- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04287777
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
Intervention / Treatment
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
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Madrid, Spain, 28007
- Hospital Gregorio Marañón
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Madrid, Spain, 28003
- CAP Cea Bermúdez
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Madrid, Spain, 28018
- CAP Campo de la Paloma
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Madrid, Spain, 28023
- CAP Aravaca
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Madrid, Spain, 28026
- CAP La Calesas
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Andalucia
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Sevilla, Andalucia, Spain, 41016
- CAP Torreblanca
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Sevilla, Andalucia, Spain, 41980
- CAP La Algaba
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Catalonia
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Barcelona, Catalonia, Spain, 08023
- CAP Vallcarca-St. Gervasi
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Corbera De Llobregat, Catalonia, Spain, 08757
- CAP Corbera de Llobregat
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L'HOspitalet de Llobregat, Catalonia, Spain, 08905
- CAP Florida Nord
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L'Hospitalet De Llobregat, Catalonia, Spain, 08902
- CAP Amadeu Torner
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L'Hospitalet de Llobregat, Catalonia, Spain, 08902
- CAP Mossèn Cinto Verdager
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Lleida, Catalonia, Spain, 25007
- CAP Rambla Ferran
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Viladecans, Catalonia, Spain, 08840
- CAP Maria Bernades
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Madrid
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Arganda del Rey, Madrid, Spain, 28500
- H.U. Sureste
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Fuenlabrada, Madrid, Spain, 21942
- H.U. Fuenlabrada
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Fuenlabrada, Madrid, Spain, 28945
- CAP Castilla la Nueva
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Pinto, Madrid, Spain, 28320
- CAP Pinto
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Pozuelo de Alarcón, Madrid, Spain, 28224
- CAP Pozuelo de Alarcón
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San Sebastián de los Reyes, Madrid, Spain, 28702
- H.U. Infanta Sofía
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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 |
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Experimental: Mupirocin gel
Topical administration of Mupirocin gel 20 mg/g BID for 7 days
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Topical administration of Mupirocin gel 20 mg/g BID for 7 days
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Active Comparator: Mupirocin ointment
Topical administration of Mupirocin ointment 20mg/g TID for 7 days.
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Topical treatment of Mupirocin ointment 20 mg/g TID for 7 days
Other Names:
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Placebo Comparator: Placebo
Topical administration of Placebo (ointment) TID for 7 days
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Topical administration of Placebo (ointment) TID during 7 days
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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
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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).
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Day 8
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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
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proportion of subjects with no additional antibiotic therapy required to treat impetigo
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Day 8
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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
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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).
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Day14
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Clinical cure as assessed by the proportion of subjects with no additional antibiotic therapy required to treat impetigo at day 14
Time Frame: Day14
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proportion of subjects with no additional antibiotic therapy required to treat impetigo
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Day14
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Total SIRS score at the end of treatment and follow-up by blind observer
Time Frame: Day 8 and 14
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Day 8 and 14
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Bacteriology cure at follow-up
Time Frame: Day 14
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Bacteriology eradication at the end of follow-up period according to culture at screening and follow up visits
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Day 14
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Clinical cure at the end of treatment and follow-up by investigator
Time Frame: Day 8 and 14
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Proportion of subjects with clinical cure at the Day 8 and Day 14 visits, assessed by investigator, according to protocol criteria.
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Day 8 and 14
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SIRS total score at the end of treatment and follow-up by investigator
Time Frame: Day 8 and 14
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SIRS total Score at Day 8 and Day 14 visits, assessed by the investigator
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Day 8 and 14
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Streptococcal Infections
- Gram-Positive Bacterial Infections
- Skin Diseases, Infectious
- Staphylococcal Infections
- Skin Diseases, Bacterial
- Staphylococcal Skin Infections
- Impetigo
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Protein Synthesis Inhibitors
- Mupirocin
Other Study ID 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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Gundersen Lutheran Medical FoundationGundersen Lutheran Health SystemCompletedSurgical Site InfectionsUnited States
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-
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University of ChicagoCompletedEndophthalmitis | Prophylaxis | Cataract SurgeryUnited States
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-
B. Braun Medical SATerminatedMRSA - Methicillin Resistant Staphylococcus Aureus Infection | MRSA ColonizationSpain