ImpetigoNCT01153828
EU PV for Retapamulin-Prescribing
An observational study of Impetigo, run by GlaxoSmithKline.
Trial summary
Retapamulin, a topical pleuromutilin antibiotic, is the first in a new class of topical antibiotics approved for human use. In the European Union (EU), retapamulin is approved for the treatment of impetigo and secondarily-infected traumatic lesions in persons nine or more months of age. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Impetigo
- What is being tested?
- Retapamulin, Co-prescription of retapamulin and topical mupirocin and Co-prescription of retapamulin and topical fusidic acid
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to Aug 2012
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The GPRD contains detailed information for a sample of patients from representative general practices throughout the United Kingdom. Patient data included in the GPRD were drawn from the computer systems used by general practitioners to maintain the clinical records within their practices and contain all records deemed relevant to patient care. Prescriptions of Altabax, Altargo, Mupirocin and Fucidin will be captured.
Who may be able to join
- The study population will consist of all registered "research standard" patients on GPRD, as evaluated annually for five years. For each year of observation, the denominator of persons will be patients registered for at least one month during the prior calendar year. Hence, the five-year reporting period for distinct, non-overlapping, non-cumulative prescription use and will categorize persons by date of birth (mm/dd/year).
Who cannot join
- Enrollment in GPRD of less than one month duration.
About this study
Official title: Pharmacovigilence for Retapamulin: Age-stratified Monitoring of Prescribed Use in the European Union
Retapamulin, a topical pleuromutilin antibiotic, is the first in a new class of topical antibiotics approved for human use. In the European Union (EU), retapamulin is approved for the treatment of impetigo and secondarily-infected traumatic lesions in persons nine or more months of age. This study is designed to examine retapamulin use in the pediatric population less than nine months of age. We will conduct a five-year assessment of prescriptions for retapamulin using the General Practice Research Database. For each year of reporting, the observed frequencies of prescriptions of retapamulin, with or without same-day co-prescriptions of topical mupirocin or fusidic acid, will be identified. The five-year reporting period will include five years of distinct, non-overlapping, non-cumulative prescription use of first exposure to retapamulin, with or without same-day co-prescription of topical mupirocin or fusidic acid.
- Conditions
- Impetigo
- Being tested
- Retapamulin, Co-prescription of retapamulin and topical mupirocin, Co-prescription of retapamulin and topical fusidic acid
- Keywords
- Altargo, Bactroban, Fucidin, Fusidic acid, Mupirocin, topical, Retapamulin, United Kingdom
- Medical subject headings
- Impetigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RetapamulinDrug
Prescription for retapamulin
Co-prescription of retapamulin and topical mupirocinDrug
Same day prescriptions for retapamulin and topical mupirocin
Co-prescription of retapamulin and topical fusidic acidDrug
Same day prescription for retapamulin and fusidic acid.
| Study group | Role | What they receive |
|---|---|---|
| (1) Age <9 months | Age at time of prescription was <9 months Receives: Drug: Retapamulin; Drug: Co-prescription of retapamulin and topical mupirocin; Drug: Co-prescription of retapamulin and topical fusidic acid | |
| (2) 9 months to 6 years | Age at time of prescription was 9 months to 6 years Receives: Drug: Retapamulin; Drug: Co-prescription of retapamulin and topical mupirocin; Drug: Co-prescription of retapamulin and topical fusidic acid | |
| (3) 7 years to 18 years | Age at time of prescription was 7 years to 18 years Receives: Drug: Retapamulin; Drug: Co-prescription of retapamulin and topical mupirocin; Drug: Co-prescription of retapamulin and topical fusidic acid | |
| (4) 19 to 65 years | Age at time of prescription was 19 to 65 years Receives: Drug: Retapamulin; Drug: Co-prescription of retapamulin and topical mupirocin; Drug: Co-prescription of retapamulin and topical fusidic acid | |
| (5) 66 years and older | Age at time of prescription was 66 years and older Receives: Drug: Retapamulin; Drug: Co-prescription of retapamulin and topical mupirocin; Drug: Co-prescription of retapamulin and topical fusidic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prescription for retapamulin
Measured: First prescription in database for each calendar year between January 2007 and December 2011
Secondary outcomes (2)
Co-prescription of retapamulin and topical mupirocin
Measured: First same-day prescriptions for both medicines in database for each calendar year between January 2007 and December 2011
Co-prescription of retapamulin and topical fusidic acid
Measured: First same-day prescriptons for both medicines in database for each calendar year between January 2007 and December 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2010 (estimated)
- Study startNov 2008
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImpetigoStudies 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 1 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
- NCT01153828
- Sponsor's protocol ID
- 113149
- Status last verified
- May 2013
- First submitted
- 13 May 2010
- Last updated
- 10 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacovigilence for Retapamulin: Age-stratified Monitoring of Prescribed Use in the European Union
- ClinicalTrials.gov ID
- NCT01153828
- Acronym / sponsor ID
- 113149
- Conditions
- Impetigo
- Keywords
- Altargo, Bactroban, Fucidin, Fusidic acid, Mupirocin, topical, Retapamulin, United Kingdom
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 30 Jun 2010 (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.
Retapamulin, a topical pleuromutilin antibiotic, is the first in a new class of topical antibiotics approved for human use. In the European Union (EU), retapamulin is approved for the treatment of impetigo and secondarily-infected traumatic lesions in persons nine or more months of age. This study is designed to examine retapamulin use in the pediatric population less than nine months of age. We will conduct a five-year assessment of prescriptions for retapamulin using the General Practice Research Database. For each year of reporting, the observed frequencies of prescriptions of retapamulin, with or without same-day co-prescriptions of topical mupirocin or fusidic acid, will be identified. The five-year reporting period will include five years of distinct, non-overlapping, non-cumulative prescription use of first exposure to retapamulin, with or without same-day co-prescription of topical mupirocin or fusidic acid.
Study design
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| (1) Age <9 months | – | Drug: Retapamulin, Drug: Co-prescription of retapamulin and topical mupirocin, Drug: Co-prescription of retapamulin and topical fusidic acidAge at time of prescription was <9 months |
| (2) 9 months to 6 years | – | Drug: Retapamulin, Drug: Co-prescription of retapamulin and topical mupirocin, Drug: Co-prescription of retapamulin and topical fusidic acidAge at time of prescription was 9 months to 6 years |
| (3) 7 years to 18 years | – | Drug: Retapamulin, Drug: Co-prescription of retapamulin and topical mupirocin, Drug: Co-prescription of retapamulin and topical fusidic acidAge at time of prescription was 7 years to 18 years |
| (4) 19 to 65 years | – | Drug: Retapamulin, Drug: Co-prescription of retapamulin and topical mupirocin, Drug: Co-prescription of retapamulin and topical fusidic acidAge at time of prescription was 19 to 65 years |
| (5) 66 years and older | – | Drug: Retapamulin, Drug: Co-prescription of retapamulin and topical mupirocin, Drug: Co-prescription of retapamulin and topical fusidic acidAge at time of prescription was 66 years and older |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The GPRD contains detailed information for a sample of patients from representative general practices throughout the United Kingdom. Patient data included in the GPRD were drawn from the computer systems used by general practitioners to maintain the clinical records within their practices and contain all records deemed relevant to patient care. Prescriptions of Altabax, Altargo, Mupirocin and Fucidin will be captured.
Key inclusion criteria (1 listed)
- The study population will consist of all registered "research standard" patients on GPRD, as evaluated annually for five years. For each year of observation, the denominator of persons will be patients registered for at least one month during the prior calendar year. Hence, the five-year reporting period for distinct, non-overlapping, non-cumulative prescription use and will categorize persons by date of birth (mm/dd/year).
Key exclusion criteria (1 listed)
- Enrollment in GPRD of less than one month duration.
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 |
|---|---|---|
| RetapamulinPrescription for retapamulin | Drug | (1) Age <9 months, (2) 9 months to 6 years, (3) 7 years to 18 years, (4) 19 to 65 years, (5) 66 years and older |
| Co-prescription of retapamulin and topical mupirocinSame day prescriptions for retapamulin and topical mupirocin | Drug | (1) Age <9 months, (2) 9 months to 6 years, (3) 7 years to 18 years, (4) 19 to 65 years, (5) 66 years and older |
| Co-prescription of retapamulin and topical fusidic acidSame day prescription for retapamulin and fusidic acid. | Drug | (1) Age <9 months, (2) 9 months to 6 years, (3) 7 years to 18 years, (4) 19 to 65 years, (5) 66 years and older |
Primary outcome
Prescription for retapamulin
Time frame: First prescription in database for each calendar year between January 2007 and December 2011
2 secondary outcomes
Co-prescription of retapamulin and topical mupirocin
Time frame: First same-day prescriptions for both medicines in database for each calendar year between January 2007 and December 2011
Co-prescription of retapamulin and topical fusidic acid
Time frame: First same-day prescriptons for both medicines in database for each calendar year between January 2007 and December 2011
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 10 Jun 2013.
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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
Questions about this trial
What is this clinical trial studying?
An observational study of Impetigo, run by GlaxoSmithKline.
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 1 inclusion and 1 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 10 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Prescription for retapamulin (time frame: First prescription in database for each calendar year between January 2007 and December 2011). 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 10 Jun 2013.