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Skin Infections, BacterialPhase 3NCT00684177

Retapamulin Versus Placebo in Secondarily-Infected Traumatic Lesions (SITL)

A Phase 3 study testing Retapamulin Ointment, 1% in people with Skin Infections, Bacterial, run by GlaxoSmithKline at 54 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of Study TOC110977 is to demonstrate clinical superiority of Retapamulin ointment, 1%, over placebo in patients with secondarily-infected traumatic lesions, which includes secondarily-infected lacerations, abrasions and sutured wounds. Read more about this study

Who is it for?
Ages 2 months and older
Conditions the study is for
Skin Infections, Bacterial
What is being tested?
Retapamulin Ointment, 1%
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
508 participants
Where
54 sitesin 5 countries
Study dates
May 2008to Oct 2009
Phase
Phase 3
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 months and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • subject is aged 2 months or older
  • subject has secondarily-infected traumatic lesion (laceration, sutured wound or abrasion)
  • negative urine pregnancy test
  • subject has total skin infection rating scale score of at least 8, including pus/exudate score of at least 3
  • subject and/or parent/legal guardian is willing and able to comply with protocol
  • subject or parent/legal guardian has given written informed consent or assent as applicable

Who cannot join

  • previous hypersensitivity to pleuromutilin
  • secondarily-infected animal/human bite or puncture wound
  • subject has an abscess
  • chronic ulcerative lesion
  • underlying skin disease
  • systemic signs and symptoms of infection
Show all 13Show fewer
  • infection not appropriately treated with topical antibiotic
  • infection requires surgical intervention prior to or during study
  • subject received systemic antibacterial or steroid, or topical therapeutic agent within 24 hours of entry into study
  • serious underlying disease
  • subject pregnant, breast feeding or planning a pregnancy, or unacceptable method of contraception
  • other investigational drug within 30 days of study entry
  • subject previously enrolled in this study

Trial locations and contacts

54 sites in 5 countries.

54 sites in 5 countries

United States32 sites

  • GSK Investigational Site

    Anaheim, California, 92804

  • GSK Investigational Site

    Arlington Heights, Illinois, 60005

  • GSK Investigational Site

    Bountiful, Utah, 84010

  • GSK Investigational Site

    Brooklyn, New York, 11218

  • GSK Investigational Site

    Brooklyn, New York, 11229

  • GSK Investigational Site

    Butte, Montana, 59701

  • GSK Investigational Site

    Cincinnati, Ohio, 45246

  • GSK Investigational Site

    Colorado Springs, Colorado, 80904

  • GSK Investigational Site

    Deerfield Beach, Florida, 33441

  • GSK Investigational Site

    East Syracuse, New York, 13057

  • GSK Investigational Site

    Fresno, California, 93710

  • GSK Investigational Site

    Greenville, South Carolina, 29615

  • GSK Investigational Site

    Hollywood, Florida, 33023

  • GSK Investigational Site

    Houston, Texas, 77036

  • GSK Investigational Site

    Irvine, California, 90620

  • GSK Investigational Site

    Johnson City, New York, 13790

  • GSK Investigational Site

    Kansas City, Kansas, 66160

  • GSK Investigational Site

    Los Angeles, California, 90048

  • GSK Investigational Site

    Miami, Florida, 33144

  • GSK Investigational Site

    Miami, Florida, 33155

  • GSK Investigational Site

    New Orleans, Louisiana, 70112

  • GSK Investigational Site

    Norristown, Pennsylvania, 19401

  • GSK Investigational Site

    Orlando, Florida, 32712

  • GSK Investigational Site

    Panama City, Florida, 32401

  • GSK Investigational Site

    Sacramento, California, 95825

  • GSK Investigational Site

    Tampa, Florida, 33606

  • GSK Investigational Site

    Teaneck, New Jersey, 07666

  • GSK Investigational Site

    Tucson, Arizona, 85705

  • GSK Investigational Site

    Uniontown, Pennsylvania, 15401

  • GSK Investigational Site

    Vero Beach, Florida, 32960

  • GSK Investigational Site

    Vienna, Virginia, 22180

  • GSK Investigational Site

    West Palm Beach, Florida, 33401

Other trials in United States

South Africa10 sites

  • GSK Investigational Site

    Belville, 7530

  • GSK Investigational Site

    Benoni, 1501

  • GSK Investigational Site

    Cape Town, 7572

  • GSK Investigational Site

    Cape Town

  • GSK Investigational Site

    Hatfield, 83

  • GSK Investigational Site

    Lynnwood, 81

  • GSK Investigational Site

    Midrand, 1

  • GSK Investigational Site

    Newton, 6045

  • GSK Investigational Site

    Welkom, 9460

  • GSK Investigational Site

    Worcester, 6850

Other trials in South Africa

India5 sites

  • GSK Investigational Site

    Bangalore, 560002

  • GSK Investigational Site

    Lucknow, 226003

  • GSK Investigational Site

    Pune

  • GSK Investigational Site

    Vadodara, 390001

  • GSK Investigational Site

    Wardha, 442102

Other trials in India

Argentina4 sites

  • GSK Investigational Site

    Buenos Aires, Buenos Aires, CP1431FWO

  • GSK Investigational Site

    Buenos Aires, C1180AAX

  • GSK Investigational Site

    Chivilocoy, Buenos Aires, 6620

  • GSK Investigational Site

    Loma Hermosa, Buenos Aires, 1657

Other trials in Argentina

Brazil3 sites

  • GSK Investigational Site

    Curitiba, Paraná, 80240-280

  • GSK Investigational Site

    Curitiba/Paraná, Paraná, 80810-050

  • GSK Investigational Site

    Passo Fundo, Rio Grande do Sul, 99010-080

Other trials in Brazil

About this study

Official title: A Randomized, Double-Blind, Multicenter, Placebo-controlled, Phase III Superiority Study to Assess the Safety and Efficacy of Topical Retapamulin Ointment, 1%, Versus Placebo Ointment Applied Twice Daily for 5 Days in the Treatment of Adult and Pediatric Subjects With SITL

The purpose of Study TOC110977 is to demonstrate clinical superiority of Retapamulin ointment, 1%, over placebo in patients with secondarily-infected traumatic lesions, which includes secondarily-infected lacerations, abrasions and sutured wounds. Subjects 2 months of age and older will be treated with topical retapamulin or placebo ointment twice daily for 5 days. The primary endpoint of this study is the clinical response at follow-up (Day 12-14; 7-9 days after the end of therapy) in the intent-to-treat clinical population.

Read the detailed description

This is a prospective, multicenter, double-blind, placebo-controlled parallel group study in subjects aged 2 months and older with SITL, including secondarily-infected lacerations, sutured wounds or abrasions. A laceration or sutured wound cannot exceed 10 cm in length with surrounding erythema not extending more than 2 cm from the edge of the lesion. Abrasions cannot exceed 100 cm2 in total area, or up to a maximum of 2% total body surface area for subjects <18 years of age, with surrounding erythema not extending more than 2 cm from the edge of the abrasion.

There are four study visits occurring over a 12-14 day period. At the Baseline visit (Visit 1, Day 1), subjects will be randomized to receive retapamulin or placebo ointment in a 2:1 (retapamulin:placebo) ratio. The 2:1 randomization is included to minimize the number of subjects exposed to treatment with placebo. Both active treatment and placebo will be dosed topically twice daily (BID) for 5 days. All subjects will receive a telephone call from the investigator or appropriate designee appointed by the investigator on Day 2. The subject will be interviewed to determine if there is any evidence of worsening infection. Subjects who are thought to be worsening will be instructed to come in to the clinic for an assessment. Subjects will be monitored and clinically evaluated at the On-therapy (Days 3-4), End of Therapy (Days 7-9), and Follow-up (Days 12-14) visits.

Randomization will be center-based and performed using an appropriate Interactive Voice Response System (IVRS), an automated telephone system. The block size will remain confidential.

Subjects are considered to have completed the study if they meet all inclusion/exclusion criteria, are considered compliant with study medication, and attend all study visits as defined by the protocol.

Being tested
Retapamulin Ointment, 1%, Placebo ointment
Keywords
infection, retapamulin, secondarily-infected traumatic lesions, placebo
Medical subject headings
Cellulitis, 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%

    Provided as approximately 10 grams of an off-white smooth ointment in collapsible aluminum tubes with reverse taper puncture tip caps.

  • Placebo ointmentDrug

    Provided as approximately 10 grams of an off-white smooth ointment in collapsible aluminum tubes with reverse taper puncture tip caps.

Study groups in NCT00684177
Study groupRoleWhat they receive
Retapamulin Ointment, 1%ExperimentalNot described
Receives: Drug: Retapamulin Ointment, 1%
Placebo OintmentPlacebo comparatorNot described
Receives: Drug: Placebo ointment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Clinical Success and Failure at Follow-up (7-9 Days Post Therapy) for the Primary Efficacy Population

    "Clinical Success" at follow-up was defined as "Resolution of clinically meaningful signs and symptoms of infection recorded at baseline including a pus/exudate Skin Infection Rating Scale (SIRS) score of "0". Clinical response at follow-up was classified as "Clinical Failure" for all other cases. The SIRS consists of seven items (pus/exudates, crusting, erythema/inflammation, tissue warmth, tissue edema, itching and pain). Each item has a score ranging from 0 to 6 (0=absent, 6=severe). The SIRS total score was calculated as the sum of the scores of all 7 SIRS items.

    Measured: Days 12-14

Secondary outcomes (5)

  1. Number of Participants With Clinical Success and Failure at Follow-up (7-9 Days Post Therapy) for the Intent-to-Treat Bacteriology (ITTB) Subset of the Primary Efficacy Population

    "Clinical Success" at follow-up was defined as "Resolution of clinically meaningful signs and symptoms of infection recorded at baseline including a pus/exudate Skin Infection Rating Scale (SIRS) score of "0". Clinical response at follow-up was classified as "Clinical Failure" for all other cases. The SIRS consists of seven items (pus/exudates, crusting, erythema/inflammation, tissue warmth, tissue edema, itching and pain). Each item has a score ranging from 0 to 6 (0=absent, 6=severe). The SIRS total score was calculated as the sum of the scores of all 7 SIRS items.

    Measured: Days 12-14

  2. Number of Participants With Microbiological Success and Failure at Follow-up (7-9 Days Post Therapy)

    The "by pathogen" microbiological outcome was determined by comparing the baseline culture results to those at follow-up. The "by subject" microbiological response was "Microbiological Success" if the microbiological outcomes for all baseline pathogens (bps) belong to "Eradication" (elimination of bps), "Presumed Eradication" (clinical outcome was success; no culture was obtained due to lack of culturable material), or "Colonization" (previously unidentified pathogen is identified at end of therapy in participant who is resolved/improved); otherwise, response was "Microbiological Failure".

    Measured: Days 12-14

  3. Number of Participants With the Indicated Clinical Outcome at End of Therapy (2-4 Days Post Therapy)

    Clinical outcome is determined by the investigator based on signs and symptoms (S/S) at the end of therapy evaluation. The 4 clincal outcome categories are: clinical success, resolution of clinically meaningful S/S of infection recorded at baseline (BL), including a pus/exudates score of 0; clinical improvement, improvement of S/S of infection recorded at BL to such an extent that no further antimicrobial therapy is necessary; clinical failure, insufficient improvement of deterioration of S/S of infection recorded at BL such that additional antibiotic therapy is required; unable to determine.

    Measured: Days 7-9

  4. Number of Baseline Pathogens With the Indicated Microbiological Outcome at End of Therapy (2-4 Days Post Therapy)

    The "by pathogen" microbiological outcome was determined by comparing the baseline culture results to those at follow-up. The results presented below pooled all baseline pathogens (bps). Eradication: elimination of bps. Presumed Eradication: clinical outcome was success; no culture was obtained due to lack of culturable material. Presumed Improvement: clinical outcome was improvement such that no culture was obtained due to lack of culturable material. Persistence: bps still present. Presumed persistence: clinical failure and no culture was obtained.

    Measured: Days 7-9

  5. Number of Participants With Therapeutic Success and Failure at Follow-up (7-9 Days Post Therapy)

    "Therapeutic Success (Succ)" was referred to as both "Clinical Succ" and "Microbiological (Micro) Succ" at Follow-up. "Clinical Succ" was the "Resolution of baseline signs/symptoms of infection with a pus score of "0." A participant was "Micro Succ" if the micro outcome for all baseline pathogens (bps) belonged to "Eradication" (elimination of bps), "Presumed Eradication" (clinical outcome is success; no culturable material), or "Colonization" (new pathogen is identified at end of therapy in participants who are resolved/improved). All other combinations were deemed "Therapeutic Failures."

    Measured: Follow-up (Days 12-14)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionOct 2009
  4. Study completionOct 2009

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
508 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00684177
Sponsor's protocol ID
TOC110977
Status last verified
Oct 2016
First submitted
22 May 2008
Last updated
23 Nov 2016
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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Retapamulin Ointment, 1% in people with Skin Infections, Bacterial, run by GlaxoSmithKline at 54 sites in 5 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 6 inclusion and 13 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 23 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States, South Africa, India, Argentina, Brazil. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 4 Aug 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 Clinical Success and Failure at Follow-up (7-9 Days Post Therapy) for the Primary Efficacy Population (time frame: Days 12-14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00684177.

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 23 Nov 2016.

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