Safety and Efficacy of Mupirocin Gel in Children With Impetigo
Primary Purpose
Impetigo
Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Mupirocin gel
Mupirocin ointment
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Impetigo focused on measuring Impetigo, Mupirocin, Mupirocin gel, Mupirocin ointment, Impetigo in children
Eligibility Criteria
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.
Sites / Locations
- CAP Torreblanca
- CAP La Algaba
- CAP Vallcarca-St. Gervasi
- CAP Corbera de Llobregat
- CAP Amadeu Torner
- CAP Mossèn Cinto Verdager
- CAP Florida Nord
- CAP Rambla Ferran
- CAP Maria Bernades
- H.U. Sureste
- H.U. Fuenlabrada
- CAP Castilla la Nueva
- CAP Pinto
- CAP Pozuelo de Alarcón
- H.U. Infanta Sofía
- CAP Cea Bermúdez
- Hospital Gregorio MArañón
- CAP Campo de la Paloma
- CAP Aravaca
- CAP La Calesas
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Mupirocin gel
Mupirocin ointment
Placebo
Arm Description
Topical administration of Mupirocin gel 20 mg/g BID for 7 days
Topical administration of Mupirocin ointment 20mg/g TID for 7 days.
Topical administration of Placebo (ointment) TID for 7 days
Outcomes
Primary Outcome Measures
Clinical cure at the end of treatment by SIRS assessed by blind observer
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).
Clinical cure as assessed by the proportion of subjects with no additional antibiotic therapy required to treat impetigo at day 8
proportion of subjects with no additional antibiotic therapy required to treat impetigo
Secondary Outcome Measures
Clinical cure at the end of follow up by SIRS assessed by blind observer
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).
Clinical cure as assessed by the proportion of subjects with no additional antibiotic therapy required to treat impetigo at day 14
proportion of subjects with no additional antibiotic therapy required to treat impetigo
Total SIRS score at the end of treatment and follow-up by blind observer
Bacteriology cure at follow-up
Bacteriology eradication at the end of follow-up period according to culture at screening and follow up visits
Clinical cure at the end of treatment and follow-up by investigator
Proportion of subjects with clinical cure at the Day 8 and Day 14 visits, assessed by investigator, according to protocol criteria.
SIRS total score at the end of treatment and follow-up by investigator
SIRS total Score at Day 8 and Day 14 visits, assessed by the investigator
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04287777
Brief Title
Safety and Efficacy of Mupirocin Gel in Children With Impetigo
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reig Jofre Group
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impetigo
Keywords
Impetigo, Mupirocin, Mupirocin gel, Mupirocin ointment, Impetigo in children
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
467 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mupirocin gel
Arm Type
Experimental
Arm Description
Topical administration of Mupirocin gel 20 mg/g BID for 7 days
Arm Title
Mupirocin ointment
Arm Type
Active Comparator
Arm Description
Topical administration of Mupirocin ointment 20mg/g TID for 7 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Topical administration of Placebo (ointment) TID for 7 days
Intervention Type
Drug
Intervention Name(s)
Mupirocin gel
Intervention Description
Topical administration of Mupirocin gel 20 mg/g BID for 7 days
Intervention Type
Drug
Intervention Name(s)
Mupirocin ointment
Other Intervention Name(s)
Bactroban
Intervention Description
Topical treatment of Mupirocin ointment 20 mg/g TID for 7 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Topical administration of Placebo (ointment) TID during 7 days
Primary Outcome Measure Information:
Title
Clinical cure at the end of treatment by SIRS assessed by blind observer
Description
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).
Time Frame
Day 8
Title
Clinical cure as assessed by the proportion of subjects with no additional antibiotic therapy required to treat impetigo at day 8
Description
proportion of subjects with no additional antibiotic therapy required to treat impetigo
Time Frame
Day 8
Secondary Outcome Measure Information:
Title
Clinical cure at the end of follow up by SIRS assessed by blind observer
Description
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).
Time Frame
Day14
Title
Clinical cure as assessed by the proportion of subjects with no additional antibiotic therapy required to treat impetigo at day 14
Description
proportion of subjects with no additional antibiotic therapy required to treat impetigo
Time Frame
Day14
Title
Total SIRS score at the end of treatment and follow-up by blind observer
Time Frame
Day 8 and 14
Title
Bacteriology cure at follow-up
Description
Bacteriology eradication at the end of follow-up period according to culture at screening and follow up visits
Time Frame
Day 14
Title
Clinical cure at the end of treatment and follow-up by investigator
Description
Proportion of subjects with clinical cure at the Day 8 and Day 14 visits, assessed by investigator, according to protocol criteria.
Time Frame
Day 8 and 14
Title
SIRS total score at the end of treatment and follow-up by investigator
Description
SIRS total Score at Day 8 and Day 14 visits, assessed by the investigator
Time Frame
Day 8 and 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raúl De Lucas, Dr.
Organizational Affiliation
Hospital La Paz
Official's Role
Study Director
Facility Information:
Facility Name
CAP Torreblanca
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41016
Country
Spain
Facility Name
CAP La Algaba
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41980
Country
Spain
Facility Name
CAP Vallcarca-St. Gervasi
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08023
Country
Spain
Facility Name
CAP Corbera de Llobregat
City
Corbera De Llobregat
State/Province
Catalonia
ZIP/Postal Code
08757
Country
Spain
Facility Name
CAP Amadeu Torner
City
L'Hospitalet De Llobregat
State/Province
Catalonia
ZIP/Postal Code
08902
Country
Spain
Facility Name
CAP Mossèn Cinto Verdager
City
L'Hospitalet de Llobregat
State/Province
Catalonia
ZIP/Postal Code
08902
Country
Spain
Facility Name
CAP Florida Nord
City
L'HOspitalet de Llobregat
State/Province
Catalonia
ZIP/Postal Code
08905
Country
Spain
Facility Name
CAP Rambla Ferran
City
Lleida
State/Province
Catalonia
ZIP/Postal Code
25007
Country
Spain
Facility Name
CAP Maria Bernades
City
Viladecans
State/Province
Catalonia
ZIP/Postal Code
08840
Country
Spain
Facility Name
H.U. Sureste
City
Arganda del Rey
State/Province
Madrid
ZIP/Postal Code
28500
Country
Spain
Facility Name
H.U. Fuenlabrada
City
Fuenlabrada
State/Province
Madrid
ZIP/Postal Code
21942
Country
Spain
Facility Name
CAP Castilla la Nueva
City
Fuenlabrada
State/Province
Madrid
ZIP/Postal Code
28945
Country
Spain
Facility Name
CAP Pinto
City
Pinto
State/Province
Madrid
ZIP/Postal Code
28320
Country
Spain
Facility Name
CAP Pozuelo de Alarcón
City
Pozuelo de Alarcón
State/Province
Madrid
ZIP/Postal Code
28224
Country
Spain
Facility Name
H.U. Infanta Sofía
City
San Sebastián de los Reyes
State/Province
Madrid
ZIP/Postal Code
28702
Country
Spain
Facility Name
CAP Cea Bermúdez
City
Madrid
ZIP/Postal Code
28003
Country
Spain
Facility Name
Hospital Gregorio MArañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
CAP Campo de la Paloma
City
Madrid
ZIP/Postal Code
28018
Country
Spain
Facility Name
CAP Aravaca
City
Madrid
ZIP/Postal Code
28023
Country
Spain
Facility Name
CAP La Calesas
City
Madrid
ZIP/Postal Code
28026
Country
Spain
12. IPD Sharing Statement
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Safety and Efficacy of Mupirocin Gel in Children With Impetigo
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