Skin Infections, BacterialPhase 4NCT00555061
Pharmacokinetics of Retapamulin in Pediatric Subjects With Uncomplicated Skin Infections.
A Phase 4 study testing Retapamulin Ointment, 1% in people with Skin Infections, Bacterial, run by GlaxoSmithKline at 25 sites in 9 countries.
Trial summary
A study to evaluate the pharmacokinetics of Retapamulin Ointment, 1%, in pediatric subjects (2-24 months) with secondarily-infected traumatic lesions, secondarily-infected dermatoses, or impetigo (bullous and non-bullous). Read more about this study
- Who is it for?
- Ages 2 to 24 months
- Conditions the study is for
- Skin Infections, Bacterial
- What is being tested?
- Retapamulin Ointment, 1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 25 sitesin 9 countries
- Study dates
- Sep 2007to Aug 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject Age: The subject is ≥2 months to ≤24 months of age at study entry
- Subject Diagnosis: The subject has a diagnosis of secondarily-infected traumatic lesion (SITL), secondarily-infected dermatoses (SID), or primary impetigo (bullous or non-bullous) that is suitable for treatment with topical antibacterial therapy:
- The subject has a small laceration, sutured wound or abrasion, which has a secondary bacterial infection. The infected portion of the laceration or sutured wound should not exceed 10cm in length with surrounding erythema not extending more than 2cm from the edge of the wound. Abrasions should not exceed 2% of the total body surface area with surrounding erythema not extending more than 2cm from the edge of the abrasion.
- The subject has a diagnosis of inflammatory skin disease (i.e., dermatosis), such as atopic dermatitis or contact dermatitis, which has a secondary bacterial infection. The infected portion of the lesion(s) should not exceed 2% of the total body surface area.
- Impetigo: The subject has a lesion or group of £10 discrete localized lesions on otherwise healthy skin, characterized by red spots or blisters without crusts which later progress to lesions which ooze and form yellow or honey-colored crusts surrounded by an erythematous margin.
- Subject SIRS Score: The subject has a total SIRS score of at least 8 (Appendix 1 Skin Infection Rating Scale)
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- Protocol Compliance: The parent/legal guardian is willing to comply with the protocol
- Informed Consent: The parent/legal guardian has given written informed, dated consent for the subject to participate in the study
- French Subjects: In France, a subject will be eligible for inclusion in this study if either affiliated to or a beneficiary of a social security category
Who cannot join
- The subject has demonstrated a previous hypersensitivity reaction to pleuromutilin or any component of the ointment (refer to the Investigator Brochure for composition of Retapamulin ointment, 1%)
- The subject was considered to be premature at birth (<37 weeks gestation)
- The subject has a secondarily-infected animal/human bite, or a puncture wound
- The subject has an abscess
- The subject has a chronic ulcerative lesion that is unlikely to have Staphylococcus aureus or Streptococcus pyogenes as the causative agent
- The subject has systemic signs and symptoms of infection (such as fever; defined as a temperature equivalent to a rectal temperature greater than 101°F or 38.3°C)
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- The subject has a bacterial skin infection which, due to area, depth or severity, in the opinion of the investigator, cannot be appropriately treated by a topical antibiotic
- The subject has more than one type of infected lesion as defined in the protocol
- The subject requires surgical intervention for treatment of the infection prior to enrollment in the study, or is likely to require such intervention during the course of the study
- The subject has applied any topical therapeutic agent (including glucocorticoid steroids, antibacterials or antifungals) directly to the infected wound/lesion, within 24 hours prior to study entry
- The subject has received one or more days of treatment with a systemic antibacterial within 72 hours of study entry
- The subject is receiving systemic corticosteroids at a dose of >0.125mg/kg per day of prednisone (or the equivalent)
- The subject has a known, pre-existing, serious underlying disease that could be imminently life-threatening
- The subject has participated in any study using an investigational drug during the previous 30 days prior to entering the study
- The subject has been previously enrolled in this study or in any other study involving Retapamulin
Trial locations and contacts
25 sites in 9 countries.
25 sites in 9 countries
United States6 sites
GSK Investigational Site
Bentonville, Arkansas, 72712
GSK Investigational Site
Cleveland, Ohio, 44106
GSK Investigational Site
Houston, Texas, 77090
GSK Investigational Site
Orange, California, 92868
GSK Investigational Site
Tuscaloosa, Alabama, 35401
GSK Investigational Site
Woburn, Massachusetts, 01801
Netherlands6 sites
GSK Investigational Site
Alphen aan den Rijn, 2403 JK
GSK Investigational Site
Losser, 7581 BV
GSK Investigational Site
Roelofarendsveen, 2371 RB
GSK Investigational Site
Rotterdam, 3011 TD
GSK Investigational Site
Soerendonk, 6027 RN
GSK Investigational Site
Woerden, 3443 GG
Germany5 sites
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44791
GSK Investigational Site
Erkrath, North Rhine-Westphalia, 40699
GSK Investigational Site
Goch, North Rhine-Westphalia, 47574
GSK Investigational Site
Kleve-Materborn, North Rhine-Westphalia, 47533
GSK Investigational Site
Nördlingen, Bavaria, 86720
Argentina2 sites
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425BEA
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires
South Africa2 sites
GSK Investigational Site
Benoni, 1501
GSK Investigational Site
Newtown, 2113
Chile1 site
GSK Investigational Site
Santiago, Región Metro de Santiago, 7580206
About this study
Official title: An Open-Label, Non-Comparative Study to Assess the Pharmacokinetics, Safety and Efficacy of Topical Retapamulin (SB-275833) Ointment, 1%, Twice Daily for Five Days in the Treatment of Uncomplicated Skin and Skin Structure Infections in Pediatric Subjects Aged 2 to 24 Months
A study to evaluate the pharmacokinetics of Retapamulin Ointment, 1%, in pediatric subjects (2-24 months) with secondarily-infected traumatic lesions, secondarily-infected dermatoses, or impetigo (bullous and non-bullous).
- Conditions
- Skin Infections, Bacterial
- Being tested
- Retapamulin Ointment, 1%
- Keywords
- SID, impetigo, pharmacokinetics, Retapamulin ointment, 1%, Skin abnormalities, Dermatoses, pediatric, infection, SITL
- Medical subject headings
- Cellulitis, Sudden Infant Death, Impetigo, Skin Abnormalities, Skin Diseases, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retapamulin Ointment, 1%Drug
Also called Retapamulin Ointment, 1%
1% Ointment
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Single Arm Retapamulin 1% Ointment Receives: Drug: Retapamulin Ointment, 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Measurable Plasma Concentrations, by Age Group
Pharmacokinetic (PK) samples were collected randomly in the window of 4 to 8 hours post-dose (except one at 3 hours and one at 11 hours post-dose) after the first daily dose of treatment on Day 3 or Day 4. The lower limit of quantification (LLQ) for retapamulin was 0.5 ng/mL.
Measured: Days 3 to 4; 4 to 8 hours post-dose of the first dose of the day
Secondary outcomes (3)
Number of Participants With Clinical Success at Follow-up, by Type of Skin Infection and by Age
SID = Secondarily Infected Dermatoses; SITL = Secondarily Infected Traumatic Lesions. Clinical Success is the number of participants with resolution of signs/symptoms of infection or improvement such that no additional antibiotic therapy was needed.
Measured: Follow-up, Days 12 to 16
Bacteriological Success Rate at Follow-up, by Baseline Pathogen
Bacteriological success is defined as: (1) Bacteriological Eradication, elimination of the baseline pathogen via culture results; (2) Presumed Bacteriological Eradication, clinical success plus no culturable material from the wound; or (3) Colonization, new pathogen identified at Follow-up in a non-symptomatic participant who does not require additional antibiotic therapy. The number of pathogens eradicated out of the number isolated (shown as "n" in the category title) for each respective category is shown.
Measured: Follow-up, Days 12 to 16
Number of Participants by Age With Therapeutic Response of Success
Therapeutic response is a measure of the overall efficacy response; a response of "therapeutic success" was based on both clinical success and bacteriological success in a given participant.
Measured: Follow-up, Days 12 to 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2007 (estimated)
- Study startSep 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT00555061
- Sponsor's protocol ID
- TOC106489
- Status last verified
- Nov 2016
- First submitted
- 6 Nov 2007
- Last updated
- 28 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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 28 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Non-Comparative Study to Assess the Pharmacokinetics, Safety and Efficacy of Topical Retapamulin (SB-275833) Ointment, 1%, Twice Daily for Five Days in the Treatment of Uncomplicated Skin and Skin Structure Infections in Pediatric Subjects Aged 2 to 24 Months
- ClinicalTrials.gov ID
- NCT00555061
- Acronym / sponsor ID
- TOC106489
- Conditions
- Skin Infections, Bacterial
- Keywords
- SID, impetigo, pharmacokinetics, Retapamulin ointment, 1%, Skin abnormalities, Dermatoses, pediatric, infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 7 Nov 2007 (estimated)
- Results
- Posted 30 Apr 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to evaluate the pharmacokinetics of Retapamulin Ointment, 1%, in pediatric subjects (2-24 months) with secondarily-infected traumatic lesions, secondarily-infected dermatoses, or impetigo (bullous and non-bullous).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Retapamulin Ointment, 1%Single Arm Retapamulin 1% Ointment |
Who may qualify
- Ages
- 2 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Subject Age: The subject is ≥2 months to ≤24 months of age at study entry
- Subject Diagnosis: The subject has a diagnosis of secondarily-infected traumatic lesion (SITL), secondarily-infected dermatoses (SID), or primary impetigo (bullous or non-bullous) that is suitable for treatment with topical antibacterial therapy:
- The subject has a small laceration, sutured wound or abrasion, which has a secondary bacterial infection. The infected portion of the laceration or sutured wound should not exceed 10cm in length with surrounding erythema not extending more than 2cm from the edge of the wound. Abrasions should not exceed 2% of the total body surface area with surrounding erythema not extending more than 2cm from the edge of the abrasion.
- The subject has a diagnosis of inflammatory skin disease (i.e., dermatosis), such as atopic dermatitis or contact dermatitis, which has a secondary bacterial infection. The infected portion of the lesion(s) should not exceed 2% of the total body surface area.
- Impetigo: The subject has a lesion or group of £10 discrete localized lesions on otherwise healthy skin, characterized by red spots or blisters without crusts which later progress to lesions which ooze and form yellow or honey-colored crusts surrounded by an erythematous margin.
Key exclusion criteria (15 listed)
- The subject has demonstrated a previous hypersensitivity reaction to pleuromutilin or any component of the ointment (refer to the Investigator Brochure for composition of Retapamulin ointment, 1%)
- The subject was considered to be premature at birth (<37 weeks gestation)
- The subject has a secondarily-infected animal/human bite, or a puncture wound
- The subject has an abscess
- The subject has a chronic ulcerative lesion that is unlikely to have Staphylococcus aureus or Streptococcus pyogenes as the causative agent
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 |
|---|---|---|
| Retapamulin Ointment, 1%Also: Retapamulin Ointment, 1%1% Ointment | Drug | Arm 1 |
Primary outcome
Number of Participants With Measurable Plasma Concentrations, by Age Group
Time frame: Days 3 to 4; 4 to 8 hours post-dose of the first dose of the day
Pharmacokinetic (PK) samples were collected randomly in the window of 4 to 8 hours post-dose (except one at 3 hours and one at 11 hours post-dose) after the first daily dose of treatment on Day 3 or Day 4. The lower limit of quantification (LLQ) for retapamulin was 0.5 ng/mL.
3 secondary outcomes
Number of Participants With Clinical Success at Follow-up, by Type of Skin Infection and by Age
Time frame: Follow-up, Days 12 to 16
Bacteriological Success Rate at Follow-up, by Baseline Pathogen
Time frame: Follow-up, Days 12 to 16
Number of Participants by Age With Therapeutic Response of Success
Time frame: Follow-up, Days 12 to 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- 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
25 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Retapamulin Ointment, 1% in people with Skin Infections, Bacterial, run by GlaxoSmithKline at 25 sites in 9 countries.
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 9 inclusion and 15 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 28 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Netherlands, Germany, Argentina, South Africa and 4 more countries. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Apr 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Measurable Plasma Concentrations, by Age Group (time frame: Days 3 to 4; 4 to 8 hours post-dose of the first dose of the day). 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 28 Dec 2016.