Impetigo
Conditions
Interventions
Product Name: InfectoMupi Salbe 2 %
Product Code: n.a.
Pharmaceutical Form: Ointment
INN or Proposed INN: Mupirocin
CAS Number: 12650-69-0
Current Sponsor code: n.a.
Other descriptive name: Pseudomoni
Sponsors
INFECTOPHARM Arzneimittel und Consilium GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: -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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Clinical cure at the final examination on Day 14;Secondary Objective: - Microbiological cure at the final examination on Day 14 - Clinical cure on Day 7 - Microbiological cure on Day 7 - Termination due to inefficacy on Day 3 - SIRS (Skin Infection Ratin Scale) on Day 7 and Day 14 - 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy -Microbiological cure at the final examination on Day 14 -Clinical cure on Day 7 -Microbiological cure on Day 7 -Termination due to inefficacy on day 3 -SIRS (Skin Infection Rating Scale) on Day 7 and Day 14 -Change in SIRS score from baseline to Day 7, from baseline to Day 14, and from Day 7 to Day 14 Tolerance -Adverse events by nature of the event, System Organ Class, severity, and causality -Serious adverse events by nature of the event, System Organ Class, and causality -Side effects -Dropouts ;Timepoint(s) of evaluation of this end point: Day 3 and/or Day 7 and/or Day 14 Tag 3 und/oder Tag 7 und/oder Tag 14 | — |
Countries
Germany
Contacts
Public ContactDr. Bertil Wachall
INFECTOPHARM Arzneimittel und Consilium GmbH
Outcome results
None listed