CellulitisPhase 4DANCENCT02032654
Duration of ANtibiotic Therapy for CEllulitis
A Phase 4 study testing Flucloxacillin in people with Cellulitis and Erysipelas, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 11 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cellulitis, Erysipelas
- What is being tested?
- Flucloxacillin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 151 participants
- Where
- 11 sitesNetherlands
- Study dates
- 26 Aug 2014to 25 Sep 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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 locations and contacts
11 sites in 1 country.
11 sites in 1 country
Netherlands11 sites
Flevoziekenhuis
Almere Stad, Flevoland, 1300EG
Sint Lucas Andreas Ziekenhuis
Amsterdam, North Holland, 1061AE
Slotervaartziekenhuis
Amsterdam, North Holland, 1066EC
VU university medical center
Amsterdam, North Holland, 1081HV
Onze Lieve Vrouwe Gasthuis
Amsterdam, North Holland, 1087CH
Academic Medical Center - University of Amsterdam
Amsterdam, North Holland, 1105AZ
Spaarne Gasthuis Locatie Haarlem Zuid
Haarlem, North Holland, 2035RC
Tergooi
Hilversum, North Holland, 1213XZ
St. Antonius Ziekenhuis locatie Utrecht
Utrecht, 3543AZ
Diakonessenhuis
Utrecht, 3582KE
University Medical Center Utrecht
Utrecht, 3584CX
About this study
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
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.
- Conditions
- Cellulitis, Erysipelas
- Being tested
- Flucloxacillin, Placebo (for flucloxacillin)
- Keywords
- antibiotics, flucloxacillin, therapy duration, cellulitis, erysipelas, skin infections, hospital
- Medical subject headings
- Cellulitis, Erysipelas
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlucloxacillinDrug
Also called Floxapen
Placebo (for flucloxacillin)Drug
Sugar capsule manufactured to mimic flucloxacillin 500mg capsules
| Study group | Role | What they receive |
|---|---|---|
| Standard course | Active comparator | Flucloxacillin (1000mg iv OR, later, 500mg capsules), every 6 hours, for 6 days, followed by: Flucloxacillin 500mg capsules, every 6 hours, for 6 days Receives: Drug: Flucloxacillin |
| Short course | Experimental | 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 Receives: Drug: Flucloxacillin; Drug: Placebo (for flucloxacillin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day 14
Part 2/2: ...without relapse
No recurrence by day 28, defined as the need for additional antibiotic therapy for cellulitis
Measured: day 28
Secondary outcomes (8)
Resolution without relapse
Other operators used to define resolution at day 14 (no fever; reduction in combined erythema/edema/warmth/tenderness score of at least 2 points, or reach 0) and relapse at day 28 (no fever; stable or further improved combined score; no new antibiotics for cellulitis)
Measured: day 28
Recurrence at day 90
Recurrence of cellulitis by day 90, defined as the need for additional antibiotic therapy for cellulitis
Measured: 90 days
Objective speed of recovery
Improvement in cellulitis severity score (a 7 item scoring system, each with a score between 0-3; items are erythema, warmth, tenderness, edema, ulceration, drainage and fluctuance). Determined at day 1, day 2-3, day 5-6, day 14, and day 28
Measured: Up to 90 days
Health related Quality of Life
Using questionnaires Dutch SF-36 and EQ-5D at day 1, day 28, and day 90
Measured: Up to 90 days
Health care resource utilisation
Determined by total antibiotic use and effect on direct and indirect health-care associated costs, using modified versions of iMTA's Productivity Cost Questionnaire (iPCQ) and Medical Consumption Questionnaire (iMCQ). Measured at day 5-6, day 28 and day 90.
Measured: Up to 90 days
Subjective speed of recovery
Visual Analog Scales (0-10) on pain and on swelling. Determined at day 1, day 2-3, day 5-6, day 14, day 28, and day 90
Measured: Up to 90 days
Additional antibiotic usage
Total usage of additional antibiotics for cellulitis between the end of treatment and day 90.
Measured: Up to 90 days
Time to relapse
Time between end of treatment and the need for additional antibiotics for cellulitis
Measured: Up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study start26 Aug 2014
- Primary completion24 Jul 2017
- Study completion25 Sep 2017
Why it stopped: Budget exceeded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CellulitisStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, W.J. Wiersinga, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- W. Joost Wiersinga, MD, PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Jan M. Prins, MD, PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02032654
- Sponsor's protocol ID
- NL44512.018.13
- Other IDs
- 4360, 2013-002106-31, 836011024
- Acronym
- DANCE
- Status last verified
- Oct 2017
- First submitted
- 8 Jan 2014
- Last updated
- 10 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30321312Cranendonk 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.
PubMed 24885384
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02032654
- Acronym / sponsor ID
- DANCE / NL44512.018.13
- Conditions
- Cellulitis, Erysipelas
- Keywords
- antibiotics, flucloxacillin, therapy duration, cellulitis, erysipelas, skin infections, hospital
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Budget exceeded
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 26 Aug 2014 (actual)
- Primary completion
- 24 Jul 2017 (actual)
- Study completion
- 25 Sep 2017 (actual)
- First posted
- 10 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard course | Active comparator | Drug: FlucloxacillinFlucloxacillin (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 | Experimental | Drug: Flucloxacillin, Drug: Placebo (for flucloxacillin)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (20 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FlucloxacillinAlso: Floxapen | Drug | Short course, Standard course |
| Placebo (for flucloxacillin)Sugar capsule manufactured to mimic flucloxacillin 500mg capsules | Drug | Short course |
Primary outcome
Part 1/2: Resolution...
Time frame: day 14
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
Part 2/2: ...without relapse
Time frame: day 28
No recurrence by day 28, defined as the need for additional antibiotic therapy for cellulitis
8 secondary outcomes
Resolution without relapse
Time frame: day 28
Recurrence at day 90
Time frame: 90 days
Objective speed of recovery
Time frame: Up to 90 days
Health related Quality of Life
Time frame: Up to 90 days
Health care resource utilisation
Time frame: Up to 90 days
Subjective speed of recovery
Time frame: Up to 90 days
Additional antibiotic usage
Time frame: Up to 90 days
Time to relapse
Time frame: Up to 90 days
Results and safety
The study was stopped early (reason given: Budget exceeded). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2017.
- Derived from this study: PubMed 30321312Cranendonk 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.
- Derived from this study: PubMed 24885384Cranendonk 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.
- Published study protocol in BMC Infectious DiseasesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
W. Joost Wiersinga, MD, PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Jan M. Prins, MD, PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Flucloxacillin in people with Cellulitis and Erysipelas, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 11 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Budget exceeded). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1/2: Resolution... (time frame: day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02032654, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2017.