Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02032654
Other study ID # NL44512.018.13
Secondary ID 43602013-002106-
Status Terminated
Phase Phase 4
First received January 8, 2014
Last updated October 9, 2017
Start date August 26, 2014
Est. completion date September 25, 2017

Study information

Verified date October 2017
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 151
Est. completion date September 25, 2017
Est. primary completion date July 24, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Flucloxacillin

Placebo (for flucloxacillin)
Sugar capsule manufactured to mimic flucloxacillin 500mg capsules

Locations

Country Name City State
Netherlands Flevoziekenhuis Almere Flevoland
Netherlands Academic Medical Center - University of Amsterdam Amsterdam Noord-Holland
Netherlands Onze Lieve Vrouwe Gasthuis Amsterdam Noord-Holland
Netherlands Sint Lucas Andreas Ziekenhuis Amsterdam Noord-Holland
Netherlands Slotervaartziekenhuis Amsterdam Noord-Holland
Netherlands VU university medical center Amsterdam Noord-Holland
Netherlands Spaarne Gasthuis Locatie Haarlem Zuid Haarlem Noord-Holland
Netherlands Tergooi Hilversum Noord-Holland
Netherlands Diakonessenhuis Utrecht
Netherlands St. Antonius Ziekenhuis locatie Utrecht Utrecht
Netherlands University Medical Center Utrecht Utrecht

Sponsors (2)

Lead Sponsor Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Other Cellulitis severity score subgroup analysis Analysis to see if the height of the cellulitis severity score influences outcome, using a regression analysis with interaction term for severity score. up to day 28
Other Diabetes mellitus subgroup analysis Analysis to see if having diabetes mellitus influences outcome, using a regression analysis with interaction term for diabetes. up to day 28
Other Per protocol analysis Like main outcome, but the following will be included: (i) patients with treatment failure, who have received at least 24 hours of study medication, and (ii) patients with treatment success, who have received at least 80% of study medication. Treatment failure is defined as the persistence or progression of signs and symptoms of the acute process after randomization, or the inability to complete the study owing to adverse events. The response is deemed indeterminate when the patients (i) received less than 80% of the study drug for reasons other than treatment failure, (ii) acquired a concomitant infection outside of the skin requiring antibiotic treatment, (iii) were lost to follow-up, or (iv) died unrelated to the primary diagnosis. up to 28 days
Other Per protocol analysis of the "resolution without relapse" secondary outcome Like secondary outcome, but the following will be included: (i) patients with treatment failure, who have received at least 24 hours of study medication, and (ii) patients with treatment success, who have received at least 80% of study medication. Cured is defined as above (under secondary outcome). Indeterminate is (i) receiving <80% of study drug for reasons other than unblinding/requiring new AB for cellulitis/being unable to continue due to adverse effects, (ii) acquired a concomitant infection outside of the skin requiring antibiotic treatment, (iii) were lost to follow-up, or (iv) died unrelated to the primary diagnosis. Patients who are not cured nor indeterminate are failures. up to 28 days
Other Sensitivity analyses of the "resolution without relapse" secondary outcome Similar, but requiring further improvement of symptoms by either 1 or 2 points by day 28, instead of just stability of symptoms. up to 28 days
Other Adjustments for baseline covariates Sensitivity analysis, adjusting the primary outcome for baseline covariates up to day 28
Primary Part 1/2: Resolution... 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 day 14
Primary Part 2/2: ...without relapse No recurrence by day 28, defined as the need for additional antibiotic therapy for cellulitis day 28
Secondary Resolution without relapse 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) day 28
Secondary Recurrence at day 90 Recurrence of cellulitis by day 90, defined as the need for additional antibiotic therapy for cellulitis 90 days
Secondary Objective speed of recovery 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 Up to 90 days
Secondary Health related Quality of Life Using questionnaires Dutch SF-36 and EQ-5D at day 1, day 28, and day 90 Up to 90 days
Secondary Health care resource utilisation 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. Up to 90 days
Secondary Subjective speed of recovery 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 Up to 90 days
Secondary Additional antibiotic usage Total usage of additional antibiotics for cellulitis between the end of treatment and day 90. Up to 90 days
Secondary Time to relapse Time between end of treatment and the need for additional antibiotics for cellulitis Up to 90 days
See also
  Status Clinical Trial Phase
Completed NCT02864420 - Hospitalization at Home: The Acute Care Home Hospital Program for Adults N/A
Completed NCT00746109 - Study of Wound Packing After Superficial Skin Abscess Drainage Phase 4
Completed NCT03296280 - Evaluation of Implementation of a National Point-of-Care Ultrasound Training Program
Not yet recruiting NCT01947660 - Continuous Regional Anesthesia for Septic Limb Orthopedic Surgery N/A
Completed NCT01876628 - Adjunctive Clindamycin for Cellulitis: C4C Trial. Phase 4
Active, not recruiting NCT01706913 - Study Assessing Impact of Dermatology Consultation for Patients Admitted With Cellulitis N/A
Completed NCT03474523 - Effectiveness of Diathermy-Radiofrecuency Compared With Cavitation in Cellulitis Treatment N/A
Recruiting NCT03312946 - Effect of Vibro-oscillatory Therapy for Improvement of Body Contour and Appearance of Cellulite. N/A
Active, not recruiting NCT05226260 - Decreasing Antibiotic Duration for Skin and Soft Tissue Infection Using Behavioral Economics in Primary Care N/A
Active, not recruiting NCT03785834 - The Effect of Histopathologic Analysis and Tissue Cultures on Inpatient Management of Cellulitis and Pseudocellulitis
Completed NCT01549613 - Evaluation of Daptomycin for the Emergency Department Treatment of Complicated Skin and Skin Structure Infections Phase 4
Completed NCT01029782 - Comparison of Intravenous Cefazolin Plus Oral Probenecid With Oral Cephalexin for the Treatment of Cellulitis Phase 2
Completed NCT00676130 - Study of New Antibiotic Regimen for the Treatment of Uncomplicated Cellulitis in Emergency Department Patients N/A
Not yet recruiting NCT03917134 - Prevention of Vaginal Cellulitis or Vaginal Cuff Abscess After Laparoscopic Hysterectomy N/A
Completed NCT02230813 - Predictors of Oral Antibiotic Treatment Failure in Emergency Department Patients With Cellulitis N/A
Completed NCT01557426 - Soft Tissue Ultrasound of Infections Phase 1
Completed NCT01339091 - Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections Phase 3
Completed NCT00984022 - Aquacel Versus Iodoform Gauze for Filling Abscess Cavity Following Incision and Drainage Phase 2
Completed NCT04091672 - RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction N/A
Completed NCT05023200 - The Personalised Antibiotic Duration for Cellulitis (PAD-C) Study