Duration of ANtibiotic Therapy for CEllulitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-26

Study Completion Date

2017-09-25

Brief Summary

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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

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Conditions

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Cellulitis Erysipelas

Keywords

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antibiotics flucloxacillin therapy duration cellulitis erysipelas skin infections hospital

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Standard course

Flucloxacillin (1000mg iv OR, later, 500mg capsules), every 6 hours, for 6 days, followed by: Flucloxacillin 500mg capsules, every 6 hours, for 6 days

Group Type ACTIVE_COMPARATOR

Flucloxacillin

Intervention Type DRUG

Short course

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

Group Type EXPERIMENTAL

Flucloxacillin

Intervention Type DRUG

Placebo (for flucloxacillin)

Intervention Type DRUG

Sugar capsule manufactured to mimic flucloxacillin 500mg capsules

Interventions

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Flucloxacillin

Intervention Type DRUG

Placebo (for flucloxacillin)

Sugar capsule manufactured to mimic flucloxacillin 500mg capsules

Intervention Type DRUG

Other Intervention Names

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Floxapen

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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W.J. Wiersinga, MD, PhD

internist, infectious diseases specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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W. Joost Wiersinga, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Jan M. Prins, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Locations

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