Cellulitis Clinical Trial
— PAD-COfficial title:
The Personalised Antibiotic Duration for Cellulitis (PAD-C) Cohort Study
Verified date | December 2023 |
Source | University of Sussex |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Cellulitis is an increasingly common and unpleasant bacterial infection of the skin, usually affecting the legs. Patients experience pain and swelling, loss of mobility, fever, and chills. Patients may be left with chronic skin damage and 1 in 5 experience recurrences. Cellulitis is treated with antibiotics, but it is unclear as to how long treatment should be for. As a result, many patients get much longer antibiotic treatment than needed. This exposes patients to the risks of taking unnecessary antibiotics. This study aims to find out what features of individual patients predict a good, sustained recovery from cellulitis. These may include medical conditions and clinical response to the first few days of antibiotic treatment, such as changes in skin temperature. Patients who are being treated in hospital for cellulitis will be invited to take part. Information will be collected about patients who will be followed up for 3-6 months. Devices for measuring skin temperature will also be compared to see which one works best. This information will be used to help develop a set of rules that doctors can use to guide the length of antibiotic treatment. This should ensure that future patients receive the amount of antibiotics needed and no more.
Status | Completed |
Enrollment | 230 |
Est. completion date | September 2, 2023 |
Est. primary completion date | June 6, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adults (age =18 years) identified by their treating clinician as having lower limb cellulitis that requires IV or oral antibiotic treatment either from the hospital or another service based outside of the hospital, which will conduct ongoing follow-up regardless of location. Exclusion Criteria: Patients: - who have already received 3 or more calendar days of antibiotics from the hospital for cellulitis. - receiving antibiotic therapy for another indication that is anticipated to continue for longer than the antibiotic treatment for cellulitis and that, in the judgement of the investigator, would impact the study assessments. - for whom a surgical procedure to treat their cellulitis is planned (i.e. debridement of suspected necrotising skin / soft tissue infection). - who, in the judgement of the investigator, do not have a clear diagnosis of cellulitis (to enable the exclusion of infections, such as severe/deep diabetic foot infection, which may be loosely labelled as cellulitis, but treated with different guideline antibiotic agents and durations). - lack capacity to give informed consent to participate. - are receiving end-of-life care. - are already involved in a CTIMP of relevance to the treatment of their cellulitis. - are unlikely, in the opinion of the investigator, to comply with study procedures. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University Hospitals Sussex NHS Foundation Trust | Brighton |
Lead Sponsor | Collaborator |
---|---|
University of Sussex |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Repeatability coefficient | Repeatability of the measurements taken by the temperature measurement devices | Measurements taken at 0 to 3 days | |
Other | Limits of agreement | Estimate of agreement between the temperature measurement devices quantified by estimating the limits of agreement | Measurements taken at 0 to 3 days | |
Primary | Sustained recovery | No initiation of new antibiotic treatment for cellulitis at the same site through to 90 days | 90 days | |
Secondary | Recovery at 28 days | The absence of warmth and tenderness at the site, with improvement in swelling and acute colour change, that did not require new antibiotic treatment | 28 +/- 3 days | |
Secondary | Patient-reported time to resolution of cellulitis symptoms | Patient-reported time to resolution of cellulitis and symptoms of pain and swelling, using a numeric and verbal marked scale (1 to 10, higher score indicates higher severity of symptom) | 28 +/- 3 days | |
Secondary | Change in quality of life | Change in quality of life assessed using the Medical Outcomes Study Short Form 12-Item Health Survey (SF-12) compared to baseline | Baseline, 90 days (+/- 180 days for a subset recruited within the first year) | |
Secondary | Time to return to work / normal activities | Patient-reported date at which they returned to work / normal activities | Baseline, 28 days, 90 days (+/- 180 days for a subset recruited within the first year) | |
Secondary | Cellulitis-related readmission | New hospital admissions/reattendance containing a cellulitis diagnostic code | 90 days (+/- 180 days for a subset recruited within the first year) | |
Secondary | Cellulitis-related mortality | Death within 90 (+/- 180) days of initial admission/attendance | 90 days (+/- 180 days for a subset recruited within the first year) | |
Secondary | Antibiotic usage and antibiotic-related adverse events | Route and duration of antibiotic therapy, adverse events from patient-report, medical and laboratory records | Through study completion, an average of 180 days |
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