Clinical trial NCT00354965: Pharmacokinetic Profiles Of Amoxicillin 2000 mg And Clavulanate 125 mg In Adolescent Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infections, Respiratory Tract
Keywords: ABS
Acute Bacterial
Sinusitis
Bacterial Sinusitis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-07-20
Enrollment: 52
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Pharmacokinetic data on amoxicillin/clavulanate
timeFrame: Time above MIC (T>MIC)for amoxicillin when amoxicillin/clavulanate is given orally twice daily to adolescents.
Secondary outcomes:
measure: Safety, tolerability, and clinical response of oral amoxicillin/clavulanate
timeFrame: twice daily for 10 days in adolescent patients.
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Huntington Beach
country: United States
facility: GSK Investigational Site
state: California
city: North Dartmouth
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Sylva
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Erie
country: United States
facility: GSK Investigational Site
state: Pennsylvania
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: