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Last Updated: February 8, 2025

CLINICAL TRIALS PROFILE FOR AUGMENTIN '250'


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505(b)(2) Clinical Trials for Augmentin '250'

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 '250'

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 '250'

Condition Name

Condition Name for Augmentin '250'
Intervention Trials
Healthy 8
Sinusitis 6
Infection 4
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Condition MeSH

Condition MeSH for Augmentin '250'
Intervention Trials
Infections 9
Sinusitis 8
Infection 8
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Clinical Trial Locations for Augmentin '250'

Trials by Country

Trials by Country for Augmentin '250'
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 '250'
Location Trials
California 10
Pennsylvania 6
Texas 5
Ohio 5
Massachusetts 4
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Clinical Trial Progress for Augmentin '250'

Clinical Trial Phase

Clinical Trial Phase for Augmentin '250'
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 '250'
Clinical Trial Phase Trials
Completed 45
Not yet recruiting 11
Recruiting 6
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Clinical Trial Sponsors for Augmentin '250'

Sponsor Name

Sponsor Name for Augmentin '250'
Sponsor Trials
GlaxoSmithKline 6
Teva Pharmaceuticals USA 4
Pfizer 4
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Sponsor Type

Sponsor Type for Augmentin '250'
Sponsor Trials
Other 83
Industry 30
NIH 5
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Augmentin 250: Clinical Trials, Market Analysis, and Projections

Introduction to Augmentin 250

Augmentin, a combination of amoxicillin and clavulanic acid, is a widely used antibiotic for treating a variety of bacterial infections. The 250 mg formulation, specifically Augmentin 250 mg/125 mg, is one of the common dosages prescribed for both adults and children.

Clinical Trials and Efficacy

Overview of Clinical Trials

Clinical trials have consistently shown the efficacy of Augmentin in treating various bacterial infections. For instance, studies have demonstrated high cure rates for infections such as otitis media caused by Haemophilus influenzae, Diplococcus pneumoniae, and Streptococcus pyogenes[1].

Specific Infections Treated

  • Respiratory Infections: Augmentin has shown high response rates in adults with bronchitis and pneumonia.
  • Urinary Tract Infections: The drug is effective against urinary tract infections caused by Escherichia coli, Proteus mirabilis, and enterococci, with a dosage of 250 mg given three times a day.
  • Skin and Soft Tissue Infections: Augmentin rapidly clears infections such as streptococcal cellulitis and impetigo.
  • Gonococcal Infections: A single 3.0-g dose of Augmentin has been shown to achieve cure rates of over 96% for uncomplicated gonococcal urethritis and cervical gonorrhea[1].

Pharmacokinetics and Dosage

Pharmacokinetic studies indicate that amoxicillin, the active component of Augmentin, has an oral bioavailability of approximately 87% and is best described by a 1-compartment model with first-order absorption[3].

For Augmentin 250 mg/125 mg, the recommended dosage is one tablet taken three times a day for adults and children weighing 40 kg or more. For children under 40 kg, the oral suspension formulation is recommended, with dosages ranging from 9 mg/4.5 mg/kg/day to 18 mg/9 mg/kg/day given in three divided doses[4].

Market Analysis

Current Market Performance

Augmentin, including the 250 mg formulation, remains a significant player in the antibiotic market. The drug's performance is part of the broader success of combination antibiotics.

  • Sales Trends: While specific sales figures for Augmentin 250 mg are not isolated in recent reports, the overall performance of antibiotics and combination therapies like Augmentin continues to be strong. For example, GSK's Specialty Medicines, which include various antibiotics, have driven sales growth in recent quarters[2].

Competitive Landscape

The antibiotic market is highly competitive, with numerous generic and branded options available. However, Augmentin's combination of amoxicillin and clavulanic acid provides a unique advantage by inhibiting beta-lactamase enzymes, thereby extending the spectrum of activity against bacteria that produce these enzymes.

  • Generic Competition: Despite the presence of generics, branded versions like Augmentin maintain market share due to their established efficacy and patient trust.
  • New Indications and Formulations: Continuous updates in dosing recommendations and new formulations, such as oral suspensions, help in maintaining market relevance[4][5].

Projections and Future Outlook

Market Growth

The demand for effective antibiotics is expected to remain high due to the ongoing need to treat bacterial infections. Here are some key projections:

  • Increasing Resistance: The rise in antibiotic resistance is likely to drive the development and use of combination therapies like Augmentin, which offer broader coverage against resistant strains.
  • Expanding Indications: New clinical trials and approvals for additional indications could further boost the market for Augmentin 250 mg.

Regulatory and Safety Considerations

Regulatory bodies continue to monitor the safety and efficacy of antibiotics, including Augmentin. Any changes in guidelines or safety profiles could impact market projections.

  • Safety Profile: Augmentin has a generally favorable safety profile, with common side effects including diarrhea, nausea, and vomiting. Rare but serious side effects such as anaphylaxis and Stevens-Johnson syndrome necessitate careful monitoring[4].

Technological Advancements

Advancements in pharmacokinetics and pharmacodynamics, as well as improvements in drug delivery systems, could enhance the efficacy and patient compliance of Augmentin 250 mg.

  • Personalized Medicine: Future studies on pharmacokinetic models could lead to more personalized dosing regimens, potentially improving treatment outcomes and reducing side effects[3].

Key Takeaways

  • Clinical Efficacy: Augmentin 250 mg has been proven effective in treating a wide range of bacterial infections.
  • Market Performance: The drug remains a significant player in the antibiotic market, driven by its unique combination and established efficacy.
  • Future Outlook: The market for Augmentin 250 mg is expected to grow, driven by increasing antibiotic resistance and potential new indications.
  • Regulatory and Safety: Continuous monitoring by regulatory bodies and a focus on safety profiles are crucial for maintaining market position.

FAQs

What is the recommended dosage of Augmentin 250 mg for adults?

For adults, the recommended dosage is one 250 mg/125 mg tablet taken three times a day[4].

What infections is Augmentin 250 mg effective against?

Augmentin 250 mg is effective against a variety of infections including otitis media, bronchitis, pneumonia, urinary tract infections, and skin and soft tissue infections[1].

Can Augmentin 250 mg be used in children?

Yes, Augmentin 250 mg can be used in children weighing 40 kg or more. For children under 40 kg, the oral suspension formulation is recommended[4].

What are the common side effects of Augmentin 250 mg?

Common side effects include diarrhea, nausea, and vomiting. Rare but serious side effects such as anaphylaxis and Stevens-Johnson syndrome can also occur[4].

How does the combination of amoxicillin and clavulanic acid in Augmentin work?

The combination extends the spectrum of activity of amoxicillin by inhibiting beta-lactamase enzymes produced by bacteria, thereby making the antibiotic effective against a broader range of bacteria[5].

Sources

  1. Experience with Amoxicillin: An Overall Summary of Clinical Trials in ... - Oxford Academic
  2. Q3 2024 Results Announcement - GSK
  3. Oral and Intravenous Amoxicillin Dosing Recommendations in ... - Oxford Academic
  4. Augmentin-article-30-annex-iii_en.pdf - European Medicines Agency
  5. Augmentin Oral Suspension: Package Insert / Prescribing Info - Drugs.com

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