N/A
N=230
The Personalised Antibiotic Duration for Cellulitis (PAD-C) Study
Cellulitis · Cellulitis of Leg · Antibiotic Duration
Bottom Line
View on ClinicalTrials.gov: NCT05023200 ↗Enrolled (actual)
230
Serious AEs
—
Results posted
Mar 2026
Primary outcome: Primary: Sustained Recovery — 156 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Sussex
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sustained Recovery |
156 | — |
| SECONDARY Cellulitis-related Readmission |
17 | — |
| SECONDARY Recovery at 28 Days |
70 | — |
| SECONDARY Patient-reported Recovery by 28 Days |
72 | — |
| SECONDARY Time to Return to Work / Normal Activities |
125 | — |
| SECONDARY Change in Physical Component Score Assessed Using the Medical Outcomes Study Short Form 12-Item Health Survey (SF-12) |
8.0 | — |
| SECONDARY Change in Mental Component Score Assessed Using the Medical Outcomes Study Short Form 12-Item Health Survey (SF-12) |
2.5 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05023200). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.