Trial Outcomes & Findings for The Personalised Antibiotic Duration for Cellulitis (PAD-C) Study (NCT NCT05023200)
NCT ID: NCT05023200
Last Updated: 2026-03-27
Results Overview
Number of Participants with Sustained Recovery
COMPLETED
230 participants
90 days
2026-03-27
Participant Flow
230 recruited: * 13 excluded * 10 died within 90 days before recurrence * 4 withdrew * 1 loss to follow-up 202 included in final analysis
Participant milestones
| Measure |
Cohort
Main cohort
|
|---|---|
|
Overall Study
STARTED
|
230
|
|
Overall Study
COMPLETED
|
202
|
|
Overall Study
NOT COMPLETED
|
28
|
Reasons for withdrawal
| Measure |
Cohort
Main cohort
|
|---|---|
|
Overall Study
Protocol Violation
|
13
|
|
Overall Study
Death
|
10
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
The Personalised Antibiotic Duration for Cellulitis (PAD-C) Study
Baseline characteristics by cohort
| Measure |
Cohort
n=202 Participants
Main cohort
|
|---|---|
|
Age, Continuous
|
66 Years
n=56 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=56 Participants
|
|
Sex: Female, Male
Male
|
118 Participants
n=56 Participants
|
|
Race/Ethnicity, Customized
White ethnicity
|
191 Participants
n=56 Participants
|
|
Race/Ethnicity, Customized
Non-white ethnicity
|
3 Participants
n=56 Participants
|
|
Race/Ethnicity, Customized
Missing
|
8 Participants
n=56 Participants
|
|
Patient-reported previous cellulitis
|
105 Participants
n=56 Participants
|
PRIMARY outcome
Timeframe: 90 daysNumber of Participants with Sustained Recovery
Outcome measures
| Measure |
Cohort
n=202 Participants
Main cohort
|
|---|---|
|
Sustained Recovery
|
156 Participants
|
SECONDARY outcome
Timeframe: 90 daysNumber of participants with new hospital admission/reattendance containing a cellulitis diagnostic code
Outcome measures
| Measure |
Cohort
n=202 Participants
Main cohort
|
|---|---|
|
Cellulitis-related Readmission
|
17 Participants
|
SECONDARY outcome
Timeframe: 28 daysNumber of participants who recovered within 28 days (investigator assessed)
Outcome measures
| Measure |
Cohort
n=162 Participants
Main cohort
|
|---|---|
|
Recovery at 28 Days
|
70 Participants
|
SECONDARY outcome
Timeframe: 28 daysNumber of patients recovered within 28 days (patient-reported)
Outcome measures
| Measure |
Cohort
n=170 Participants
Main cohort
|
|---|---|
|
Patient-reported Recovery by 28 Days
|
72 Participants
|
SECONDARY outcome
Timeframe: Baseline to 90 daysNumber of patients who reported they had returned to work / normal activities within 90 days
Outcome measures
| Measure |
Cohort
n=175 Participants
Main cohort
|
|---|---|
|
Time to Return to Work / Normal Activities
|
125 Participants
|
SECONDARY outcome
Timeframe: Baseline to 90 daysThe 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.
Outcome measures
| Measure |
Cohort
n=202 Participants
Main cohort
|
|---|---|
|
Change in Physical Component Score Assessed Using the Medical Outcomes Study Short Form 12-Item Health Survey (SF-12)
|
8.0 Scores on a scale
Interval 6.1 to 9.8
|
SECONDARY outcome
Timeframe: Baseline to 90 daysThe 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.
Outcome measures
| Measure |
Cohort
n=202 Participants
Main cohort
|
|---|---|
|
Change in Mental Component Score Assessed Using the Medical Outcomes Study Short Form 12-Item Health Survey (SF-12)
|
2.5 Scores on a scale
Interval 0.5 to 4.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measurements taken at 0 to 3 daysRepeatability, defined as the consistency of measurements when taken repeatedly at short intervals by the same device under the same conditions, was assessed by calculating the repeatability coefficient. The repeatability coefficient and estimated 95% Confidence Interval were calculated from one temperature measurement and an instant repeated temperature measurement of the limb of interest on each participant on days 0, 1, 2, 3, all combined. The repeatability coefficient can be interpreted as the range (between the negative and positive values of the coefficient) within which the difference between any two repeated measurements on the same subject is expected to lie for 95% of subjects.
Outcome measures
| Measure |
Cohort
n=513 Affected limb measurements
Main cohort
|
|---|---|
|
Repeatability Coefficient
|
0.68 Repeatability coefficient
Interval 0.61 to 0.75
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measurements taken at 0 to 3 daysRepeatability, defined as the consistency of measurements when taken repeatedly at short intervals by the same device under the same conditions, was assessed by calculating the repeatability coefficient. The repeatability coefficient and estimated 95% Confidence Interval were calculated from one temperature measurement and an instant repeated temperature measurement of the limb of interest on each participant on days 0, 1, 2, 3, all combined. The repeatability coefficient can be interpreted as the range (between the negative and positive values of the coefficient) within which the difference between any two repeated measurements on the same subject is expected to lie for 95% of subjects.
Outcome measures
| Measure |
Cohort
n=513 Unaffected limb measurements
Main cohort
|
|---|---|
|
Repeatability Coefficient
|
0.82 Repeatability coefficient
Interval 0.75 to 0.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measurements taken at 0 to 3 daysThe mean represents the estimated mean difference in affected-limb temperature between measurement methods; the reported 95% interval corresponds to the limits of agreement.
Outcome measures
| Measure |
Cohort
n=202 Participants
Main cohort
|
|---|---|
|
Limits of Agreement
|
-2.52 Degrees celsius
Interval -5.47 to 0.43
|
Adverse Events
Cohort
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Elizabeth Cross
Brighton and Sussex Medical School
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place