Cellulitis Clinical Trial
— CHOICEOfficial title:
CHOICE Trial: Cellulitis at Home Or Inpatient in Children From ED
NCT number | NCT02334124 |
Other study ID # | HREC34254F |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2015 |
Est. completion date | November 2022 |
Verified date | November 2022 |
Source | Murdoch Childrens Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Many children every year present to the Emergency Department (ED) at The Royal Children's Hospital (RCH) with cellulitis (skin infection). If it is mild, the children can go home with oral antibiotic treatment. If it is complicated and severe, these children are admitted to hospital for intravenous (IV, through a drip) antibiotic treatment. There is a middle group with uncomplicated moderate/severe cellulitis who require IV antibiotics but who are not acutely unwell. In order to determine whether it is just as effective for children with uncomplicated moderate to severe cellulitis to receive antibiotic treatment at home (via Hospital-In-The-Home) as it is to receive antibiotic treatment in hospital, there is a need to conduct a larger study and randomly assign children to receive either HITH or hospital ward care. The primary research question to be addressed is: In children with moderate/severe uncomplicated cellulitis, is the failure rate at 2 days following the first dose of antibiotic non-inferior for children treated with IV antibiotics at home compared to the failure rate at 2 days following the first dose for children treated with IV antibiotics in hospital?
Status | Completed |
Enrollment | 190 |
Est. completion date | November 2022 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months to 18 Years |
Eligibility | Inclusion Criteria: - Children aged 6 months to 18 years - Children presenting to RCH ED with moderate/severe cellulitis - Moderate/severe: defined in this study, as those assessed by ED clinician to need IV antibiotics - Reasons for starting IV antibiotics include: 1. Failed oral therapy (not improving despite 24h of oral therapy) 2. Rapidly spreading redness (from patient/parent history) 3. Significant swelling/redness/pain 4. Systemic symptoms/signs (eg. fever, lethargy) 5. Difficult to treat areas (eg. face, ear, toe) Exclusion Criteria: Children will be excluded: 1. With orbital cellulitis or unable to exclude orbital cellulitis, 2. With penetrating injury/bites, 3. With suspected fasciitis or myositis, 4. With toxicity: tachycardia when afebrile or hypotension (both as per the limits set out by RCH Resuscitation Card), poor central perfusion (capillary refill >2 seconds) 5. With immunosuppression, 6. With varicella, 7. With suspected/confirmed foreign body, 8. With abscess not drained, 9. With dental abscess, 10. With concurrent sinusitis or otitis media or lymphadenitis necessitating different antibiotic treatment to flucloxacillin monotherapy or ceftriaxone monotherapy, 11. With liver co-morbidities 12. With other medical diagnoses warranting admission to hospital for observation or treatment relating to the known medical condition 13. With difficult intravenous access, 14. Age <6 months old, 15. Who could be managed on oral antibiotics (ie assessed as mild cellulitis) |
Country | Name | City | State |
---|---|---|---|
Australia | The Royal Children's Hospital Melbourne | Parkville | Victoria |
Lead Sponsor | Collaborator |
---|---|
Murdoch Childrens Research Institute |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Microbiome | • Differential effect of narrow spectrum (flucloxacillin) and broad spectrum (ceftriaxone) on the nasal and gastrointestinal microbiome from nasal swabs and stool samples collected within 48 hours, after 7-14 days, 3 months and 1 year after starting antibiotics. This outcome will be published separately. | 1 year | |
Primary | Treatment failure (inadequate clinical improvement, adverse event) | The primary outcome is failure of treatment defined as no clinical improvement of cellulitis within 2 days of treatment from the start of the first antibiotic dose given in the ED. Any change of initial empiric antibiotics within 2 days from commencement due to:
inadequate clinical improvement or adverse events as determined by treating physician will be considered a treatment failure. |
Within 2 days of commencing empiric antibiotic | |
Secondary | Time to no progression | Number of days (including fractions of days) elapsed from the start of the first dose in ED (Day 1) to the time at which the cellulitis stops spreading past the marked area, judged during daily assessment of cellulitis | Within 3 days | |
Secondary | Time to discharge | Number of days (including fractions of days) elapsed from the time of arrival in ED to the moment the patient is discharged.
(Discharge is defined as when patients admitted to hospital are deemed not to require any hospital funded care/intervention from a hospital based nurse/doctor. The time and date is registered on the electronic hospital database IBA. Admission to hospital is defined as patients who are deemed to need hospital funded care/intervention from a hospital based nurse/doctor) |
14 days | |
Secondary | Readmission rate | Number of children readmitted to hospital within 14 days of discharge date due to the same cellulitis | 28 days | |
Secondary | Representation to ED | Number of children representing to ED within 14 days of discharge and diagnosed to have incomplete resolution or recurrence of same cellulitis | 28 days | |
Secondary | ED Length of stay | Length of stay in ED (from first presentation in ED to time the patient leaves ED to go either home or to ward) | 2 days | |
Secondary | Duration of iv antibiotics | Number of days (including fractions of days) elapsed from the start of the first dose in ED (Day 1) to the time of the last dose | 14 days | |
Secondary | IV cannula resiting (Rates of iv cannula needing at least one resiting) | Rates of iv cannula needing at least one resiting | 14 days | |
Secondary | Complications of cellulitis (Development of abscess requiring drainage) | Development of abscess requiring drainage after starting IV antibiotics and bacteremia | 14 days | |
Secondary | Adverse events | Occurrences of anaphylaxis, allergic reaction (suspected or confirmed) necessitating change of empiric antibiotic, sepsis, death | 14 days | |
Secondary | Comparing patient costs | Comparing ward patient costs and HITH patient costs | 14 days | |
Secondary | Quality of life (QOL) indicators | Quality of life (QOL) indicators (through survey asking parents/patients how much admission to hospital or HITH disrupt their routine) | 1 year | |
Secondary | Cellulitis clinical score | Clinical assessment in all study participants in terms of presence of systemic features, surface area affected (longest length axis multiply by the longest perpendicular axis measured in cm2), severity of swelling (judged by clinician as any one of the following: mild, moderate or severe), intensity of erythema (judged by clinician from a scale of 0 to 5, 0=no erythema and 5=severe erythema), impairment of function of affected area, tenderness of cellulitis area (judged by clinician from a scale of 0 to 5, 0=not tender and 5=very tender). | 14 days | |
Secondary | Microbiology | Rate of ceftriaxone susceptibility in bacteria isolated from a nasal or skin swab of the affected area
Rate of S. aureus nasal carriage (methicillin-sensitive and methicillin-resistant) collected within 48 hours, after 7-14 days, 3 months and 1 year after starting antibiotics Rate of resistant bacteria present in stool samples collected within 48 hours, after 7-14 days, 3 months and 1 year after starting antibiotics. Rates of clinical infection with resistant organisms up to 1 year after starting antibiotics. This outcome may be published separately as require longer follow up. |
1 year |
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
|