Naproxen Versus Placebo as Adjunct Treatment of Cellulitis: A Randomized Controlled Trial (NCT07665476) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Naproxen Versus Placebo as Adjunct Treatment of Cellulitis: A Randomized Controlled Trial
Canada884 participantsStarted 2026-09-01
Plain-language summary
Cellulitis is a painful bacterial skin infection commonly seen in Canadian emergency departments. Cellulitis has a negative impact on patients' quality of life and productivity. While this is a bacterial infection, there is evidence inflammation also contributes to the disabling symptoms of pain, redness and swelling. Some studies have suggested that a nonsteroidal anti-inflammatory drug (NSAID) such as naproxen in addition to antibiotics may control inflammation and speed recovery. However, these studies have had too few patients to tell if there is a true benefit.
The investigators are proposing a randomized controlled trial of patients with cellulitis to compare oral naproxen (500 mg twice daily) plus oral antibiotics versus placebo plus oral antibiotics. The investigators will compare the proportion of patients who have an early clinical response (reduction in area of redness ≥20% at 72 hours), cure, treatment failure, adverse events, and hospital admission.
If naproxen proves to be superior to placebo, this simple, low-cost intervention will speed time to recovery with less pain for patients, and may potentially reduce treatment failure and time missed from activities. The results of this trial will help inform future cellulitis treatment guidelines.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* adults (age ≥18 years) diagnosed with cellulitis and determined by the treating physician to be eligible for outpatient treatment with oral cephalexin.
Exclusion Criteria:
* These are appropriate exclusions according to eligibility for treatment with naproxen in clinical practice, and we believe that relatively few patients will be excluded. We will exclude participants for any of the following reasons: (a) Age \<18 years; (b) Patient already taking oral antibiotics or NSAIDs; (c) Treating physician decides IV antibiotics are required; (d) Skin abscess requiring incision and drainage; (e) Known prior skin or soft tissue infection secondary to methicillin-resistant Staphylococcus aureus (MRSA); (f) Cellulitis secondary to a human or animal bite; (g) Penetrating wound or water exposure resulting in cellulitis; (h) Surgical site infection; (i) Pregnancy or breastfeeding; (j) Prior gastric bypass surgery; (k) Patients on dual antiplatelet therapy; (l) Patients on warfarin, low molecular weight heparin, or direct oral anticoagulant therapy; (m) Severe uncontrolled heart failure, or coronary artery bypass grafting (CABG) surgery within 14 days prior to the index visit, or planned CABG surgery within 21 days following the index visit.; (n) History of gastric/duodenal ulcer or gastrointestinal bleeding in the past 12 months; (o) Known kidney impairment with an estimated glomerular filtration rate \<30 mL/min documented on the electronic health record at any t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with Early Clinical Response