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

NCT00354965 | Completed Phase 1

• 1 other identifier: AUG102821
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 6

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.

Conditions

Infections, Respiratory Tract

Keywords

ABS; Acute Bacterial; Sinusitis; Bacterial Sinusitis

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic data on amoxicillin/clavulanate

  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

  twice daily for 10 days in adolescent patients.

Study Arms (1)

ARM 1

EXPERIMENTAL

Drug: amoxicillin/clavulanate potassium

Interventions

amoxicillin/clavulanate potassium DRUG

amoxicillin/clavulanate potassium

ARM 1

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (6)

GSK Investigational Site

Little Rock, Arkansas, 72202, United States

Location

GSK Investigational Site

Huntington Beach, California, 92647, United States

Location

GSK Investigational Site

North Dartmouth, Massachusetts, 02747, United States

Location

GSK Investigational Site

Sylva, North Carolina, 28779, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44106, United States

Location

GSK Investigational Site

Erie, Pennsylvania, 16506, United States

Location

Related 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.

MeSH Terms

Conditions

Respiratory Tract Infections; Sinusitis

Interventions

Amoxicillin-Potassium Clavulanate Combination

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Paranasal Sinus Diseases; Nose Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2006
• First Posted: July 20, 2006
• Study Start: January 19, 2006
• Primary Completion: April 2, 2007
• Study Completion: April 2, 2007
• Last Updated: August 1, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

US (6)