Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT02230813 |
Date of registration:
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29/08/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Predictors of Oral Antibiotic Treatment Failure in Emergency Department Patients With Cellulitis
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Scientific title:
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Prevalence and Predictors of Initial Oral Antibiotic Treatment Failure in Adult Emergency Department Patients With Cellulitis: a Pilot Study |
Date of first enrolment:
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March 2015 |
Target sample size:
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152 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02230813 |
Study type:
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Observational |
Study design:
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Phase:
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N/A
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Countries of recruitment
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Ireland
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Contacts
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Name:
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Abel Wakai, MD FRCS FCEM |
Address:
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Telephone:
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Email:
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Affiliation:
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Royal College of Surgeons, Ireland |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age >16 years
- Suitable for treatment with flucloxacillin 500mg -1gram qds monotherapy or a suitable
alternative for penicillin allergic patients as listed in the local prescribing
guidelines.
- Appearance of typical, plaque-like area of erythema over any body part excluding the
perineum within the preceding 5 days with any 2 of the following signs:
- 1.Increased warmth over affected area
- 2.Swelling of affected area
- 3.Pain over affected area
- 4.Regional lymphadenopathy
Exclusion Criteria:
- Requirement for IV antibiotics as decided by the treating clinician.
- Age less than 16 years.
- No telephone or access to a telephone.
- Abscess alone without co-existing signs of cellulitis
- Mammalian bite wounds.
- Infected diabetic foot ulcer
- Necrotising soft tissue infections.
- Perineal cellulitis.
- Suspected septic arthritis or osteomyelitis.
- Decubitus ulcers.
- Bilateral cellulitis (as this entity rarely exists).
- Acute lipodermatosclerosis.
- Acute dermatitis.
- Venous stasis dermatitis.
- Deep vein thrombosis.
- Pregnancy.
- Cognitive impairment.
- Any patient who through language barrier or diminished capacity is unable to
understand the scope of the study
Age minimum:
16 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cellulitis
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Primary Outcome(s)
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Treatment failure
[Time Frame: 2 weeks post commencement of oral treatment]
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Secondary Outcome(s)
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Treatment failure - change in type or dose
[Time Frame: 2 weeks]
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Loss to follow up
[Time Frame: 2 weeks]
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Inter-observer reliability for candidate predictor variables
[Time Frame: At enrolment]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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