Pharmacokinetic Profiles Of Amoxicillin 2000 mg And Clavulanate 125 mg In Adolescent Patients

Study Overview
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Brief Summary
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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.

Official Title
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A Study to Determine PK Profiles of AUGMENTIN XR in Adolescents Weight at Least 40 kg Receiving Augmentin XR BID for 10 Days

Conditions
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Infections, Respiratory Tract

Intervention / Treatment
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* Drug: amoxicillin/clavulanate potassium


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patient weighs at least 40 kg. Younger than 16 years old (no older than their 16th birthday). Suspected acute bacterial sinusitis. Able to swallow amoxicillin/clavulanate tablets. Exclusion criteria: Personal or family history of adverse reactions or hypersensitivity or allergy to any penicillin or cephalosporin antibiotics. History of reaction to multiple allergens (if considered clinically relevant by the principal investigator). Patient is participating in another clinical trial or has received or anticipates receiving an investigational drug, vaccine, or medical device prior to the first dose of study medication or during the conduct of the study. History or presence of gastrointestinal, hepatic or renal disease or other conditions known to or that may interfere with the absorption, distribution, metabolism or excretion of study medication. Treatment with probenecid or allopurinol within 7 days of study entry. Female patients with a positive urine hCG (human chorionic gonadotropin) test at screening, or who are lactating (breast feeding) or are unwilling to be abstinent until completion of the follow-up visit. History of diarrhea due to Clostridium difficile following treatment with antibiotics. History of hypersensitivity or allergy to heparin or related preparations (if the clinical research unit uses heparin to maintain intravenous cannula patency). Patient is diagnosed with mononucleosis. Estimated Glomerular Filtration Rate (GFR) <40 ml/min.

Ages Eligible for Study
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Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARM 1<br> | Drug: amoxicillin/clavulanate potassium<br>* amoxicillin/clavulanate potassium<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic data on amoxicillin/clavulanate |  | Time above MIC (T>MIC)for amoxicillin when amoxicillin/clavulanate is given orally twice daily to adolescents. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, tolerability, and clinical response of oral amoxicillin/clavulanate |  | twice daily for 10 days in adolescent patients. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ABS, Acute Bacterial, Sinusitis, Bacterial Sinusitis