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

Infections, Respiratory Tract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00354965
• Other study ID #: AUG102821
• Status: Completed
• Phase: Phase 1
• First received: July 18, 2006
• Last updated: July 31, 2017
• Start date: January 19, 2006
• Est. completion date: April 2, 2007

Study information

• Verified date: July 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 2, 2007
• Est. primary completion date: April 2, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infections, Respiratory Tract
• Respiratory Tract Infections

Intervention

Drug:
• amoxicillin/clavulanate potassium
amoxicillin/clavulanate potassium

Locations

Country	Name	City	State
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Erie	Pennsylvania
United States	GSK Investigational Site	Huntington Beach	California
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	North Dartmouth	Massachusetts
United States	GSK Investigational Site	Sylva	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic data on amoxicillin/clavulanate		Time above MIC (T>MIC)for amoxicillin when amoxicillin/clavulanate is given orally twice daily to adolescents.
Secondary	Safety, tolerability, and clinical response of oral amoxicillin/clavulanate		twice daily for 10 days in adolescent patients.

External 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.
•   Results for study AUG102821 can be found on the GSK Clinical Study Register.