Could a common painkiller speed up cellulitis recovery?
NCT ID NCT07665476
First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times
Summary
Cellulitis is a painful bacterial skin infection. This study tests whether adding naproxen (an anti-inflammatory drug) to standard antibiotics helps reduce redness and pain faster than antibiotics alone. About 884 adults with cellulitis will take either naproxen or a placebo for 7 days, and doctors will check if the infection area shrinks by at least 20% after 72 hours.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- naproxen
- What this could lead to
- If it works, adding naproxen to antibiotics could speed up recovery, reduce pain, and lower treatment failure for cellulitis patients.
- What could go wrong
- This is a large trial, but earlier studies were too small to confirm benefit. Naproxen may not help, and like all NSAIDs, it carries risks like stomach irritation or kidney issues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 884 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 the investigators believe that relatively few patients will be excluded. The investigators will exclude participants for any of the following reasons: 1. Age \<18 years; 2. Patient already taking oral antibiotics or NSAIDs; 3. Treating physician decides IV antibiotics are required; 4. Skin abscess requiring incision and drainage; 5. Known prior skin or soft tissue infection secondary to methicillin-resistant Staphylococcus aureus (MRSA); 6. Cellulitis secondary to a human or animal bite; 7. Penetrating wound or water exposure resulting in cellulitis; 8. Surgical site infection; 9. Pregnancy or breastfeeding; 10. Prior gastric bypass surgery; 11. Patients on dual antiplatelet therapy; 12. Patients on warfarin, low molecular weight heparin, or direct oral anticoagulant therapy; 13. 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.; 14. History of gastric/duodenal ulcer or gastrointestinal bleeding in the past 12 months; 15. Known kidney impairment with an estimated glomerular filtration rate \<30 mL/min documented on the electronic health record at any time within the past three months; 16. Known hyperkalemia documented on the electronic health record at any time within the past three months; 17. Liver cirrhosis; 18. Inflammatory bowel disease; 19. History of asthma, urticaria or allergic reactions after taking NSAIDs or aspirin; 20. Allergy to cephalosporins or history of anaphylaxis to penicillin; (u) Inability to provide informed consent. Exclusion criteria (i) through (s) are known contraindications to NSAIDs.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Ottawa Hospital
Ottawa, Ontario, K1y 4E9, Canada
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