Duration of ANtibiotic Therapy for CEllulitis
- Conditions
- ErysipelasCellulitis
- Interventions
- Drug: Placebo (for flucloxacillin)
- Registration Number
- NCT02032654
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 151
- 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
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Allergy for flucloxacillin, other beta-lactam antibiotics or one of the additives, or flucloxacillin induced hepatitis or liver enzyme disorders.
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Concurrent use of antibiotics for other indications
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Alternative diagnosis accounting for the clinical presentation.
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All cases involving any of the following complicating factors:
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Use of antibiotics with Gram-positive activity for more than 4 days in the past 7 days
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Intensive care unit admission during the last 7 days
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Severe peripheral arterial disease (Fontaine IV)
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Severe cellulitis necessitating surgical debridement or fascial biopsy
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Necrotizing fasciitis
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Periorbital or perirectal involvement
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Surgery
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Life expectancy less than one month
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Short course 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 Standard course Flucloxacillin Flucloxacillin (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 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
- Primary Outcome Measures
Name Time Method Part 1/2: Resolution... 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 day 28 No recurrence by day 28, defined as the need for additional antibiotic therapy for cellulitis
- Secondary Outcome Measures
Name Time Method Additional antibiotic usage Up to 90 days Total usage of additional antibiotics for cellulitis between the end of treatment and day 90.
Resolution without relapse day 28 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)
Health care resource utilisation Up to 90 days 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.
Subjective speed of recovery Up to 90 days 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
Recurrence at day 90 90 days Recurrence of cellulitis by day 90, defined as the need for additional antibiotic therapy for cellulitis
Objective speed of recovery Up to 90 days 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
Time to relapse Up to 90 days Time between end of treatment and the need for additional antibiotics for cellulitis
Health related Quality of Life Up to 90 days Using questionnaires Dutch SF-36 and EQ-5D at day 1, day 28, and day 90
Trial Locations
- Locations (11)
Diakonessenhuis
🇳🇱Utrecht, Netherlands
Flevoziekenhuis
🇳🇱Almere, Flevoland, Netherlands
Sint Lucas Andreas Ziekenhuis
🇳🇱Amsterdam, Noord-Holland, Netherlands
Slotervaartziekenhuis
🇳🇱Amsterdam, Noord-Holland, Netherlands
VU university medical center
🇳🇱Amsterdam, Noord-Holland, Netherlands
Onze Lieve Vrouwe Gasthuis
🇳🇱Amsterdam, Noord-Holland, Netherlands
Academic Medical Center - University of Amsterdam
🇳🇱Amsterdam, Noord-Holland, Netherlands
Spaarne Gasthuis Locatie Haarlem Zuid
🇳🇱Haarlem, Noord-Holland, Netherlands
Tergooi
🇳🇱Hilversum, Noord-Holland, Netherlands
St. Antonius Ziekenhuis locatie Utrecht
🇳🇱Utrecht, Netherlands
University Medical Center Utrecht
🇳🇱Utrecht, Netherlands