Cellulitis Optimal Antibiotic Treatment

NCT05584007 | Recruiting Phase 3 DMC

• 1 other identifier: ERGO 67073
• Study Type: interventional
• Target: 356
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cellulitis of Leg

Keywords

Primary care; Antibiotic treatment; Antibiotic resistance; Pain; Cost consequences

Outcome Measures

Primary Outcomes (1)

• Pain assessment

  Self-reported pain (measured using the Pain Numeric Rating Scale (0-10))

  Days 7-16

Secondary Outcomes (10)

• Use of additional antibiotics

  Up to day 28

• Patient-reported assessment of how well they are feeling

  Days 6-14

• Health related quality of life

  Days 6-14

• Health related quality of life used to estimate Quality Adjusted- Life Years (QALYs)

  Days 6-14

• Leg swelling and warmth

  Day 7, 14, 21, 28

Study Arms (2)

Intervention

PLACEBO COMPARATOR

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)

Drug: Flucloxacillin Only Product in Oral Dose Form; Drug: Placebo Only Product in Oral Dose Form

Control

ACTIVE COMPARATOR

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

Drug: Flucloxacillin Only Product in Oral Dose Form

Interventions

Flucloxacillin Only Product in Oral Dose Form 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

Control; Intervention

Placebo Only Product in Oral Dose Form 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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southampton: lead
• University of East Anglia: collaborator
• University of Nottingham: collaborator
• Norfolk and Norwich University Hospitals NHS Foundation Trust: collaborator
• University Hospital Southampton NHS Foundation Trust: collaborator

Study Sites (1)

Royal South Hants Hospital

Southampton, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Central Study Contacts

Sophie Varkonyi-Clifford

CONTACT

0 23 8059 1532; coat@soton.ac.uk

Ella Bourke

CONTACT

02381550206; coat@soton.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: October 18, 2022
• Study Start: August 29, 2023
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)