Safety and Efficacy of Mupirocin Gel in Children With Impetigo

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

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.

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Spain

CAP Torreblanca

Sevilla, Andalucia, Spain, 41016

CAP La Algaba

Sevilla, Andalucia, Spain, 41980

CAP Vallcarca-St. Gervasi

Barcelona, Catalonia, Spain, 08023

CAP Corbera de Llobregat

Corbera De Llobregat, Catalonia, Spain, 08757

CAP Amadeu Torner

L'Hospitalet De Llobregat, Catalonia, Spain, 08902

CAP Mossèn Cinto Verdager

L'Hospitalet de Llobregat, Catalonia, Spain, 08902

CAP Florida Nord

L'HOspitalet de Llobregat, Catalonia, Spain, 08905

CAP Rambla Ferran

Lleida, Catalonia, Spain, 25007

CAP Maria Bernades

Viladecans, Catalonia, Spain, 08840

H.U. Sureste

Arganda del Rey, Madrid, Spain, 28500

H.U. Fuenlabrada

Fuenlabrada, Madrid, Spain, 21942

CAP Castilla la Nueva

Fuenlabrada, Madrid, Spain, 28945

CAP Pinto

Pinto, Madrid, Spain, 28320

CAP Pozuelo de Alarcón

Pozuelo de Alarcón, Madrid, Spain, 28224

H.U. Infanta Sofía

San Sebastián de los Reyes, Madrid, Spain, 28702

CAP Cea Bermúdez

Madrid, Spain, 28003

Hospital Gregorio MArañón

Madrid, Spain, 28007

CAP Campo de la Paloma

Madrid, Spain, 28018

CAP Aravaca

Madrid, Spain, 28023

CAP La Calesas

Madrid, Spain, 28026

Sponsors and Collaborators

Reig Jofre Group

Investigators

• Study Director: Raúl De Lucas, Dr.; Hospital La Paz

More Information

• Responsible Party: Reig Jofre Group
• ClinicalTrials.gov Identifier: NCT04287777
• Other Study ID Numbers: RJ-NBC01
• First Posted: February 27, 2020
• 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:

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