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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05023200
Recruitment Status : Completed
First Posted : August 26, 2021
Last Update Posted : December 21, 2023
Sponsor:
Information provided by (Responsible Party):
Elizabeth Cross, University of Sussex

Tracking Information
First Submitted Date August 12, 2021
First Posted Date August 26, 2021
Last Update Posted Date December 21, 2023
Actual Study Start Date June 9, 2021
Actual Primary Completion Date June 6, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 20, 2021)
Sustained recovery [ Time Frame: 90 days ]
No initiation of new antibiotic treatment for cellulitis at the same site through to 90 days
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 20, 2021)
  • Recovery at 28 days [ Time Frame: 28 +/- 3 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
  • Patient-reported time to resolution of cellulitis symptoms [ Time Frame: 28 +/- 3 days ]
    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)
  • Change in quality of life [ Time Frame: Baseline, 90 days (+/- 180 days for a subset recruited within the first year) ]
    Change in quality of life assessed using the Medical Outcomes Study Short Form 12-Item Health Survey (SF-12) compared to baseline
  • Time to return to work / normal activities [ Time Frame: Baseline, 28 days, 90 days (+/- 180 days for a subset recruited within the first year) ]
    Patient-reported date at which they returned to work / normal activities
  • Cellulitis-related readmission [ Time Frame: 90 days (+/- 180 days for a subset recruited within the first year) ]
    New hospital admissions/reattendance containing a cellulitis diagnostic code
  • Cellulitis-related mortality [ Time Frame: 90 days (+/- 180 days for a subset recruited within the first year) ]
    Death within 90 (+/- 180) days of initial admission/attendance
  • Antibiotic usage and antibiotic-related adverse events [ Time Frame: Through study completion, an average of 180 days ]
    Route and duration of antibiotic therapy, adverse events from patient-report, medical and laboratory records
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 20, 2021)
  • Repeatability coefficient [ Time Frame: Measurements taken at 0 to 3 days ]
    Repeatability of the measurements taken by the temperature measurement devices
  • Limits of agreement [ Time Frame: Measurements taken at 0 to 3 days ]
    Estimate of agreement between the temperature measurement devices quantified by estimating the limits of agreement
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title The Personalised Antibiotic Duration for Cellulitis (PAD-C) Study
Official Title The Personalised Antibiotic Duration for Cellulitis (PAD-C) Cohort Study
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.

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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Hospital-based or services delivering antibiotic treatment and ongoing follow-up regardless of location.
Condition
  • Cellulitis
  • Cellulitis of Leg
  • Antibiotic Duration
Intervention Not Provided
Study Groups/Cohorts 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 20, 2023)
230
Original Estimated Enrollment
 (submitted: August 20, 2021)
220
Actual Study Completion Date September 2, 2023
Actual Primary Completion Date June 6, 2023   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT05023200
Other Study ID Numbers 081 CRO / 295690
NIHR300952 ( Other Identifier: NIHR Doctoral Fellowship )
295690 ( Other Grant/Funding Number: IRAS )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Anonymised study data is intended to be made available via an open access research database.
Current Responsible Party Elizabeth Cross, University of Sussex
Original Responsible Party Same as current
Current Study Sponsor University of Sussex
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Elizabeth LA Cross University of Sussex
PRS Account University of Sussex
Verification Date December 2023