The comparative study of Nadifloxacin and Mupirocin in children with skin and soft tissue infectio

Phase 4

Completed

• Conditions: Health Condition 1: null- children with skin and soft tissue infection

• Registration Number: CTRI/2018/03/012411
• Lead Sponsor: Dr Swapnil Janbandhu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-02-27
• Last Update Posted: 2021-11-24

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1.Male or female patients <12 years of age.

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

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

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1.Median change from baseline in severity of individual clinical features of SSTI e.g. erythema, exudation, swelling, pruritus, crusting, pain and tenderness <br/ ><br>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.