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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR AUGMENTIN '200'


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505(b)(2) Clinical Trials for Augmentin '200'

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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Augmentin '200'

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Augmentin '200'

Condition Name

Condition Name for Augmentin '200'
Intervention Trials
Healthy 8
Sinusitis 6
Acute Otitis Media 4
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Condition MeSH

Condition MeSH for Augmentin '200'
Intervention Trials
Infections 9
Sinusitis 8
Infection 8
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Clinical Trial Locations for Augmentin '200'

Trials by Country

Trials by Country for Augmentin '200'
Location Trials
United States 82
France 19
Canada 7
Switzerland 4
Estonia 4
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Trials by US State

Trials by US State for Augmentin '200'
Location Trials
California 10
Pennsylvania 6
Texas 5
Ohio 5
Massachusetts 4
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Clinical Trial Progress for Augmentin '200'

Clinical Trial Phase

Clinical Trial Phase for Augmentin '200'
Clinical Trial Phase Trials
Phase 4 27
Phase 3 7
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Augmentin '200'
Clinical Trial Phase Trials
Completed 45
Not yet recruiting 11
Recruiting 6
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Clinical Trial Sponsors for Augmentin '200'

Sponsor Name

Sponsor Name for Augmentin '200'
Sponsor Trials
GlaxoSmithKline 6
Teva Pharmaceuticals USA 4
Pfizer 4
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Sponsor Type

Sponsor Type for Augmentin '200'
Sponsor Trials
Other 83
Industry 30
NIH 5
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Augmentin '200': Clinical Trials, Market Analysis, and Projections

Introduction

Augmentin, a combination of amoxicillin and clavulanic acid, is a widely used antibiotic for treating various bacterial infections, including urinary tract infections (UTIs), pneumonia, and bronchitis. Here, we will delve into recent clinical trials, market analysis, and future projections for Augmentin '200'.

Clinical Trials Update

Recent Comparative Studies

A significant recent study is the REASSURE trial, which compared oral sulopenem with oral amoxicillin/clavulanate (Augmentin) for the treatment of uncomplicated urinary tract infections (uUTIs) in women. The trial demonstrated that while both treatments were effective, oral sulopenem showed statistical superiority over Augmentin in terms of overall response and microbiologic eradication[1].

In another context, the ANODE trial investigated the use of a single prophylactic dose of intravenous amoxicillin and clavulanic acid to prevent infections after operative procedures. The trial found that women who received this prophylactic dose had significantly fewer confirmed or suspected infections compared to those who received a placebo[4].

Ongoing Research and Trials

As of October 2024, there are 39 ongoing clinical trials involving clavulanic acid, with 32 recruiting and seven active but not recruiting. These trials explore the use of clavulanic acid in various applications, including surgical site infections, dental infections, and even non-infectious conditions like cocaine use disorder and obstetric perineal tear[3].

Market Analysis

Current Market Size and Trends

The amoxicillin market, which includes Augmentin, was valued at $4.8 billion in 2022 and is expected to reach $5.3 billion by 2030, growing at a CAGR of 1.2% during the forecast period 2023-2030. This growth is driven by the increasing demand for antibiotics to treat bacterial infections[5].

Clavulanic Acid Series API Market

The clavulanic acid series API market, a crucial component of Augmentin, was estimated at US$ 385 million in 2023 and is projected to grow to US$ 777.66 million by 2034, with a CAGR of 6.6% from 2024 to 2034. This growth is fueled by rising antibiotic-resistant bacterial infections and ongoing research and development activities[3].

Key Market Players

GlaxoSmithKline plc is a major player in the amoxicillin market, producing Augmentin under various formulations such as tablets, oral suspension, and intravenous injection. Other key players include Merck KGaA, Teva Pharmaceutical Industries Ltd., Pfizer Inc., and Novartis AG[5].

Market Projections

Growth Drivers

The market for Augmentin and similar antibiotics is expected to grow due to several factors:

  • Increasing Antibiotic Resistance: The rise in antibiotic-resistant bacterial infections drives the demand for effective antibiotics like Augmentin[3].
  • Research and Development: Ongoing clinical trials and research into new applications of clavulanic acid are expected to expand the market[3].
  • Demographic Factors: Growing populations and aging demographics contribute to an increased incidence of infections that require antibiotic treatment[5].

Challenges and Opportunities

Despite the positive growth projections, the market faces challenges such as:

  • Generic Competition: The availability of generic versions of amoxicillin and clavulanic acid can impact the sales of branded products like Augmentin[5].
  • Regulatory Changes: Changes in guidelines and recommendations, such as those from the Advisory Committee on Immunization Practices (ACIP), can affect market dynamics[2].

However, opportunities exist in emerging markets and the development of new formulations, such as injectable medications, which are particularly beneficial for pediatric and geriatric populations[3].

Safety and Efficacy

Safety Profile

Clinical trials have generally shown that Augmentin is well-tolerated. For instance, the REASSURE trial noted that less than 1% of patients on both Augmentin and the comparator treatment discontinued due to adverse events, with no serious adverse events related to Augmentin[1].

Efficacy

Augmentin has been shown to be effective in various studies. The ANODE trial highlighted its efficacy in preventing post-operative infections, and it remains a standard treatment for many bacterial infections[4].

Conclusion

Augmentin '200' remains a significant player in the antibiotic market, driven by its efficacy and the ongoing need for effective treatments against bacterial infections. While it faces competition from generic alternatives and new treatments like oral sulopenem, its established market presence and ongoing research into new applications ensure its continued relevance.

Key Takeaways

  • Clinical Trials: Recent trials like the REASSURE trial and ongoing research into clavulanic acid's extended use.
  • Market Size: The amoxicillin market is projected to reach $5.3 billion by 2030.
  • Growth Drivers: Increasing antibiotic resistance and research activities.
  • Challenges: Generic competition and regulatory changes.
  • Safety and Efficacy: Generally well-tolerated with proven efficacy in various infections.

FAQs

Q1: What is the current market size of the amoxicillin market, which includes Augmentin?

The amoxicillin market, which includes Augmentin, was valued at $4.8 billion in 2022[5].

Q2: What is the projected growth rate of the clavulanic acid series API market?

The clavulanic acid series API market is projected to grow at a CAGR of 6.6% from 2024 to 2034[3].

Q3: What are the key findings of the REASSURE trial regarding Augmentin?

The REASSURE trial showed that oral sulopenem was statistically superior to Augmentin in treating uUTIs, although both treatments were effective[1].

Q4: What are the main challenges facing the Augmentin market?

The main challenges include generic competition and regulatory changes that can impact market dynamics[5].

Q5: What new applications are being explored for clavulanic acid?

Ongoing clinical trials are exploring the use of clavulanic acid in surgical site infections, dental infections, and other non-infectious conditions[3].

References

  1. Urology Times: Oral sulopenem shows superiority to amoxicillin/clavulanate for uUTIs.
  2. GSK: Q3 2024 results announcement.
  3. Towards Healthcare: Clavulanic Acid Series API Market Size, Shares and Trends.
  4. The Lancet: Prophylactic antibiotics in the prevention of infection after operative procedures.
  5. IndustryARC: Amoxicillin Market Size Report, 2023 - 2030.

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