Health Condition 1: null- children with skin and soft tissue infection
Conditions
Interventions
Intervention1: Nadifloxacin 1% ointment: Parents of all patients in the study will receive Nadifloxacin ointment 1% as study treatment instructing them to apply it topically as a thin uniform film cov
Sponsors
Dr Swapnil Janbandhu
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients 2. Patients suffering from mild to moderate bacterial SSTI including the following but not limited to impetigo, secondarily infected wounds, folliculitis, infected atopic dermatitis or furunculosis 3. Accompanying parent willing and able to understand study requirements and provide written informed consent form on behalf of the child if child is less than equal to 5 years. In case of child older than 5 years, willingness and ability of child to provide assent as well as to communicate with the investigator for study purpose.
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity to quinolones or mupirocin. 2. Receipt of any topical treatment at the same site within 1 week prior to study entry. 3. Receipt of any systemic antimicrobials within 1 week prior to study entry. 4. Receipt of any investigational drug within 4 weeks prior to study entry. 5. Patients with presence of any concomitant disease or health problem that may interfere in study assessments or endanger patient safety during study treatment. 6. Any other significant illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigator will rate Clinical features of SSTI such as erythema, exudation, swelling, pruritus, crusting, pain and tenderness for their severity on the 4-point scalescale (0 â?? absent, 1 â?? mild, 2 â?? moderate and 3 â?? severe)Timepoint: Assessment is done on Visit 1(Day 1), Visit 2(Day 4), Visit 3(Day 8), Visit 4(Day 15) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Median change from baseline in severity of individual clinical features of SSTI e.g. erythema, exudation, swelling, pruritus, crusting, pain and tenderness 2. Bacteriological Cure: Bacterial culture will be done from the sample (Swab sample to be collected on both occasion) taken from SSTI site before starting the study treatment (visit 1) and at the end of study treatment (visit 4)Timepoint: Bacteriological Cure-Bacterial culture will be done from the sample (swab) taken from SSTI site before starting the study medication and at the visit 4. | — |
Countries
India
Contacts
Public ContactDr Swapnil Janbandhu
Lifepoint Multispecialty Hospital
Outcome results
None listed