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New treatment option for Cellulitis of Leg
Official title Cellulitis Optimal Antibiotic Treatment
ClinicalTrials.gov ID: NCT05584007
What this study is testing
What is Flucloxacillin Only Product in Oral Dose Form?
Flucloxacillin Only Product in Oral Dose Form is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for cellulitis of leg.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Pain rated as 3/10 or higher on a numerical rating scale (0-10) at baseline assessment
- Be willing to be assigned by chance to either trial arm (5-day or 7-day treatment)
- Able to complete trial procedures in the English language.
You likely can't join 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
See the full eligibility 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 assigned by chance to either trial arm (5-day or 7-day treatment)
- Able to complete trial procedures in the English language.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Southampton, United Kingdom
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Southampton, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.