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

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

467

Phase

  • 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

      • 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

Ages Eligible for Study

2 months to 13 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
Intervention / Treatment
Experimental: Mupirocin gel
Topical administration of Mupirocin gel 20 mg/g BID for 7 days
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.
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
Topical administration of Placebo (ointment) TID during 7 days

What is the study measuring?

Primary Outcome Measures

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

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.

Investigators

  • 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

February 1, 2014

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

October 29, 2015

First Submitted That Met QC Criteria

February 25, 2020

First Posted (Actual)

February 27, 2020

Study Record Updates

Last Update Posted (Actual)

March 12, 2021

Last Update Submitted That Met QC Criteria

March 9, 2021

Last Verified

March 1, 2021

More Information

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.

Clinical Trials on Impetigo

Clinical Trials on Mupirocin gel

3
Subscribe