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Safety and Efficacy of Mupirocin Gel in Children With Impetigo

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ClinicalTrials.gov Identifier: NCT04287777
Recruitment Status : Completed
First Posted : February 27, 2020
Last Update Posted : March 12, 2021
Sponsor:
Information provided by (Responsible Party):
Reig Jofre Group

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.

Condition or disease Intervention/treatment Phase
Impetigo Drug: Mupirocin gel Drug: Mupirocin ointment Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 467 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2014
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Impetigo

Arm Intervention/treatment
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 Name: Bactroban

Placebo Comparator: Placebo
Topical administration of Placebo (ointment) TID for 7 days
Drug: Placebo
Topical administration of Placebo (ointment) TID during 7 days




Primary Outcome Measures :
  1. 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).

  2. 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


Secondary Outcome Measures :
  1. 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).

  2. 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

  3. Total SIRS score at the end of treatment and follow-up by blind observer [ Time Frame: Day 8 and 14 ]
  4. 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

  5. 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.

  6. 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



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Ages Eligible for Study:   18 Months to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04287777


Locations
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Sponsors and Collaborators
Reig Jofre Group
Investigators
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Study Director: Raúl De Lucas, Dr. Hospital La Paz
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Responsible Party: Reig Jofre Group
ClinicalTrials.gov Identifier: NCT04287777    
Other Study ID Numbers: RJ-NBC01
First Posted: February 27, 2020    Key Record Dates
Last Update Posted: March 12, 2021
Last Verified: March 2021
Keywords provided by Reig Jofre Group:
Impetigo
Mupirocin
Mupirocin gel
Mupirocin ointment
Impetigo in children
Additional relevant MeSH terms:
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Impetigo
Staphylococcal Skin Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Streptococcal Infections
Skin Diseases, Bacterial
Skin Diseases, Infectious
Skin Diseases
Mupirocin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action