Official Title: “An Open-Label Study to Determine the Pharmacokinetic Profiles of Amoxicillin and Clavulanate in Adolescent Patients Weighing at Least 40 kg and no More Than 16 Years of Age Receiving Augmentin XR (Amoxicillin 2000 mg/Clavulanate 125 mg) Orally Twice Daily for 10 Days.”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study

Intervention(s) in this Clinical Trial

• Drug: amoxicillin/clavulanate potassium

Primary Measures

• Pharmacokinetic data on amoxicillin/clavulanate
  • Time Frame: Time above MIC (T>MIC)for amoxicillin when amoxicillin/clavulanate is given orally twice daily to adolescents.
    

Secondary Measures

• Safety, tolerability, and clinical response of oral amoxicillin/clavulanate
  • Time Frame: twice daily for 10 days in adolescent patients.
    

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 16 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00354965

Study ID Number: AUG102821

ClinicalTrials.gov Identifier: NCT00354965

Health Authority: United States: Food and Drug Administration