Clinical trial NCT02032654: Duration of ANtibiotic Therapy for CEllulitis
Official title: Duration of Antibiotic Therapy for Cellulitis (DANCE): a Randomized Controlled Trial Comparing 6 to 12 Days of Antibiotic Therapy for Patients Hospitalized With Cellulitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Cellulitis
Erysipelas
Keywords: antibiotics
flucloxacillin
therapy duration
cellulitis
erysipelas
skin infections
hospital
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2014-01-10
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Part 1/2: Resolution...
timeFrame: day 14
measure: Part 2/2: ...without relapse
timeFrame: day 28
Secondary outcomes:
measure: Resolution without relapse
timeFrame: day 28
measure: Recurrence at day 90
timeFrame: 90 days
measure: Objective speed of recovery
timeFrame: Up to 90 days
measure: Health related Quality of Life
timeFrame: Up to 90 days
measure: Health care resource utilisation
timeFrame: Up to 90 days
measure: Subjective speed of recovery
timeFrame: Up to 90 days
measure: Additional antibiotic usage
timeFrame: Up to 90 days
measure: Time to relapse
timeFrame: Up to 90 days
Other outcomes:
measure: Cellulitis severity score subgroup analysis
timeFrame: up to day 28
measure: Diabetes mellitus subgroup analysis
timeFrame: up to day 28
measure: Per protocol analysis
timeFrame: up to 28 days
measure: Per protocol analysis of the "resolution without relapse" secondary outcome
timeFrame: up to 28 days
measure: Sensitivity analyses of the "resolution without relapse" secondary outcome
timeFrame: up to 28 days
measure: Adjustments for baseline covariates
timeFrame: up to day 28
Locations:
city: Almere
country: Netherlands
facility: Flevoziekenhuis
state: Flevoland
city: Amsterdam
country: Netherlands
facility: Sint Lucas Andreas Ziekenhuis
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Slotervaartziekenhuis
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: VU university medical center
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Academic Medical Center - University of Amsterdam
state: Noord-Holland
city: Haarlem
country: Netherlands
facility: Spaarne Gasthuis Locatie Haarlem Zuid
state: Noord-Holland
city: Hilversum
country: Netherlands
facility: Tergooi
state: Noord-Holland
city: Utrecht
country: Netherlands
facility: St. Antonius Ziekenhuis locatie Utrecht
city: Utrecht
country: Netherlands
facility: Diakonessenhuis
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: W. Joost Wiersinga, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Jan M. Prins, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cranendonk DR, Hugenholtz F, Prins JM, Savelkoul PHM, Budding AE, Wiersinga WJ; DANCE Consortium. The Skin Microbiota in Patients Hospitalized for Cellulitis and Association With Outcome. Clin Infect Dis. 2019 Apr 8;68(8):1292-1299. doi: 10.1093/cid/ciy709.
citation: Cranendonk DR, Opmeer BC, Prins JM, Wiersinga WJ. Comparing short to standard duration of antibiotic therapy for patients hospitalized with cellulitis (DANCE): study protocol for a randomized controlled trial. BMC Infect Dis. 2014 May 5;14:235. doi: 10.1186/1471-2334-14-235.