CompletedPhase 4ACTRN12611000685910

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


Sponsor

Northern Health

Enrollment

56 participants

Start Date

Mar 19, 2011

Study Type

Interventional

Conditions

Summary

Cellulitis is an acute spreading infection of the skin. It develops as a result of entry of bacteria, especially beta-haemolytic Streptococci spp. and Staphylococcus aureus, through the skin barrier. It is a common condition that is often thought by health professionals to require treatment with intravenous antibiotics initially, resulting a high rate of presentation and admission to acute medical services. To reduce the burden on hospital inpatient beds, intravenous antibiotics have increasingly been administered at home by visiting nursing services or Hospital In The Home (HITH) programs to treat cellulitis. Intravenous antibiotics have the associated problems of local intravenous line site complications including phlebitis and infection as well as the costs of nursing and medical staff required to administer the antibiotics. With these problems in mind, clinicians at the The Northern Hospital (TNH) have developed clinical experience successfully using oral antibiotics for many patients with cellulitis referred for treatment with intravenous antibiotics. Limited evidence exists supporting this approach in patients with cellulitis. Oral penicillin has been shown to be equivalent to initial intravenous then oral penicillin in inpatients admitted with the diagnosis of cellulitis. Similarly oral pristinomycin has been shown to be non-inferior to an intravenous then oral penicillin regimen for inpatients with cellulitis. Neither of these studies investigated patients treated by HITH programs nor did they use antibiotics regimens that would commonly be prescribed in Australia for this indication. There is more recent and substantial evidence showing success in favouring early oral antibiotics in patients with community-acquired pneumonia another common infection that was previously thought to require intravenous antibiotics in many cases presenting to hospital. Justification for project Any research that demonstrated that treatment of cellulitis with oral antibiotics was as effective as treatment with intravenous antibiotics would have important implications in that patients may be able to be treated more safely and with less expense. Comparison with patients treated in HITH settings and in Australia with antibiotics commonly used here would have particular relevance. If information gained from this trial is useful then this may be used to justify a larger multi-centre trial to more definitively inform guidelines in the area.


Eligibility

Sex: Both males and femalesMin Age: 16 YearssMax Age: 100 Yearss

Plain Language Summary

Simplified for easier understanding

This trial compares oral antibiotics versus intravenous antibiotics for treating cellulitis (a common skin infection) in adults aged 16 and older. If oral treatment proves equally effective, it could spare many patients from hospital stays or outpatient IV therapy.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

intervention(s) / exposure* Intravenous Antibiotics Cefazolin 2g intravenously 12 hourly or if immediate penicillin hypersensitivity exists, Clindamycin 450mg iv eight hourly. 2-3 days of Intrave

intervention(s) / exposure* Intravenous Antibiotics Cefazolin 2g intravenously 12 hourly or if immediate penicillin hypersensitivity exists, Clindamycin 450mg iv eight hourly. 2-3 days of Intravenous antibiotics or until progression of erythema stops then followed by oral for total treatment duration of 10 days. Oral Treatment: Cephalexin 1g orally every six hours or if immediate penicillin hypersensitivity exists, Clindamycin 450mg every eight hours to complete a total of 10 days of antibiotic treatment..


Locations(1)

Australia

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