Study Stopped
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Duration of ANtibiotic Therapy for CEllulitis
DANCE
Duration of Antibiotic Therapy for Cellulitis (DANCE): a Randomized Controlled Trial Comparing 6 to 12 Days of Antibiotic Therapy for Patients Hospitalized With Cellulitis
4 other identifiers
interventional
151
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Aug 2014
Typical duration for phase_4
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2014
CompletedFirst Posted
Study publicly available on registry
January 10, 2014
CompletedStudy Start
First participant enrolled
August 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 24, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 25, 2017
CompletedOctober 10, 2017
October 1, 2017
2.9 years
January 8, 2014
October 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Part 1/2: Resolution...
Resolution of cellulitis at day 14, defined as disappearance of warmth and tenderness at the site of infection, with substantial improvement in erythema and edema
day 14
Part 2/2: ...without relapse
No recurrence by day 28, defined as the need for additional antibiotic therapy for cellulitis
day 28
Secondary Outcomes (8)
Resolution without relapse
day 28
Recurrence at day 90
90 days
Objective speed of recovery
Up to 90 days
Health related Quality of Life
Up to 90 days
Health care resource utilisation
Up to 90 days
- +3 more secondary outcomes
Other Outcomes (6)
Cellulitis severity score subgroup analysis
up to day 28
Diabetes mellitus subgroup analysis
up to day 28
Per protocol analysis
up to 28 days
- +3 more other outcomes
Study Arms (2)
Standard course
ACTIVE COMPARATORFlucloxacillin (1000mg iv OR, later, 500mg capsules), every 6 hours, for 6 days, followed by: Flucloxacillin 500mg capsules, every 6 hours, for 6 days
Short course
EXPERIMENTALFlucloxacillin (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
Interventions
Sugar capsule manufactured to mimic flucloxacillin 500mg capsules
Eligibility Criteria
You may qualify if:
- Admitted to receive intravenous antibiotics for cellulitis/erysipelas
- years of age or older
- Capable of giving written informed consent, able to comply with study requirements and restrictions
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Flevoziekenhuis
Almere Stad, Flevoland, 1300EG, Netherlands
Sint Lucas Andreas Ziekenhuis
Amsterdam, North Holland, 1061AE, Netherlands
Slotervaartziekenhuis
Amsterdam, North Holland, 1066EC, Netherlands
VU university medical center
Amsterdam, North Holland, 1081HV, Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, North Holland, 1087CH, Netherlands
Academic Medical Center - University of Amsterdam
Amsterdam, North Holland, 1105AZ, Netherlands
Spaarne Gasthuis Locatie Haarlem Zuid
Haarlem, North Holland, 2035RC, Netherlands
Tergooi
Hilversum, North Holland, 1213XZ, Netherlands
St. Antonius Ziekenhuis locatie Utrecht
Utrecht, 3543AZ, Netherlands
Diakonessenhuis
Utrecht, 3582KE, Netherlands
University Medical Center Utrecht
Utrecht, 3584CX, Netherlands
Related Publications (2)
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.
PMID: 30321312DERIVEDCranendonk 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.
PMID: 24885384DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
W. Joost Wiersinga, MD, PhD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- PRINCIPAL INVESTIGATOR
Jan M. Prins, MD, PhD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- internist, infectious diseases specialist
Study Record Dates
First Submitted
January 8, 2014
First Posted
January 10, 2014
Study Start
August 26, 2014
Primary Completion
July 24, 2017
Study Completion
September 25, 2017
Last Updated
October 10, 2017
Record last verified: 2017-10