Efficacy, Safety, and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)

Study Overview
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Brief Summary
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An international, multi-centre, prospective three arm parallel-group, phase II proof of concept study comparing the efficacy and safety of two dosage regimens (BID 7 days and TID 7 days) of TD1414 2% cream and one dosage regimen (BID 7 days) of Bactroban® (mupirocin) 2% cream in adults and children down to 2 years of age with impetigo or SITL. Furthermore an evaluation of the pharmacokinetics of TD1414 2% cream TID for 7 days will be performed. A total of 664 patients will be enrolled in a stepwise manner according to age groups starting with the oldest age group.

Official Title
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Efficacy, Safety and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)

Conditions
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Impetigo, Secondarily Infected Traumatic Lesions

Intervention / Treatment
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* Drug: TD1414 2% cream
* Drug: TD1414 2% cream
* Drug: Bactroban® (mupirocin) 2% cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed and dated informed consent from patient and/or legally acceptable representative has been obtained Outpatients of any sex or ethnic origin Patients >= 2 years of age (depending on study step) Patients must be suffering from primary bullous/non-bullous impetigo or SITL Exclusion Criteria: Presence of skin diseases at or near the investigational area Immunosuppressed state or other serious systemic disease Signs and/or symptoms of systemic infection Presence of skin infection/disorder not amenable to topical antibacterial treatment only Presence of secondarily-infected animal/human bite Presence of secondarily infected burnwound Topical or systemic use of medicinal or other products before or during the study which in the investigators opinion could confound the evaluation of the effect of the study drugs Known or suspected hypersensitivity to TD1414 or any of the excipients in the TD1414 2% cream Known or suspected hypersensitivity to mupirocin or any of the excipients in the Bactroban® (mupirocin) 2% cream Participation in any other investigational drug study or use of (an) investigational drug(s) within the 30 days or 5 half-lives (whichever is longer) prior to randomisation Patients previously enrolled/randomised in this study Abnormal ECG at baseline though the PR interval may be up to 220 ms, the QRS interval up to 110 ms and the QTc interval up to 450 ms

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: TD1414 2% cream<br>* BID 7 days<br>|
| Experimental: 2<br> | Drug: TD1414 2% cream<br>* TID 7 days<br>|
| Active Comparator: 3<br> | Drug: Bactroban® (mupirocin) 2% cream<br>* BID 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants With Clinical Cure According to Investigator's Assessment | At end of treatment (Day 8), the participants had their impetigo/Secondarily Infected Traumatic Lesions (SITL) evaluated by the (sub)investigator. Investigator's assessment of severity of infections (SIRS). Exudates/pus Crusting Erythema Oedema Tissue Warmth Itching Pain Each sign/symptoms of infection was assessed by use of the following 4-point scale: 0 = absent 2 = mild 4 = moderate 6 = severe The scores were summed up to a total SIRS score. Clinical cure was either of the following: Total absence of signs and symptoms of impetigo/SITL OR Improvement - total SIRS score reduced to <8 and all individual clinical signs/symptoms included in the SIRS score should have been ≤4. Clinical failure was either of the following: Signs and symptoms of impetigo/SITL that did not meet the definition of clinical cure Unable to determine (e.g. participants who refuse clinical examination or did not show at end of treatment or follow-up). | At end of treatment (Day 8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants With Clinical Cure According to Investigator's Assessment | At follow up (Day 15), the participants had their impetigo/SITL evaluated by the (sub)investigator. | At follow up (Day 15) | 
| Participants With Clinical Cure According to Investigator's Assessment. | At end of treatment (Day 8) and at follow-up (Day 15), the participants had their impetigo/SITL evaluated by the (sub)investigator. | At end of treatment (Day 8) and follow-up (Day 15) | 
| Participants With Bacteriological Cure According to Bacteriological Samples | At baseline (Day 1), end of treatment (EOT), and follow-up (FU), the investigator obtained a bacteriological sample to base the assessment on. Bacteriological cure was either of the following: Eradication of the baseline pathogen. Presumed eradication of the baseline pathogen Infection with a pathogen different from the baseline pathogen at EOT or FU and the participant was NOT symptomatic. Bacteriological failure was any of the following: Documented lack of eradication of the baseline pathogen. Documented relapse (re-infection) with the baseline pathogen Documented super-infection, i.e. infection with a pathogen different from the baseline pathogen at EOT or FU, and the participants was symptomatic Presumed persistence of baseline pathogen: Non-evaluable participants- participants who refused bacteriological examination or did not show at EOT or FU, and clinical failures who had no bacteriological sample to rule out bacterial infection. | At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up | 
| Participants With Clinical and Bacteriological Cure According to Investigator's Assessment and Bacteriological Samples | At end of treatment (Day 8) and at follow-up (Day 15) the participants had their impetigo/SITL evaluated by the (sub)investigator. At baseline (Day 1), end of treatment (Day 8) and at follow-up (Day 15) the investigator obtained a bacteriological sample on which an assessment of bacteriological cure was based. | At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up | 
| Participants With Clinical Cure According to Investigator's Assessment | At Day 4 the participants had their impetigo/SITL evaluated by the (sub)investigator. | At Day 4 |