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

Recruitment status

COMPLETED

Target enrollment

230 participants

Primary outcome timeframe

90 days

Results posted on

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

Participant milestones
Measure
Cohort
Main cohort
Overall Study
STARTED
230
Overall Study
COMPLETED
202
Overall Study
NOT COMPLETED
28

Reasons for withdrawal

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

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 days

Number of Participants with Sustained Recovery

Outcome measures

Outcome measures
Measure
Cohort
n=202 Participants
Main cohort
Sustained Recovery
156 Participants

SECONDARY outcome

Timeframe: 90 days

Number of participants with new hospital admission/reattendance containing a cellulitis diagnostic code

Outcome measures

Outcome measures
Measure
Cohort
n=202 Participants
Main cohort
Cellulitis-related Readmission
17 Participants

SECONDARY outcome

Timeframe: 28 days

Number of participants who recovered within 28 days (investigator assessed)

Outcome measures

Outcome measures
Measure
Cohort
n=162 Participants
Main cohort
Recovery at 28 Days
70 Participants

SECONDARY outcome

Timeframe: 28 days

Number of patients recovered within 28 days (patient-reported)

Outcome measures

Outcome measures
Measure
Cohort
n=170 Participants
Main cohort
Patient-reported Recovery by 28 Days
72 Participants

SECONDARY outcome

Timeframe: Baseline to 90 days

Number of patients who reported they had returned to work / normal activities within 90 days

Outcome measures

Outcome measures
Measure
Cohort
n=175 Participants
Main cohort
Time to Return to Work / Normal Activities
125 Participants

SECONDARY outcome

Timeframe: Baseline to 90 days

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.

Outcome measures

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 days

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.

Outcome measures

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 days

Repeatability, 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

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 days

Repeatability, 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

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 days

The 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

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 events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: +44 (0)1273 877889

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place