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

A Study to Determine PK Profiles of AUGMENTIN XR in Adolescents Weight at Least 40 kg Receiving Augmentin XR BID 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 Overview

• Status: Completed
• Conditions: Infections, Respiratory Tract
• Intervention / Treatment: Drug: amoxicillin/clavulanate potassium

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • GSK Investigational Site
  • California
    • Huntington Beach, California, United States, 92647
      • GSK Investigational Site
  • Massachusetts
    • North Dartmouth, Massachusetts, United States, 02747
      • GSK Investigational Site
  • North Carolina
    • Sylva, North Carolina, United States, 28779
      • GSK Investigational Site
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • GSK Investigational Site
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16506
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARM 1	Drug: amoxicillin/clavulanate potassium; amoxicillin/clavulanate potassium

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2006
• Primary Completion (Actual): April 2, 2007
• Study Completion (Actual): April 2, 2007

Study Registration Dates

• First Submitted: July 18, 2006
• First Submitted That Met QC Criteria: July 18, 2006
• First Posted (Estimate): July 20, 2006

Study Record Updates

• Last Update Posted (Actual): August 1, 2017
• Last Update Submitted That Met QC Criteria: July 31, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Sinusitis; Bacterial Sinusitis; ABS; Acute Bacterial
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiratory Tract Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Amoxicillin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination
• Other Study ID Numbers: AUG102821

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Dataset Specification
   Information identifier: AUG102821
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Individual Participant Data Set
   Information identifier: AUG102821
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Informed Consent Form
   Information identifier: AUG102821
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Study Protocol
   Information identifier: AUG102821
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Clinical Study Report
   Information identifier: AUG102821
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Annotated Case Report Form
   Information identifier: AUG102821
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register