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

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ClinicalTrials.gov Identifier: NCT00354965

Recruitment Status : Completed

First Posted : July 20, 2006

Last Update Posted : August 1, 2017

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Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Infections, Respiratory Tract	Drug: amoxicillin/clavulanate potassium	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	52 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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
Actual Study Start Date :	January 19, 2006
Actual Primary Completion Date :	April 2, 2007
Actual Study Completion Date :	April 2, 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Drug Information available for: Potassium bicarbonate Amoxicillin Amoxicillin sodium Clavulanate potassium

Genetic and Rare Diseases Information Center resources: Acute Graft Versus Host Disease

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: ARM 1	Drug: amoxicillin/clavulanate potassium amoxicillin/clavulanate potassium

Outcome Measures

Primary Outcome 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 Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	up to 16 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00354965

Locations

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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

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Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

Additional Information:

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