Trial · NCT02922686
Penicillin for the Emergency Department Outpatient Treatment of CELLulitis
NCT02922686, Phase 4, Unknown, Royal College of Surgeons, Ireland
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Penicillin for the Emergency Department Outpatient Treatment of CELLulitis. Trials, record NCT02922686. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02922686
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Penicillin for the Emergency Department Outpatient Treatment of CELLulitis
- NCT number
- NCT02922686
- Status
- Unknown
- Phases
- Phase 4
- Enrollment
- 414 participants, estimated
- Lead sponsor
- Royal College of Surgeons, Ireland
- Conditions
- Cellulitis, Wound Infection, Abscess
- Interventions
- Flucloxacillin, Phenoxymethylpenicillin, Placebo (for phenoxymethylpenicillin)
- First posted
- 2016-10-04
- Last updated
- 2016-10-04
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Investigator-determined clinical response | Test Of Cure visit (Day 14-21 post randomization) | A trained member of the study team will determine clinical cure at the test of cure visit. This is a clinically-determined response to treatment based on the judgment of the trained member of the study team. Clinical cure will be defined as no treatment failure at any previous visit, and resolution or minimal presence of the erythema, swelling, tenderness, or induration from the baseline assessment, based on the study investigators clinical assessment |
| Secondary | Early Clinical Response (ECR) | Day 2-3 post randomization | Early clinical response is defined as greater than or equal to a 20% reduction in the lesion surface area from that which was measured at enrolment. |
| Secondary | Clinical Treatment Failure | Up to 21 days post randomization | Any patient outcome designated as a clinical treatment failure at any time before and including the test of cure visit, will be categorized as a treatment failure. This commences with the early clinical response visit and includes serial changes in the surface area of the cellulitis lesion (erythema, oedema, tenderness and induration), clinical assessment of progress and health related quality of life measurements. |
| Secondary | Adherence to Medication | End of Treatment (EOT) visit Day 8-10 post randomization | Medication adherence will be measured by counting the number of unused study medication at the end of treatment visit |
| Secondary | Adherence to medication using an electronic medication event monitoring system (MEMS®) | Day 2-3 and day 8-10 post randomization and initiation of therapy | A specific sub-study will be performed measuring adherence and persistence to antibiotic treatment using a MEMS® cap. The cap will be fitted to the dispensed medication bottle. MEMS® caps will be returned with the clinical trials supplies on the follow up visits.medication at the end of treatment visit |
| Secondary | Measurement of Health Related Quality of Life | Day 2-3 post-randomization, Day 8-10 post randomization, Day 14 -21 post randomization | The EuroQol (EQ-5D-5L) will be used to obtain patient reports of health related quality of life and used in the estimation of quality adjusted life years. |
| Secondary | Validation of the Extremity Soft Tissue Infections (ESTI)- score | Day 2-3 post-randomization, Day 8-10 post randomization, Day 14 -21 post randomization | The ESTI will be used to obtain patient reports of health related quality of life and will be mapped on to EQ-5D-5L levels, to assess the accuracy of ESTI for use in cost-effectiveness studies |
| Secondary | Cost-effectiveness analysis | Day 14 - 21 post randomization | Analysis will consist of a within-trial evaluation of the cost QALY for oral flucloxacillin compared with oral flucloxacillin and phenoxymethylpenicillin over a one month time horizon from the perspective of the healthcare payer, the patient and the government. The CE analysis will use resource use data, where costs will be assigned to derive cost and will also use the QALY derived from the EQ5D-5L, to give overall cost per QALY. |
| Secondary | Measurement of Health Resource Use | Day 2-3 post-randomization, Day 8-10 post randomization, Day 14 -21 post randomization | A health economics resource utilization tool is being constructed to collect data on resource use, e.g. direct costs- hospital visits, primary care visits, and indirect costs such as transport and lost work productivity. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02922686
GET https://conductscience.org/api/trials/v1/NCT02922686/registered