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



Status:Completed
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any - 16
Updated:8/2/2017
Start Date:January 19, 2006
End Date:April 2, 2007

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

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.


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.
We found this trial at
6
sites
Erie, Pennsylvania 16507
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Erie, PA
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Cleveland, Ohio 44195
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Cleveland, OH
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Huntington Beach, California 92647
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Huntington Beach, CA
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Little Rock, Arkansas 72205
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Little Rock, AR
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North Dartmouth, Massachusetts 02747
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North Dartmouth, MA
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Sylva, North Carolina 28779
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Sylva, NC
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