A randomised controlled trial of oral antibiotics compared with intravenous antibiotics for the treatment of cellulitis.

Phase 4

Completed

• Conditions: Cellulitis; Studies of infection and infectious agents; Skin - Other skin conditions; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12611000685910
• Lead Sponsor: orthern Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Referral from Emergency Department Staff for treatment of cellulitis with intravenous antibiotics as an inpatient or outpatient.

Exclusion Criteria

a)Necrotising fasciitis is suspected (suggested by involvement of subcutaneous tissues with subcutaneous induration, severe necrosis or gas, severe pain, rapid progression, severe sepsis, ongoing rigors, perineal or abdominal location)
b)Complicated cellulitis (hypotension or other signs of severe sepsis, bullous skin changes, abscess formation).
c)Cellulitis complicating trauma, especially penetrating injury (may need surgical debridement).
d)Site: periorbital cellulitis, perineal cellulitis.
e)Patient: Children (age < 16 years), Immunosuppressed patients
f)Vomiting or any other reason precluding oral antibiotic therapy.
g)Treatment with oral antibiotics for greater than 48 prior to referral or with intravenous antibiotics for greater than 12 hours before referral.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ack of progression of Erythema; measured as the maximum diameter of erythema in cms.[Day 1,2, 3, 7 and 28];The primary outcome measure was days until no advancement of the area of cellulitis. [Days until no advancement in cellulitis (measured daily until advancement ceased)]

Secondary Outcome Measures

Name	Time	Method
Rate of Complications from Cellulitis or Treatments.<br><br>Failure to respond to treatment, progression of erythema and /or development of signs and symptoms of systemic infection.<br>Requirement for escalation of treatment.<br>Requirement for readmission for management of cellulitis.[Day 3, 7 and 28 after commencement of treatment]