Is Oral or Intravenous administration of antibiotics superior in the treatment of moderate cellulitis?

Superiority of Oral or Intravenous administration of antibiotics in the treatment of moderate cellulitis, a randomised control trial.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618001840279

Enrollment

412

Registered

2018-11-12

Start date

2019-01-01

Completion date

2020-01-01

Last updated

2018-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Cellulitis, a spreading skin infection treated with antibitoics, is routinely stratified according to severity and patient risk factors. Moderate-severity cellulitis is commonly treated with short-course intravenous antibitoics followed by oral antibiotics. This is some evidence to suggest moderate-severity cellulitis could be safely treated with oral antibiotics. This prospective, single-blinded trial will assess the efficacy and safety of oral antibiotics for the treatment of moderate-severity cellulitis. Participants will be randomized to treatment with either oral or intravenous antibiotics and assessed for rates of treatment success and complications.

Interventions

Oral Antibiotics, 1g Flucloxacillin four times daily or 450mg Clindamycin three times daily in case of penicillin immediate type hypersensitivity. Therapies will be directly administered as inpatient treatment with administration recorded in medication charts.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

Presence of Cellulitis as defined by the presence of acute dermal/epidermal inflammation lasting <5 days and of probable infective aetiology. At least one marker of moderate severity, either a marker of systemic inflammatory response (documented temperature >37.8c, tachycardia >90bpm, systemic symptoms inc. malaise, flu like symptoms, nausea and vomiting or elevated inflammatory markers) or a risk factor eg. Diabetes, homelessness, etc.

Exclusion criteria

Patients will be excluded if they are unable to or decline consent; have mild cellulitis suitable for immediate discharge(limited area <10cm in longest axis, no risk factors, no systemic symptoms); cellulitis complicating trauma, intravenous drug use or recent (<30 days) surgical sites; periorbital cellulitis; immunosuppressed patients; morbidly obese patients; a diagnosis other than cellulitis or complicated cellulitis (severe sepsis, extensive bullous changes, abscess formation or suspected necrotising deep tissue involvement); vomiting precluding oral therapy or prior treatment with per protocol oral antimicrobials for >48 hours or parenteral antimicrobials

Outcome results