside also). Finally in a third phase construction on the basis of these individual kinetics of a population pharmacokinetic model with highlighting of population parameters and especially co-related variables explaining the high pharmacokinetic variability and allowing for following patients to determine the individually tailored dose immediately before the first shot and the first assays.
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.
OTC	NCT06076304 ↗	Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis	Active, not recruiting	University of Washington	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 '500'

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
NCT00354965 ↗	Pharmacokinetic Profiles Of Amoxicillin 2000 mg And Clavulanate 125 mg In Adolescent Patients	Completed	GlaxoSmithKline	Phase 1	2006-01-19	Clinical research study to test amoxicillin and clavulanate tablet formulation for use in Acute Bacterial Sinusitis (ABS) in adolescent patients weighing at least 40 kilogram (kg) and no more than 16 years old. ABS is an acute bacterial infection of the sinus. The purpose of this study is to find out how children tolerate Augmentin XR and what happens to Augmentin XR in the body after it has been swallowed by children.

Clinical Trial Conditions for Augmentin '500'

Condition Name

Condition Name for Augmentin '500'
Intervention	Trials
Healthy	8
Sinusitis	6
Infection	4
Acute Otitis Media	4

Condition MeSH

Condition MeSH for Augmentin '500'
Intervention	Trials
Infections	9
Infection	8
Sinusitis	8
Communicable Diseases	7

Clinical Trial Locations for Augmentin '500'

Trials by Country

Trials by Country for Augmentin '500'
Location	Trials
United States	82
France	19
Canada	7
Switzerland	4
Estonia	4

Trials by US State

Trials by US State for Augmentin '500'
Location	Trials
California	10
Pennsylvania	6
Texas	5
Ohio	5
Massachusetts	4

Clinical Trial Progress for Augmentin '500'

Clinical Trial Phase

Clinical Trial Phase for Augmentin '500'
Clinical Trial Phase	Trials
Phase 4	27
Phase 3	7
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Augmentin '500'
Clinical Trial Phase	Trials
Completed	45
Not yet recruiting	11
Unknown status	6

Clinical Trial Sponsors for Augmentin '500'

Sponsor Name

Sponsor Name for Augmentin '500'
Sponsor	Trials
GlaxoSmithKline	6
Teva Pharmaceuticals USA	4
Pfizer	4

Sponsor Type

Sponsor Type for Augmentin '500'
Sponsor	Trials
Other	83
Industry	30
NIH	5

Augmentin '500': Clinical Trials Update, Market Analysis, and Projections

Last updated: January 1, 2025

Introduction to Augmentin '500'

Augmentin, a combination antibiotic consisting of amoxicillin and clavulanate potassium, has been a staple in the treatment of various bacterial infections, including urinary tract infections (UTIs), for decades. This article will delve into the current clinical trials landscape, market analysis, and future projections for Augmentin '500', particularly in the context of emerging competitors and changing market dynamics.

Clinical Trials Update: The Rise of Competitors

Iterum Therapeutics' Oral Sulopenem

A significant development in the antibiotic market is the emergence of oral sulopenem, a next-generation oral penem antibiotic developed by Iterum Therapeutics. In the recent REASSURE trial, oral sulopenem demonstrated statistically significant superiority over Augmentin in treating uncomplicated urinary tract infections (uUTIs)[1].

• Efficacy: Oral sulopenem showed an overall success rate of 61.7% compared to 55.0% for Augmentin, meeting the primary endpoint of non-inferiority and exceeding it to demonstrate superiority.
• Safety: Both treatments were well-tolerated, with oral sulopenem having no serious adverse events (SAEs) reported, whereas Augmentin had five SAEs, none of which were drug-related.
• Market Impact: This trial's positive results position oral sulopenem as a potential first oral penem to be approved in the U.S., which could challenge Augmentin's market share in the treatment of uUTIs.

Market Analysis of Augmentin '500'

Current Market Position

Augmentin remains a widely used antibiotic due to its broad-spectrum activity and effectiveness against a variety of bacterial infections. However, its market position is facing challenges from several fronts:

• Antimicrobial Resistance: The increasing prevalence of antimicrobial resistance (AMR) reduces the efficacy of Augmentin and other antibiotics, necessitating the development of new treatments[5].
• Generic Competition: The availability of generic versions of amoxicillin and clavulanate potassium has increased market competition, leading to lower prices and a steady supply of medications[5].

Demand and Usage

The demand for Augmentin is driven by its use in treating various infections, including UTIs, lower respiratory tract infections, and skin infections. However, the rising incidence of AMR and the need for new antibiotics are shifting market dynamics.

• UTIs: Augmentin is commonly used to treat UTIs, but the emergence of drugs like oral sulopenem could alter this landscape[1].
• Other Infections: The drug is also used for other infections, but the growing resistance to current antibiotics is a significant concern[2].

Market Projections for Augmentin '500'

Global Penicillin Market Trends

The global penicillin market, which includes Augmentin, is projected to grow but faces challenges due to AMR:

• Market Size: The global penicillin drug market was valued at $8.4 billion in 2022 and is expected to reach $12.1 billion by 2032, growing at a CAGR of 3.7%[5].
• Regional Growth: The Asia-Pacific region is expected to grow at the fastest rate due to the increasing burden of infectious diseases and the demand for penicillin antibiotics[5].

Impact of Emerging Competitors

The approval and market entry of new antibiotics like oral sulopenem could impact Augmentin's market share:

• Competition from Oral Sulopenem: If approved, oral sulopenem could capture a significant portion of the uUTI treatment market, potentially reducing Augmentin's sales in this segment[1].
• Market Adaptation: Pharmaceutical companies may need to adapt their strategies to include new antibiotics or combination therapies to maintain market relevance.

Safety and Adverse Reactions of Augmentin '500'

Augmentin, while generally well-tolerated, has several potential adverse reactions that healthcare providers must be aware of:

• Severe Cutaneous Adverse Reactions (SCAR): Patients should be monitored closely for severe skin reactions, and the drug should be discontinued if a rash progresses[4].
• Hepatic Dysfunction: Augmentin can cause hepatic dysfunction and cholestatic jaundice, necessitating liver function tests in patients with hepatic impairment[4].
• Clostridioides difficile-associated Diarrhea (CDAD): Patients should be evaluated for CDAD if diarrhea occurs during or after treatment with Augmentin[4].

Key Takeaways

• Clinical Trials: Oral sulopenem has shown superiority over Augmentin in treating uUTIs, potentially altering the market landscape.
• Market Analysis: The global penicillin market is growing, but AMR and generic competition pose significant challenges.
• Market Projections: The market is expected to grow, but emerging competitors like oral sulopenem could impact Augmentin's market share.
• Safety: Healthcare providers must be aware of the potential adverse reactions associated with Augmentin.

FAQs

What is the current status of Augmentin in the treatment of urinary tract infections?

Augmentin remains a commonly used antibiotic for treating UTIs, but it faces competition from new antibiotics like oral sulopenem, which has shown superior efficacy in recent clinical trials.

How does antimicrobial resistance affect the market for Augmentin?

Antimicrobial resistance reduces the efficacy of Augmentin and other antibiotics, leading to a need for new treatments and potentially impacting sales.

What are the potential adverse reactions associated with Augmentin?

Augmentin can cause severe cutaneous adverse reactions, hepatic dysfunction, Clostridioides difficile-associated diarrhea, and other adverse effects that require careful monitoring.

How is the global penicillin market projected to grow?

The global penicillin drug market is expected to reach $12.1 billion by 2032, growing at a CAGR of 3.7%, driven by the increasing burden of infectious diseases and demand for antibiotics.

What impact could the approval of oral sulopenem have on Augmentin's market share?

The approval of oral sulopenem could significantly reduce Augmentin's market share in the treatment of uUTIs due to its demonstrated superiority in clinical trials.

Sources

1. Iterum Therapeutics Announces Positive Topline Results from its REASSURE Trial. Iterum Therapeutics, January 30, 2024.
2. Amoxicillin Production Cost Analysis Report 2025 Edition. Syndicated Analytics.
3. Antimicrobial Drugs Market Returns Analysis. ASPE, December 16, 2022.
4. AUGMENTIN (amoxicillin and clavulanate potassium) tablets. FDA.
5. Penicillin Drug Market Size, Share & Growth Report, 2032. Allied Market Research.