Safety and Efficacy of Mupirocin Gel in Children With Impetigo

March 9, 2021 updated by: Reig Jofre Group

Ph-III Randomized, Multicentric, Controlled , Non-inferiority Trial to Evaluate the Safety and Efficacy of Mupirocin Gel 20 mg/g Versus Mupirocin Ointment 20 mg/g and Placebo in the Treatment of Impetigo in Paediatric Population

The purpose of the study is to show non inferiority in terms of safety and efficacy of topical administration BID (Twice daily) of Mupirocin Gel 20 mg/g compared to topical administration of Mupirocin Ointment 20 mg/g TID (three times daily) (Bactroban) in the treatment of impetigo in paediatric population.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
467

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28007
        • Hospital Gregorio Marañón
      • Madrid, Spain, 28003
        • CAP Cea Bermúdez
      • Madrid, Spain, 28018
        • CAP Campo de la Paloma
      • Madrid, Spain, 28023
        • CAP Aravaca
      • Madrid, Spain, 28026
        • CAP La Calesas
    • Andalucia
      • Sevilla, Andalucia, Spain, 41016
        • CAP Torreblanca
      • Sevilla, Andalucia, Spain, 41980
        • CAP La Algaba
    • Catalonia
      • Barcelona, Catalonia, Spain, 08023
        • CAP Vallcarca-St. Gervasi
      • Corbera De Llobregat, Catalonia, Spain, 08757
        • CAP Corbera de Llobregat
      • L'HOspitalet de Llobregat, Catalonia, Spain, 08905
        • CAP Florida Nord
      • L'Hospitalet De Llobregat, Catalonia, Spain, 08902
        • CAP Amadeu Torner
      • L'Hospitalet de Llobregat, Catalonia, Spain, 08902
        • CAP Mossèn Cinto Verdager
      • Lleida, Catalonia, Spain, 25007
        • CAP Rambla Ferran
      • Viladecans, Catalonia, Spain, 08840
        • CAP Maria Bernades
    • Madrid
      • Arganda del Rey, Madrid, Spain, 28500
        • H.U. Sureste
      • Fuenlabrada, Madrid, Spain, 21942
        • H.U. Fuenlabrada
      • Fuenlabrada, Madrid, Spain, 28945
        • CAP Castilla la Nueva
      • Pinto, Madrid, Spain, 28320
        • CAP Pinto
      • Pozuelo de Alarcón, Madrid, Spain, 28224
        • CAP Pozuelo de Alarcón
      • San Sebastián de los Reyes, Madrid, Spain, 28702
        • H.U. Infanta Sofía

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 18 months and 15 years at the signature of informed consent
  • Impetigo susceptible to be treated with topical mupirocin and non requiring systemic antibiotic treatment (maximum of 4 different affected areas and no fever).
  • Global score of Skin Infection Rating Scale (SIRS) ≥ 4, with positive value (≥ 1) in at least 3 of the 5 categories evaluated.
  • Signature of informed consent by parent or legal tutor and, in case of mature minor (12 years or more), signature of informed assent.
  • Patient or parent's ability to understand and fulfill with protocol requirements.
  • In potentially pregnant patients, negative pregnancy urine test at baseline and use of reliable contraception double barrier methods during the trial.

Exclusion Criteria:

  • Allergy to any compound of the trial treatments
  • Have received systemic treatment with antibiotics or steroids, during the week prior to the baseline visit.
  • Have received topical treatment with corticosteroids, antibiotics or antifungals, during the 48 hours prior to the baseline visit.
  • Primary or secondary immunodeficiency.
  • Have received cytostatic or immunosuppressive treatment three months prior to baseline.
  • Any skin disorder that could interfere with the evaluation of the results of impetigo, such as presence of staphylococcal or streptococcal ecthyma, cellulitis, furunculosis, acute dermatitis, contact dermatitis or impetiginized eczema.
  • Diabetes mellitus.
  • Infection that, in the investigator's opinion, should be treated with systemic antibiotic.
  • Any medical condition which, in the investigator's opinion, contraindicates the subject's participation in the trial.
  • Forecast of little cooperation, non-compliance with medical treatment or low credibility.
  • Have participated in any clinical investigation with medicine within 30 days prior to basal visit.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mupirocin gel
Topical administration of Mupirocin gel 20 mg/g BID for 7 days
Drug: Mupirocin gel
Topical administration of Mupirocin gel 20 mg/g BID for 7 days
Active Comparator: Mupirocin ointment
Topical administration of Mupirocin ointment 20mg/g TID for 7 days.
Drug: Mupirocin ointment
Topical treatment of Mupirocin ointment 20 mg/g TID for 7 days
Other Names:
  • Bactroban
Placebo Comparator: Placebo
Topical administration of Placebo (ointment) TID for 7 days
Drug: Placebo
Topical administration of Placebo (ointment) TID during 7 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical cure at the end of treatment by SIRS assessed by blind observer
Time Frame: Day 8
Proportion of subjects with clinical cure at the Day 8 visit, assessed by blind observer, according to criteria described in the Protocol (SIRS < or = 2).
Day 8
Clinical cure as assessed by the proportion of subjects with no additional antibiotic therapy required to treat impetigo at day 8
Time Frame: Day 8
proportion of subjects with no additional antibiotic therapy required to treat impetigo
Day 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical cure at the end of follow up by SIRS assessed by blind observer
Time Frame: Day14
Proportion of subjects with clinical cure at the Day 14 visit, assessed by blind observer, according to criteria described in the protocol (SIRS < or = 2).
Day14
Clinical cure as assessed by the proportion of subjects with no additional antibiotic therapy required to treat impetigo at day 14
Time Frame: Day14
proportion of subjects with no additional antibiotic therapy required to treat impetigo
Day14
Total SIRS score at the end of treatment and follow-up by blind observer
Time Frame: Day 8 and 14
Day 8 and 14
Bacteriology cure at follow-up
Time Frame: Day 14
Bacteriology eradication at the end of follow-up period according to culture at screening and follow up visits
Day 14
Clinical cure at the end of treatment and follow-up by investigator
Time Frame: Day 8 and 14
Proportion of subjects with clinical cure at the Day 8 and Day 14 visits, assessed by investigator, according to protocol criteria.
Day 8 and 14
SIRS total score at the end of treatment and follow-up by investigator
Time Frame: Day 8 and 14
SIRS total Score at Day 8 and Day 14 visits, assessed by the investigator
Day 8 and 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Reig Jofre Group

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Raúl De Lucas, Dr., Hospital La Paz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RJ-NBC01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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