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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 1

Conditions

Infections, Respiratory Tract

Treatments

Drug: amoxicillin/clavulanate potassium

Study type

Interventional

Funder types

Industry

Identifiers

NCT00354965

AUG102821

Details and patient eligibility

About

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.

Enrollment

52 patients

Sex

All

Ages

Under 16 years old

Volunteers

No Healthy Volunteers

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.