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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR AUGMENTIN XR


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505(b)(2) Clinical Trials for Augmentin Xr

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

All Clinical Trials for Augmentin Xr

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

Clinical Trial Conditions for Augmentin Xr

Condition Name

Condition Name for Augmentin Xr
Intervention Trials
Healthy 8
Sinusitis 6
Infection 4
Acute Otitis Media 4
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Condition MeSH

Condition MeSH for Augmentin Xr
Intervention Trials
Infections 9
Sinusitis 8
Infection 8
Communicable Diseases 7
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Clinical Trial Locations for Augmentin Xr

Trials by Country

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

Clinical Trial Phase

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

Sponsor Name

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

Sponsor Type for Augmentin Xr
Sponsor Trials
Other 83
Industry 30
NIH 5
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AUGMENTIN XR: Clinical Trials, Market Analysis, and Projections

Introduction

AUGMENTIN XR, a combination of amoxicillin and clavulanate potassium, is an extended-release antibiotic indicated for the treatment of community-acquired pneumonia and acute bacterial sinusitis. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials Overview

Patient Population and Efficacy

In clinical trials, AUGMENTIN XR has been evaluated in a significant number of patients. A total of 5,643 patients have been treated with AUGMENTIN XR, demonstrating its efficacy in treating infections caused by β-lactamase-producing pathogens and Streptococcus pneumoniae with reduced susceptibility to penicillin[4].

Key Studies

Several pivotal studies have been conducted to assess the clinical and bacteriological efficacy of AUGMENTIN XR. These include:

  • Community-Acquired Pneumonia (CAP): Studies 546, 556, 557, and 600 compared AUGMENTIN XR 2000/125mg twice daily with other formulations of AUGMENTIN. These studies showed that AUGMENTIN XR was effective, although non-inferiority was not demonstrated in all cases, particularly in study 546[1].
  • Acute Bacterial Sinusitis (ABS): Non-comparative studies (551 and 592) supported the bacteriological and clinical efficacy of AUGMENTIN XR in treating ABS, especially in patients with penicillin-resistant Streptococcus pneumoniae (PRSP)[1].

Adverse Reactions

Clinical trials have identified common adverse reactions associated with AUGMENTIN XR, including diarrhea (15%), vaginal mycosis (3%), nausea (2%), and loose stools (2%). A higher rate of diarrhea requiring corrective therapy was noted compared to comparators[4].

Market Analysis

Indications and Usage

AUGMENTIN XR is specifically indicated for the treatment of community-acquired pneumonia and acute bacterial sinusitis caused by susceptible bacteria. It is crucial to use this drug only when infections are proven or strongly suspected to be caused by such bacteria to prevent the development of drug-resistant bacteria[2][4].

Dosage and Administration

The recommended dose of AUGMENTIN XR is 4,000 mg/250 mg daily, administered as two tablets every 12 hours. The duration of treatment varies between 7-10 days for community-acquired pneumonia and 10 days for acute bacterial sinusitis[2][4].

Market Dynamics Post-LOE (Loss of Exclusivity)

Following the loss of exclusivity, the market dynamics for AUGMENTIN XR have been unique. Unlike other drugs, AUGMENTIN XR experienced a substantial increase in total molecule utilization post-LOE, particularly driven by third-party payer (TPP) prescriptions. This is despite the absence of authorized generic entry during the 180-day exclusivity period. The post-LOE price decline was also more pronounced and sustained for AUGMENTIN XR compared to other drugs[3].

Market Projections

Utilization Trends

The increase in utilization post-LOE suggests a strong market presence for AUGMENTIN XR. This trend is expected to continue, driven by its efficacy and the preference of healthcare providers and payers. However, the variability in utilization across different payer types, such as Medicaid and Medicare, needs to be monitored closely[3].

Price Dynamics

The price per day of therapy for AUGMENTIN XR is expected to remain relatively stable during the exclusivity window but will likely decline sharply after the expiry of exclusivity. The sustained price decline post-LOE indicates a competitive market environment, which could impact the revenue projections for the drug[3].

Competitive Landscape

AUGMENTIN XR operates in a competitive antibiotic market, but its extended-release formulation and specific indications give it a unique position. The absence of authorized generics during the exclusivity period has contributed to its market stability, but future generic entries could alter the competitive landscape[3].

Challenges and Opportunities

Resistance and Susceptibility

One of the significant challenges is the increasing resistance of bacteria to antibiotics. AUGMENTIN XR's efficacy against β-lactamase-producing pathogens is a key advantage, but continuous monitoring of bacterial susceptibility patterns is essential to maintain its effectiveness[2][4].

Regulatory Environment

Regulatory guidelines emphasize the need to use antibiotics judiciously to prevent resistance. AUGMENTIN XR's use must be aligned with these guidelines, considering local epidemiology and susceptibility patterns. This aligns with the broader strategy to maintain the effectiveness of antibacterial drugs[2][4].

Key Takeaways

  • Efficacy: AUGMENTIN XR has demonstrated strong clinical and bacteriological efficacy in treating community-acquired pneumonia and acute bacterial sinusitis.
  • Market Dynamics: Post-LOE, AUGMENTIN XR has seen increased utilization and a sustained price decline, indicating a competitive market.
  • Challenges: Bacterial resistance and regulatory compliance are critical factors to consider.
  • Projections: Continued strong market presence with potential impacts from future generic entries and price dynamics.

Frequently Asked Questions (FAQs)

What are the primary indications for AUGMENTIN XR?

AUGMENTIN XR is indicated for the treatment of community-acquired pneumonia and acute bacterial sinusitis due to confirmed or suspected β-lactamase-producing pathogens and Streptococcus pneumoniae with reduced susceptibility to penicillin[2][4].

What is the recommended dosage for AUGMENTIN XR?

The recommended dose is 4,000 mg/250 mg daily, administered as two tablets every 12 hours, for 7-10 days for community-acquired pneumonia and 10 days for acute bacterial sinusitis[2][4].

What are the common adverse reactions associated with AUGMENTIN XR?

Common adverse reactions include diarrhea, vaginal mycosis, nausea, and loose stools. Diarrhea requiring corrective therapy is also noted[4].

How has the market for AUGMENTIN XR changed post-LOE?

Post-LOE, AUGMENTIN XR has seen a substantial increase in utilization and a sustained price decline, driven primarily by TPP prescriptions[3].

What are the regulatory considerations for using AUGMENTIN XR?

AUGMENTIN XR should be used only to treat infections proven or strongly suspected to be caused by susceptible bacteria, considering culture and susceptibility information, local epidemiology, and susceptibility patterns[2][4].

Sources:

  1. TGA Product Information: AUGMENTIN XR 1000/62.5 Tablets[1].
  2. Drugs.com: AUGMENTIN XR Package Insert / Prescribing Information[2].
  3. MIT Sloan: The Regulation of Prescription Drug Competition and Market[3].
  4. FDA Label: AUGMENTIN XR Extended Release Tablets[4].

More… ↓

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