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Cellulitis Optimal Antibiotic Treatment

NCT05584007 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 334

Last updated 2026-05-15

No results posted yet for this study

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

Interventions

DRUG

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

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

Sponsors & Collaborators

  • University of East Anglia

    collaborator OTHER

  • University of Nottingham

    collaborator OTHER

  • Norfolk and Norwich University Hospitals NHS Foundation Trust

    collaborator OTHER

  • University Hospital Southampton NHS Foundation Trust

    collaborator OTHER

  • University of Southampton

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-29
Primary Completion
2026-05-31
Completion
2027-07-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05584007 on ClinicalTrials.gov