Skin Infections, BacterialNCT01153880
United States Pharmacovigilence Retapamulin-Prescribing
An observational study of Skin Infections, Bacterial, 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 United States (US), retapamulin is approved for the treatment of impetigo in persons nine or more months of age and was launched on 12 April 2007. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Skin Infections, Bacterial
- What is being tested?
- Retapamulin and Co-prescription of retapamulin and topical mupirocin
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Dec 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: Members with enrollment and phamacy benefits eligibility in the Integrated Health Care Information Services (IHCIS) National Managed Care Benchmarked Database will be assessed annually for prescription sales claims for five years post-launch of retapamulin. The IHCIS is a US national managed care database which is Health Insurance Portability and Accountability Act (HIPAA) compliant and features encrypted member and provider identifiers.
Who may be able to join
- The study population will consist of all 'eligible members' in the IHCIS database with a valid gender and age record who have at least 1 month enrolment and eligibility of pharmacy benefits.
Who cannot join
- Membership in IHCIS without a valid gender or age record, enrolment less than 1 month, or ineligibility for pharmacy benefits will be excluded.
About this study
Official title: Pharmacovigilence for Retapamulin: Age-stratified Monitoring of Prescribed Use in the United States
Retapamulin, a topical pleuromutilin antibiotic, is the first in a new class of topical antibiotics approved for human use. In the United States (US), retapamulin is approved for the treatment of impetigo in persons nine or more months of age and was launched on 12 April 2007. This five-year study is designed to examine use of retapamulin in the pediatric population less than nine months of age. We will conduct an annual assessment of prescription sales claims for retapamulin using the Integrated Health Care Information Services (IHCIS) National Managed Care Benchmarked Database. For each year of reporting, the observed frequencies of the exposure, with or without same-day, co-prescribed sales claim of mupirocin, will be identified. The study objectives are to determine the frequency of retapamulin sales in a representative US population stratified by the designated age group and to determine the frequency of same-day sale of the topical agent, mupirocin.
Read the detailed description
The IHCIS is Health Insurance Portability and Accountability Act (HIPAA) compliant with encrypted member and provider identifiers; date of birth is restricted to year of birth. Based on year of birth and the prescription sales claim date, age at the time of the prescription(s) will be categorized as less than 9 months (definitive) and less than 9 months (uncertain).
- Conditions
- Skin Infections, Bacterial
- Being tested
- Retapamulin, Co-prescription of retapamulin and topical mupirocin
- Keywords
- Altabax, United States, topical, Mupirocin, Retapamulin, Bactroban
- Medical subject headings
- Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RetapamulinDrug
Prescription sales claim of retapamulin
Co-prescription of retapamulin and topical mupirocinDrug
Same day prescription sales claims for retapamulin and topical mupirocin
| Study group | Role | What they receive |
|---|---|---|
| Age <9 months definitive | Age at time of prescription was <9 months Receives: Drug: Retapamulin; Drug: Co-prescription of retapamulin and topical mupirocin | |
| Age <9 months uncertain | Age at time of prescription was uncertain for <9 months Receives: Drug: Retapamulin; Drug: Co-prescription of retapamulin and topical mupirocin | |
| 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 | |
| 7 to 18 years | Age at time of prescription was 7 to 18 years Receives: Drug: Retapamulin; Drug: Co-prescription of retapamulin and topical mupirocin | |
| 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 | |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prescription of retapamulin
Measured: First prescription in database for each calendar year between January 2007 and December 2011
Secondary outcomes (1)
Prescription for retapamulin and topical mupirocin
Measured: First same-day prescriptions for both medicines in database for each calendar year between Janaury 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 startDec 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 Skin Infections, BacterialStudies 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
- NCT01153880
- Sponsor's protocol ID
- 113158
- Status last verified
- May 2013
- First submitted
- 29 Jun 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 United States
- ClinicalTrials.gov ID
- NCT01153880
- Acronym / sponsor ID
- 113158
- Conditions
- Skin Infections, Bacterial
- Keywords
- Altabax, United States, topical, Mupirocin, Retapamulin, Bactroban
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 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 United States (US), retapamulin is approved for the treatment of impetigo in persons nine or more months of age and was launched on 12 April 2007. This five-year study is designed to examine use of retapamulin in the pediatric population less than nine months of age. We will conduct an annual assessment of prescription sales claims for retapamulin using the Integrated Health Care Information Services (IHCIS) National Managed Care Benchmarked Database. For each year of reporting, the observed frequencies of the exposure, with or without same-day, co-prescribed sales claim of mupirocin, will be identified. The study objectives are to determine the frequency of retapamulin sales in a representative US population stratified by the designated age group and to determine the frequency of same-day sale of the topical agent, mupirocin.
Detailed description
The IHCIS is Health Insurance Portability and Accountability Act (HIPAA) compliant with encrypted member and provider identifiers; date of birth is restricted to year of birth. Based on year of birth and the prescription sales claim date, age at the time of the prescription(s) will be categorized as less than 9 months (definitive) and less than 9 months (uncertain).
Study design
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Age <9 months definitive | – | Drug: Retapamulin, Drug: Co-prescription of retapamulin and topical mupirocinAge at time of prescription was <9 months |
| Age <9 months uncertain | – | Drug: Retapamulin, Drug: Co-prescription of retapamulin and topical mupirocinAge at time of prescription was uncertain for <9 months |
| 9 months to 6 years | – | Drug: Retapamulin, Drug: Co-prescription of retapamulin and topical mupirocinAge at time of prescription was 9 months to 6 years |
| 7 to 18 years | – | Drug: Retapamulin, Drug: Co-prescription of retapamulin and topical mupirocinAge at time of prescription was 7 to 18 years |
| 19 to 65 years | – | Drug: Retapamulin, Drug: Co-prescription of retapamulin and topical mupirocinAge at time of prescription was 19 to 65 years |
| 66 years and older | – | Drug: Retapamulin, Drug: Co-prescription of retapamulin and topical mupirocinAge 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
- Members with enrollment and phamacy benefits eligibility in the Integrated Health Care Information Services (IHCIS) National Managed Care Benchmarked Database will be assessed annually for prescription sales claims for five years post-launch of retapamulin. The IHCIS is a US national managed care database which is Health Insurance Portability and Accountability Act (HIPAA) compliant and features encrypted member and provider identifiers.
Key inclusion criteria (1 listed)
- The study population will consist of all 'eligible members' in the IHCIS database with a valid gender and age record who have at least 1 month enrolment and eligibility of pharmacy benefits.
Key exclusion criteria (1 listed)
- Membership in IHCIS without a valid gender or age record, enrolment less than 1 month, or ineligibility for pharmacy benefits will be excluded.
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 sales claim of retapamulin | Drug | 19 to 65 years, 66 years and older, 7 to 18 years, 9 months to 6 years, Age <9 months definitive, Age <9 months uncertain |
| Co-prescription of retapamulin and topical mupirocinSame day prescription sales claims for retapamulin and topical mupirocin | Drug | 19 to 65 years, 66 years and older, 7 to 18 years, 9 months to 6 years, Age <9 months definitive, Age <9 months uncertain |
Primary outcome
Prescription of retapamulin
Time frame: First prescription in database for each calendar year between January 2007 and December 2011
1 secondary outcome
Prescription for retapamulin and topical mupirocin
Time frame: First same-day prescriptions for both medicines in database for each calendar year between Janaury 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 Skin Infections, Bacterial, 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 of 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.