Safety and Efficacy of Mupirocin Gel in Children With Impetigo

Impetigo Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04287777
• Other study ID #: RJ-NBC01
• Status: Completed
• Phase: Phase 3
• Start date: February 2014
• Est. completion date: November 2016

Study information

• Verified date: March 2021
• Source: Reig Jofre Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 467
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Impetigo

Intervention

Drug:
• Mupirocin gel
Topical administration of Mupirocin gel 20 mg/g BID for 7 days
• Mupirocin ointment
Topical treatment of Mupirocin ointment 20 mg/g TID for 7 days
• Placebo
Topical administration of Placebo (ointment) TID during 7 days

Locations

Country	Name	City	State
Spain	H.U. Sureste	Arganda del Rey	Madrid
Spain	CAP Vallcarca-St. Gervasi	Barcelona	Catalonia
Spain	CAP Corbera de Llobregat	Corbera De Llobregat	Catalonia
Spain	CAP Castilla la Nueva	Fuenlabrada	Madrid
Spain	H.U. Fuenlabrada	Fuenlabrada	Madrid
Spain	CAP Amadeu Torner	L'Hospitalet De Llobregat	Catalonia
Spain	CAP Florida Nord	L'HOspitalet de Llobregat	Catalonia
Spain	CAP Mossèn Cinto Verdager	L'Hospitalet de Llobregat	Catalonia
Spain	CAP Rambla Ferran	Lleida	Catalonia
Spain	CAP Aravaca	Madrid
Spain	CAP Campo de la Paloma	Madrid
Spain	CAP Cea Bermúdez	Madrid
Spain	CAP La Calesas	Madrid
Spain	Hospital Gregorio MArañón	Madrid
Spain	CAP Pinto	Pinto	Madrid
Spain	CAP Pozuelo de Alarcón	Pozuelo de Alarcón	Madrid
Spain	H.U. Infanta Sofía	San Sebastián de los Reyes	Madrid
Spain	CAP La Algaba	Sevilla	Andalucia
Spain	CAP Torreblanca	Sevilla	Andalucia
Spain	CAP Maria Bernades	Viladecans	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Reig Jofre Group

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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).	Day14
Secondary	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	Day14
Secondary	Total SIRS score at the end of treatment and follow-up by blind observer		Day 8 and 14
Secondary	Bacteriology cure at follow-up	Bacteriology eradication at the end of follow-up period according to culture at screening and follow up visits	Day 14
Secondary	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.	Day 8 and 14
Secondary	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	Day 8 and 14