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.
ID
Bron
Verkorte titel
Aandoening
cellulitis, erysipelas
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Resolution of cellulitis at 14 days, defined as disappearance of warmth and tenderness at the site of infection, with substantial improvement in erythema and edema, and without recurrence by day 28, defined as the need of additional antibiotic therapy for cellulitis.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
Visits scheduled for day 1, day 2-3, day 5-6, day 14, day 28, and day 90.
Onderzoeksproduct en/of interventie
Patients are included on day 1 of their hospital cellulitis episode, and judged on eligiblity for randomization on day 5-6. To qualify for randomization, patients must respond to therapy, defined as absence of fever (temp > 38.0°C) and improvement in cellulitis severity score (see below).
Arm 1: Short course (6 days antibiotics, 6 days placebo), 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
Arm 2: Standard course (12 days antibiotics), 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
Publiek
Meibergdreef 9
D.R. Cranendonk
Amsterdam 1105 AZ
The Netherlands
+31 20 566 5247
d.r.cranendonk@amc.uva.nl
Wetenschappelijk
Meibergdreef 9
D.R. Cranendonk
Amsterdam 1105 AZ
The Netherlands
+31 20 566 5247
d.r.cranendonk@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
Deelname
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Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL4208 |
NTR-old | NTR4360 |
ClinicalTrials.gov | NCT02032654 |
CCMO | NL44512.018.13 |
OMON | NL-OMON45002 |