CellulitisPAD-CNCT05023200
The Personalised Antibiotic Duration for Cellulitis (PAD-C) Study
An observational study of Cellulitis and Cellulitis of Leg, run by University of Sussex at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cellulitis, Cellulitis of Leg, Antibiotic Duration
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 230 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Jun 2021to 2 Sep 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospital-based or services delivering antibiotic treatment and ongoing follow-up regardless of location.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals Sussex NHS Foundation Trust
Brighton
About this study
Official title: The Personalised Antibiotic Duration for Cellulitis (PAD-C) Cohort Study
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.
Read more
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.
Read the detailed description
This study is a single centre prospective cohort study of patients with cellulitis of the lower limb. The primary objective of this study is to understand what features of individual patients predict a sustained recovery from cellulitis. This information will be used to test and refine a previously developed risk score that predicts clinical outcomes of patients with cellulitis.
Secondary objectives include investigating whether early response to antibiotic treatment (e.g. reduction in skin temperature and patient-reported symptoms) improves the predictive ability of the risk score. The study design also includes a nested technology comparison of temperature measurement devices to identify the best device for measuring affected skin temperature change in patients with cellulitis.
Clinical response will be measured for up to four days from starting antibiotic treatment. This includes the change in temperature and area of affected skin, physiological observations, blood test results (e.g. C-reactive protein) and patient-reported pain and swelling scores. Patients will be followed up at 28 and 90 days (+/- 180 days for those recruited in the first year) to assess recovery, recurrence, cellulitis-related mortality, quality of life, and return to normal activities.
- Conditions
- Cellulitis, Cellulitis of Leg, Antibiotic Duration
- Keywords
- Cellulitis, Antibiotics, Treatment duration, Treatment length
- Medical subject headings
- Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Recovery
Number of Participants with Sustained Recovery
Measured: 90 days
Secondary outcomes (6)
Cellulitis-related Readmission
Number of participants with new hospital admission/reattendance containing a cellulitis diagnostic code
Measured: 90 days
Recovery at 28 Days
Number of participants who recovered within 28 days (investigator assessed)
Measured: 28 days
Patient-reported Recovery by 28 Days
Number of patients recovered within 28 days (patient-reported)
Measured: 28 days
Time to Return to Work / Normal Activities
Number of patients who reported they had returned to work / normal activities within 90 days
Measured: Baseline to 90 days
Change in Physical Component Score Assessed Using the Medical Outcomes Study Short Form 12-Item Health Survey (SF-12)
The Medical Outcomes Study Short Form 12-Item Health Survey (SF-12) comprises a Physical Component Summary and a Mental Component Summary, each reported as norm-based scores (mean 50, SD 10; range 0-100), where higher values indicate better physical or mental health.
Measured: Baseline to 90 days
Change in Mental Component Score Assessed Using the Medical Outcomes Study Short Form 12-Item Health Survey (SF-12)
The Medical Outcomes Study Short Form 12-Item Health Survey (SF-12) comprises a Physical Component Summary and a Mental Component Summary, each reported as norm-based scores (mean 50, SD 10; range 0-100), where higher values indicate better physical or mental health.
Measured: Baseline to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start9 Jun 2021
- Primary completion6 Jun 2023
- Study completion2 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CellulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sussex
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Cross, University of Sussex
- Investigators
- Elizabeth LA Cross, Principal investigator, University of Sussex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023200
- Sponsor's protocol ID
- 081 CRO / 295690
- Other IDs
- NIHR300952, 295690
- Acronym
- PAD-C
- Status last verified
- Mar 2026
- First submitted
- 12 Aug 2021
- Last updated
- 27 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised study data is intended to be made available via an open access research database.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Personalised Antibiotic Duration for Cellulitis (PAD-C) Cohort Study
- ClinicalTrials.gov ID
- NCT05023200
- Acronym / sponsor ID
- PAD-C / 081 CRO / 295690
- Conditions
- Cellulitis, Cellulitis of Leg, Antibiotic Duration
- Keywords
- Cellulitis, Antibiotics, Treatment duration, Treatment length
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- University of SussexUniversity, hospital or other
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- 2 Sep 2023 (actual)
- First posted
- 26 Aug 2021 (actual)
- Results
- Posted 27 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a single centre prospective cohort study of patients with cellulitis of the lower limb. The primary objective of this study is to understand what features of individual patients predict a sustained recovery from cellulitis. This information will be used to test and refine a previously developed risk score that predicts clinical outcomes of patients with cellulitis.
Secondary objectives include investigating whether early response to antibiotic treatment (e.g. reduction in skin temperature and patient-reported symptoms) improves the predictive ability of the risk score. The study design also includes a nested technology comparison of temperature measurement devices to identify the best device for measuring affected skin temperature change in patients with cellulitis.
Clinical response will be measured for up to four days from starting antibiotic treatment. This includes the change in temperature and area of affected skin, physiological observations, blood test results (e.g. C-reactive protein) and patient-reported pain and swelling scores. Patients will be followed up at 28 and 90 days (+/- 180 days for those recruited in the first year) to assess recovery, recurrence, cellulitis-related mortality, quality of life, and return to normal activities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital-based or services delivering antibiotic treatment and ongoing follow-up regardless of location.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sustained Recovery
Time frame: 90 days
Number of Participants with Sustained Recovery
6 secondary outcomes
Cellulitis-related Readmission
Time frame: 90 days
Recovery at 28 Days
Time frame: 28 days
Patient-reported Recovery by 28 Days
Time frame: 28 days
Time to Return to Work / Normal Activities
Time frame: Baseline to 90 days
Change in Physical Component Score Assessed Using the Medical Outcomes Study Short Form 12-Item Health Survey (SF-12)
Time frame: Baseline to 90 days
Change in Mental Component Score Assessed Using the Medical Outcomes Study Short Form 12-Item Health Survey (SF-12)
Time frame: Baseline to 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Anonymised study data is intended to be made available via an open access research database.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth LA Cross principal investigator
University of Sussex
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cellulitis and Cellulitis of Leg, run by University of Sussex at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained Recovery (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.