The Personalised Antibiotic Duration for Cellulitis (PAD-C) Study

NCT05023200 | Completed Results

• 3 other identifiers: 081 CRO / 295690NIHR300952295690
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cellulitis; Antibiotic Duration; Cellulitis of Leg

Keywords

Cellulitis; Antibiotics; Treatment duration; Treatment length

Outcome Measures

Primary Outcomes (1)

• Sustained Recovery

  Number of Participants with Sustained Recovery

  90 days

Secondary Outcomes (6)

• Cellulitis-related Readmission

  90 days

• Recovery at 28 Days

  28 days

• Patient-reported Recovery by 28 Days

  28 days

• Time to Return to Work / Normal Activities

  Baseline to 90 days

• Change in Physical Component Score Assessed Using the Medical Outcomes Study Short Form 12-Item Health Survey (SF-12)

  Baseline to 90 days

Other Outcomes (2)

• Repeatability Coefficient

  Measurements taken at 0 to 3 days

• Limits of Agreement

  Measurements taken at 0 to 3 days

Study Arms (1)

Population

Adults (age ≥18 years) identified by their treating clinician as having lower limb cellulitis that requires intravenous 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospital-based or services delivering antibiotic treatment and ongoing follow-up regardless of location.

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• University of Sussex: lead

Study Sites (1)

University Hospitals Sussex NHS Foundation Trust

Brighton, United Kingdom

Location

MeSH Terms

Conditions

Cellulitis

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Infections; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr Elizabeth Cross
• Organization: Brighton and Sussex Medical School

E.Cross1@bsms.ac.uk

+44 (0)1273 877889

Study Officials

• Elizabeth LA Cross

  University of Sussex

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Investigator

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 26, 2021
• Study Start: June 9, 2021
• Primary Completion: June 6, 2023
• Study Completion: September 2, 2023
• Last Updated: March 27, 2026
• Results First Posted: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)