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Completed

NCT Number: NCT00354965

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

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.

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Key information

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, Little Rock, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

amoxicillin/clavulanate potassium

Drug

amoxicillin/clavulanate potassium

Primary outcomes

  1. 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 outcomes

  1. Safety, tolerability, and clinical response of oral amoxicillin/clavulanate

    Time frame: twice daily for 10 days in adolescent patients.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jul 20, 2006
Registry last updated
Aug 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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