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Cellulitis Optimal Antibiotic Treatment

NCT ID: NCT05584007

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

356 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-29

Study Completion Date

2026-10-01

Brief Summary

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To determine whether a short course of oral flucloxacillin (5 days) is non-inferior to a standard course (7 days) in terms of pain over days 6-14 (indicative of persistence or recurrence associated with the symptoms of most importance to patients) in adults with cellulitis of the leg presenting in primary care.

Detailed Description

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Cellulitis is a deep infection of the skin and subcutaneous tissues and most often occurs in the legs. It is a painful condition that is associated with inflammation and swelling of the site, and often systemic symptoms such as fever, headache, muscle aches, malaise, and fatigue. Patients report feeling unwell and that it has a significant impact on their mobility and ability to carry out their usual activities. NICE guidelines recommend oral flucloxacillin 500-1000 mg four times daily for 5-7 days as first-line treatment for most patients with cellulitis in the community, but most prescriptions are dispensed for a 7-day course. We will be assessing the effectiveness and safety of a 5-day treatment vs. the standard 7-day treatment. We also aim to evaluate the cost-consequences of a shorter course from an NHS and personal perspective. Participants will be randomly allocated to one of two groups. In addition to usual care, participants will either be assigned to a 5-day oral flucloxacillin course or a standard 7-day flucloxacillin course. Participants will be prescribed a 5-day course of oral flucloxacillin, and two additional tablets will be posted to the participants which will either be the antibiotic or a placebo tablet. Participants will be asked to fill out daily questionnaires and express their experiences with the shortened course and taking part in the trial.

Conditions

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Cellulitis of Leg

Keywords

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Primary care Antibiotic treatment Antibiotic resistance Pain Cost consequences

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A phase III blinded, multi-center, non-inferiority trial assessing the effectiveness and safety of 5 days vs 7 days of oral flucloxacillin 500mg QDS for lower leg cellulitis, and to evaluate the cost-consequences of a shorter course from an NHS and personal perspective. Participants will be recruited in NHS primary care settings in England and Wales. We will primarily recruit through general practices but will explore the possibility of recruiting through out-of-the-hours and urgent care settings.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
To facilitate ease of recruitment and avoid treatment delay, participants will be provided with an NHS prescription for flucloxacillin 500mg QDS for the first 5 days. A blinded medication pack will be sent by next day delivery, containing flucloxacillin 500mg QDS, or matched placebo QDS for the final 2 days. Participants will be informed that the capsules in this pack may look different from the capsules they were taking on days 1-5. Participants experiencing significant clinical deterioration, as judged by their clinician, may have their antibiotic treatment changed or be prescribed additional antibiotic courses. Any changes or additional use of antibiotics will be recorded, and the patient and clinician will remain blinded unless unblinding is deemed necessary.

Study Groups

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Intervention

Flucloxacillin 500mg four times a day (QDS) for 5 days (unblinded NHS prescription) followed by blinded placebo QDS for 2 days (5 days of antibiotic)

Group Type PLACEBO_COMPARATOR

Flucloxacillin Only Product in Oral Dose Form

Intervention Type DRUG

Patients will be prescribed flucloxacillin 500mg QDS for 5 days followed by blinded flucloxacillin 500mg for 2 days, reaching a total of 7 days of antibiotic treatment

Placebo Only Product in Oral Dose Form

Intervention Type DRUG

Patients will be prescribed flucloxacillin 500mg QDS for 5 days followed by a blinded placebo for 2 days, reaching a total of 5 days of antibiotic treatment

Control

Flucloxacillin 500mg QDS for 5 days (unblinded NHS prescription) followed by flucloxacillin 500mg QDS (blinded) for 2 days (7 days of antibiotic)

Group Type ACTIVE_COMPARATOR

Flucloxacillin Only Product in Oral Dose Form

Intervention Type DRUG

Patients will be prescribed flucloxacillin 500mg QDS for 5 days followed by blinded flucloxacillin 500mg for 2 days, reaching a total of 7 days of antibiotic treatment

Interventions

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Flucloxacillin Only Product in Oral Dose Form

Patients will be prescribed flucloxacillin 500mg QDS for 5 days followed by blinded flucloxacillin 500mg for 2 days, reaching a total of 7 days of antibiotic treatment

Intervention Type DRUG

Placebo Only Product in Oral Dose Form

Patients will be prescribed flucloxacillin 500mg QDS for 5 days followed by a blinded placebo for 2 days, reaching a total of 5 days of antibiotic treatment

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Must be aged 18 years or older
* Currently showing symptoms of cellulitis (such as pain, tenderness, redness, other change in skin color, warmth to touch) in one leg for 10 days or less
* Pain rated as 3/10 or higher on a numerical rating scale (0-10) at baseline assessment
* Be willing to be randomized to either trial arm (5-day or 7-day treatment)
* Able to complete trial procedures in the English language.

Exclusion Criteria

* Have penicillin allergy
* Have bilateral cellulitis
* Have had antibiotics for cellulitis within the past month
* Have post-operative cellulitis (within 30 days of operative procedures on the same leg)
* Have cellulitis resulting from human/animal bite injury
* Have Cellulitis associated with chronic (\>6 weeks) leg ulceration
* Require immediate hospital admission or out-patient intravenous antibiotic therapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of East Anglia

OTHER

Sponsor Role collaborator

University of Nottingham

OTHER

Sponsor Role collaborator

Norfolk and Norwich University Hospitals NHS Foundation Trust

OTHER

Sponsor Role collaborator

University Hospital Southampton NHS Foundation Trust

OTHER

Sponsor Role collaborator

University of Southampton

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Royal South Hants Hospital

Southampton, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Sophie Varkonyi-Clifford

Role: CONTACT

Phone: 0 23 8059 1532

Email: [email protected]

Ella Bourke

Role: CONTACT

Phone: 02381550206

Email: [email protected]

Facility Contacts

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Ian Ward

Role: primary

Other Identifiers

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ERGO 67073

Identifier Type: -

Identifier Source: org_study_id