NCT04287777

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
467

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2014

Typical duration for phase_3

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
3.3 years until next milestone

First Posted

Study publicly available on registry

February 27, 2020

Completed
Last Updated

March 12, 2021

Status Verified

March 1, 2021

Enrollment Period

2.8 years

First QC Date

October 29, 2015

Last Update Submit

March 9, 2021

Conditions

Impetigo

Keywords

ImpetigoMupirocinMupirocin gelMupirocin ointmentImpetigo in children

Outcome Measures

Primary Outcomes (2)

  • 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).

    Day 8

  • 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

    Day 8

Secondary Outcomes (6)

  • Clinical cure at the end of follow up by SIRS assessed by blind observer

    Day14

  • Clinical cure as assessed by the proportion of subjects with no additional antibiotic therapy required to treat impetigo at day 14

    Day14

  • Total SIRS score at the end of treatment and follow-up by blind observer

    Day 8 and 14

  • Bacteriology cure at follow-up

    Day 14

  • Clinical cure at the end of treatment and follow-up by investigator

    Day 8 and 14

  • +1 more secondary outcomes

Study Arms (3)

Mupirocin gel

EXPERIMENTAL

Topical administration of Mupirocin gel 20 mg/g BID for 7 days

Drug: Mupirocin gel

Mupirocin ointment

ACTIVE COMPARATOR

Topical administration of Mupirocin ointment 20mg/g TID for 7 days.

Drug: Mupirocin ointment

Placebo

PLACEBO COMPARATOR

Topical administration of Placebo (ointment) TID for 7 days

Drug: Placebo

Interventions

Mupirocin gelDRUG

Topical administration of Mupirocin gel 20 mg/g BID for 7 days

Mupirocin gel
Mupirocin ointmentDRUG

Topical treatment of Mupirocin ointment 20 mg/g TID for 7 days

Also known as: Bactroban
Mupirocin ointment
PlaceboDRUG

Topical administration of Placebo (ointment) TID during 7 days

Placebo

Eligibility Criteria

Age18 Months - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

CAP Torreblanca

Seville, Andalusia, 41016, Spain

Location

CAP La Algaba

Seville, Andalusia, 41980, Spain

Location

CAP Vallcarca-St. Gervasi

Barcelona, Catalonia, 08023, Spain

Location

CAP Corbera de Llobregat

Corbera de Llobregat, Catalonia, 08757, Spain

Location

CAP Amadeu Torner

L'Hospitalet de Llobregat, Catalonia, 08902, Spain

Location

CAP Mossèn Cinto Verdager

L'Hospitalet de Llobregat, Catalonia, 08902, Spain

Location

CAP Florida Nord

L'Hospitalet de Llobregat, Catalonia, 08905, Spain

Location

CAP Rambla Ferran

Lleida, Catalonia, 25007, Spain

Location

CAP Maria Bernades

Viladecans, Catalonia, 08840, Spain

Location

H.U. Sureste

Arganda, Madrid, 28500, Spain

Location

H.U. Fuenlabrada

Fuenlabrada, Madrid, 21942, Spain

Location

CAP Castilla la Nueva

Fuenlabrada, Madrid, 28945, Spain

Location

CAP Pinto

Pinto, Madrid, 28320, Spain

Location

CAP Pozuelo de Alarcón

Pozuelo de Alarcón, Madrid, 28224, Spain

Location

H.U. Infanta Sofía

San Sebastián de los Reyes, Madrid, 28702, Spain

Location

CAP Cea Bermúdez

Madrid, 28003, Spain

Location

Hospital Gregorio MArañón

Madrid, 28007, Spain

Location

CAP Campo de la Paloma

Madrid, 28018, Spain

Location

CAP Aravaca

Madrid, 28023, Spain

Location

CAP La Calesas

Madrid, 28026, Spain

Location

MeSH Terms

Conditions

Impetigo

Interventions

Mupirocin

Condition Hierarchy (Ancestors)

Staphylococcal Skin InfectionsStaphylococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsStreptococcal InfectionsSkin Diseases, BacterialSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Epoxy CompoundsEthers, CyclicEthersOrganic ChemicalsPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFatty AcidsLipids

Study Officials

  • Raúl De Lucas, Dr.

    Hospital La Paz

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2015

First Posted

February 27, 2020

Study Start

February 1, 2014

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

March 12, 2021

Record last verified: 2021-03

Locations

ES(20)