Duration of ANtibiotic Therapy for CEllulitis (DANCE)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status and phase: Terminated; Phase 4

Conditions: Cellulitis; Erysipelas

Treatments: Drug: Placebo (for flucloxacillin); Drug: Flucloxacillin

Study type: Interventional

Funder types: Other

Identifiers

NCT02032654

836011024 (Other Grant/Funding Number)

2013-002106-31 (EudraCT Number)

4360

NL44512.018.13

Details and patient eligibility

About

Cellulitis is among the most common infections leading to hospitalization, yet the optimal duration of therapy remains ill defined. Pragmatically, Dutch guidelines advise 10-14 days of antibiotics, which is the current standard of care. Recently it has been shown that antibiotic treatment for pneumonia and urinary tract infections can safely and significantly be shortened. Importantly, in an outpatient setting, treatment of uncomplicated cellulitis with 5 days of antibiotics was as effective as 10 days. We hypothesize that there is no difference in outcomes when patients hospitalized with cellulitis are treated with either a short-course (6 days) or standard-course (12 days) of antibiotics.

Enrollment: 151 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Admitted to receive intravenous antibiotics for cellulitis/erysipelas
• 18 years of age or older
• Capable of giving written informed consent, able to comply with study requirements and restrictions

Exclusion criteria

• Allergy for flucloxacillin, other beta-lactam antibiotics or one of the additives, or flucloxacillin induced hepatitis or liver enzyme disorders.

• Concurrent use of antibiotics for other indications

• Alternative diagnosis accounting for the clinical presentation.

• All cases involving any of the following complicating factors:

  • Use of antibiotics with Gram-positive activity for more than 4 days in the past 7 days

  • Intensive care unit admission during the last 7 days

  • Severe peripheral arterial disease (Fontaine IV)

  • Severe cellulitis necessitating surgical debridement or fascial biopsy

  • Necrotizing fasciitis

  • Periorbital or perirectal involvement

  • Surgery

  • Life expectancy less than one month

  • Risk factors associated with Gram-negative pathogens as a causative agent:

    • Chronic or macerated infra-malleolar ulcers, or infra-malleolar ulcers with previous antibiotic treatment, in patients with diabetes mellitus.
    • Neutropenia
    • Cirrhosis (Child-Pugh class B or C)
    • Intravenous drug use
    • Human or animal bite
    • Skin laceration acquired in fresh or salt open water
    • Fish fin or bone injuries

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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151 participants in 2 patient groups

Standard course

Active Comparator group

Description:

Flucloxacillin (1000mg iv OR, later, 500mg capsules), every 6 hours, for 6 days, followed by: Flucloxacillin 500mg capsules, every 6 hours, for 6 days

Treatment:

Drug: Flucloxacillin

Short course

Experimental group

Description:

Flucloxacillin (1000mg iv OR, later, 500mg capsules), every 6 hours, for 6 days, followed by: Placebo (for flucloxacillin 500mg) 500mg capsules, every 6 hours, for 6 days

Treatment:

Drug: Placebo (for flucloxacillin)

Drug: Flucloxacillin