single dose azithromycin versus multiple daily dose azithromycin in skin infectio

Phase 4

Completed

• Conditions: Health Condition 1: null- Patients with uncomplicated skin and skin structure infection

• Registration Number: CTRI/2015/07/005969
• Lead Sponsor: Institute of Postgraduate Medical Education Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 294

Inclusion Criteria

ï?§Subjects of either sex aged at least 12 years.

ï?§Clinically defined cases of uncomplicated skin and skin structure infection like folliculitis, impetigo, ecthyma, erysipelas, minor abscesses or cellulitis.

ï?§Able to complete informed consent process or, if minor, availability of a legally acceptable representative who would be able to complete this process. Subjects between 12-18 years of age would need to assent to the process.

ï?§Willing to complete the study protocol, study related activities, and visits.

ï?§Able to take oral antibiotic therapy, either in pill or suspension form.

Exclusion Criteria

ï?§Hospital in-patients or history of hospitalization within last 14 days.

ï?§Pregnancy or breast-feeding.

ï?§Complicated skin and soft tissue infection, such as catheter or catheter site infection within 30 days of placement, surgical site infection, known or suspected prosthetic site infection, unusual exposure history (e.g. underwater injury, fish-tank exposure, heavy soil exposure etc.

ï?§infection at the site of an area of underlying skin disease such as chronic eczema, psoriasis, atopic dermatitis, or chronic venous stasis

ï?§Diagnosed or suspected disseminated or severe staphylococcal or Group A streptococcal infection including lymphangitic spread of skin infection, septicemia, bacteremia, pneumonia, endocarditis, osteomyelitis, septic arthritis, gangrene, necrotizing fasciitis, myositis, or other serious infection.

ï?§Infection at an anatomical site requiring specialized management or specialized antimicrobial therapy including periauricular or orbital infection, perirectal infection, suspected deep space infection of the hand or foot, bursitis or mastitis.

ï?§Significant systemic signs such as fever > 101 ï?°F.

ï?§Systemic antibacterial therapy within last 14 days.

ï?§The following concomitant medications: warfarin, phenytoin, methotrexate, or sulfonylureas and systemically administered antibacterial agents with antistaphylococcal activity.

ï?§Any serious disorder of vital organs like liver, kidney, heart, lungs or bone marrow.

ï?§History of underlying immunocompromising condition or immunodeficiency.

ï?§History of allergy to azithromycin.

ï?§History of alcohol or substance abuse.

ï?§Participation in another clinical trial within last 30 days.

ï?§Any other condition, which, in the opinion of the investigator, would render the subject unsuitable for participation in the trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical cure characterized by complete resolution of all the signs and symptoms on day eight of either the first dose or supervised doseTimepoint: After one week from the base line visit

Secondary Outcome Measures

Name	Time	Method
suspected adverse drug reaction and treatment failure <br/ ><br>Timepoint: on day four and at the end of the study (day eight)