Multicenter, prospective, double-blind, two-armed phase III study for efficacy and safety of the topic impetigo therapy of two 2 % mupirocin ointments
- Conditions
- ImpetigoTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2011-002001-30-DE
- Lead Sponsor
- INFECTOPHARM Arzneimittel und Consilium GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
- Written informed consent of both parents/legal guardians
- Clinically diagnosed impetigo
- Skin Infection Rating Scale SIRS = 4
- = 3 SIRS categories existing
- Detection of staphylococcus aureus and/or streptococcus pyogenes in the initial swab from the affected spot
- 28 days up to 15 years of age
Are the trial subjects under 18? yes
Number of subjects for this age range: 120
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
-Necessity of a systemic therapy with antibiotics due to the severity and/or expansion of the impetigo or of a concomitant infection
- Extensively infected skin areas
-Affection of critical body regions as the auditory canal and the corner of the eye
-Impetigo as a secondary infection of a bite injury
- Impetigo in the area of central venous catheters
- Intranasally located impetigo
-Dermatological diseases that could impair the assessment of the impetigo (e. g. ecthyma, furunculosis, abscess, contact dermatitis, bite injuries)
-Clinically relevant primary or secondary immunodeficiency
-Current or less than 6 months dating back malign tumour diseases, chemotherapy, or radiotherapy
-Inadequately adjusted clinically relevant diabetes
- Known moderate or severe renal insufficiancy
-Other severe diseases that the investigator assesses as conflicting with the participation
-Systemic or dermal therapy with antibiotics, antimycotics, or corticoids during the past 7 days
-Dermal application of antiseptics during the past 7 days
-Girls of child-bearing potential
-Known intolerance to macrogol or mupirocin
- Inability of the parents to understand the instructions of the study
- Obvious unreliability of the parents or missing willingness to cooperate
- Known addiction of the parents to alcohol, medicaments, or drugs
- Limited legal competence of the parents or juricically/regulatorily ordered commitment to an institution
- Dependency of the child or the parents on the sponsor or on an investigator
- Participation in a clinical trial during the past 30 days
- Previous participation in the present clinical trial
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Clinical cure at the final examination on Day 14;Secondary Objective: - Microbiological cure at the final examination on Day 14<br>- Clinical cure on Day 7<br>- Microbiological cure on Day 7<br>- Termination due to inefficacy on Day 3<br>- SIRS (Skin Infection Ratin Scale) on Day 7 and Day 14<br>- Change in SIRS score from baseline on Day 7, from baseline to Day 14 and from Day 7 to Day 14;Primary end point(s): Clinical cure at the final examination on Day 14;Timepoint(s) of evaluation of this end point: Day 14/Tag 14
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Efficacy<br>-Microbiological cure at the final examination on Day 14<br>-Clinical cure on Day 7<br>-Microbiological cure on Day 7<br>-Termination due to inefficacy on day 3<br>-SIRS (Skin Infection Rating Scale) on Day 7 and Day 14<br>-Change in SIRS score from baseline to Day 7, from baseline to Day 14, and from Day 7 to Day 14<br><br>Tolerance<br>-Adverse events by nature of the event, System Organ Class, severity, and causality<br>-Serious adverse events by nature of the event, System Organ Class, and causality<br>-Side effects<br>-Dropouts<br>;Timepoint(s) of evaluation of this end point: Day 3 and/or Day 7 and/or Day 14<br>Tag 3 und/oder Tag 7 und/oder Tag 14