To determine if 6 days of antibiotics has equal efficacy compared to 12 days for patients hospitalized with cellulitis.
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is resolution of cellulitis at 14 days after study
enrolment, and without recurrence by day 28 (defined as the need for additional
antibiotics for cellulitis).
Secondary outcome
Secondary endpoints are length of hospital stay, health-related quality of
life, total antibiotic use and effect on direct and indirect health-care
associated costs.
Background 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 to 14 days of antibiotics, which is currently 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.
Study objective
To determine if 6 days of antibiotics has equal efficacy compared to 12 days
for patients hospitalized with cellulitis.
Study design
A randomized, double-blind, placebo-controlled non-inferiority trial.
Intervention
12 days of antibiotic therapy (i.e. flucloxacilline) or 6 days of antibiotic
therapy, followed by 6 days of placebo.
Study burden and risks
All participating patients will have to complete four sets of questionnaires
(some by phone) and have four extra venous punctures. Also, patients admitted
to the AMC will have to undergo a skin biopsy. Possible risks include
inferiority of 6 days of antibiotic treatment to 12 days of treatment, i.e.
slower recovery of patients in the intervention group. Given positive results
of studies in other infectious diseases however, we do not expect this to be
the case. The small risk of 6 days being inferior offsets the enormous profits
a shortening of therapy for cellulitis would yield.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- 18 years of age or older
- Admitted to the hospital for skin infection (cellulitis)
- Capable of giving written informed consent and able to comply with the requirements and restrictions listed in the informed consent form
- Not participating in another clinical therapeutic trial on antibiotics;Healthy volunteers:
- 18 years and older
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 complicating factors (see protocol);Healthy volunteers:
- No abscess, cellulitis, dermatitis or psoriasis in/on the leg in the past 3 months
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-002106-31-NL |
| CCMO | NL44512.018.13 |
| OMON | NL-OMON20276 |