Status:
COMPLETED
Pharmacokinetic Profiles Of Amoxicillin 2000 mg And Clavulanate 125 mg In Adolescent Patients
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Respiratory Tract
Eligibility:
All Genders
Up to 16 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 19 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2007
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00354965
Start Date
January 19 2006
End Date
April 2 2007
Last Update
August 1 2017
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Little Rock, Arkansas, United States, 72202
2
GSK Investigational Site
Huntington Beach, California, United States, 92647
3
GSK Investigational Site
North Dartmouth, Massachusetts, United States, 02747
4
GSK Investigational Site
Sylva, North Carolina, United States, 28779