Duration of ANtibiotic Therapy for CEllulitis (NCT02032654) | Clinical Trial Compass
TerminatedPhase 4
Duration of ANtibiotic Therapy for CEllulitis
Stopped: Budget exceeded
Netherlands151 participantsStarted 2014-08-26
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part 1/2: Resolution...
Timeframe: day 14
2
Part 2/2: ...without relapse
Timeframe: day 28
Trial details
NCT IDNCT02032654
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)