Infections, Respiratory TractPhase 1NCT00354965
Pharmacokinetic Profiles Of Amoxicillin 2000 mg And Clavulanate 125 mg In Adolescent Patients
A Phase 1 study testing amoxicillin/clavulanate potassium in people with Infections, Respiratory Tract, run by GlaxoSmithKline at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Infections, Respiratory Tract
- What is being tested?
- amoxicillin/clavulanate potassium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 6 sitesUnited States
- Study dates
- 19 Jan 2006to 2 Apr 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
GSK Investigational Site
Cleveland, Ohio, 44106
GSK Investigational Site
Erie, Pennsylvania, 16506
GSK Investigational Site
Huntington Beach, California, 92647
GSK Investigational Site
Little Rock, Arkansas, 72202
GSK Investigational Site
North Dartmouth, Massachusetts, 02747
GSK Investigational Site
Sylva, North Carolina, 28779
About this study
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
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
- Being tested
- amoxicillin/clavulanate potassium
- Keywords
- ABS, Acute Bacterial, Sinusitis, Bacterial Sinusitis
- Medical subject headings
- Respiratory Tract Infections, Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amoxicillin/clavulanate potassiumDrug
amoxicillin/clavulanate potassium
| Study group | Role | What they receive |
|---|---|---|
| ARM 1 | Experimental | Not described Receives: Drug: amoxicillin/clavulanate potassium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic data on amoxicillin/clavulanate
Measured: 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
Measured: twice daily for 10 days in adolescent patients.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2006 (estimated)
- Study start19 Jan 2006
- Primary completion2 Apr 2007
- Study completion2 Apr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections, Respiratory TractStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00354965
- Sponsor's protocol ID
- AUG102821
- Status last verified
- Jul 2017
- First submitted
- 18 Jul 2006
- Last updated
- 1 Aug 2017
- Results posted
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00354965
- Acronym / sponsor ID
- AUG102821
- Conditions
- Infections, Respiratory Tract
- Keywords
- ABS, Acute Bacterial, Sinusitis, Bacterial Sinusitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2006 (actual)
- Primary completion
- 2 Apr 2007 (actual)
- Study completion
- 2 Apr 2007 (actual)
- First posted
- 20 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARM 1 | Experimental | Drug: amoxicillin/clavulanate potassium |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amoxicillin/clavulanate potassiumamoxicillin/clavulanate potassium | Drug | ARM 1 |
Primary outcome
Pharmacokinetic data on amoxicillin/clavulanate
Time frame: Time above MIC (T>MIC)for amoxicillin when amoxicillin/clavulanate is given orally twice daily to adolescents.
1 secondary outcome
Safety, tolerability, and clinical response of oral amoxicillin/clavulanate
Time frame: twice daily for 10 days in adolescent patients.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Results for study AUG102821 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing amoxicillin/clavulanate potassium in people with Infections, Respiratory Tract, run by GlaxoSmithKline at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic data on amoxicillin/clavulanate (time frame: Time above MIC (T>MIC)for amoxicillin when amoxicillin/clavulanate is given orally twice daily to adolescents.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017.