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Naproxen Versus Placebo as Adjunct Treatment of Cellulitis

Study acronym: NVP
StatusNot Yet Recruiting
PhasePhase 3
Started2026-09-01
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Ottawa Hospital Research Institute

Amendment history

2026-07-03
Study Identification, Study Status, Study Description, Outcome Measures, Eligibility v1
Primary endpoint(s) modified1 entry, revised
WasNumber of Participants with Early Clinical Response
NowNumber of Participants with Early Clinical Response Assessed by Change in Lesion Area (cm²)
Eligibility criteria-51 characters
[...] to be eligible for outpatient treatment with oral cephalexin. Exclusion Criteria: These are appropriate exclusions accord [...] ility for treatment with naproxen in clinical practice, and wethe investigators believe that relatively few patients will be excluded. WeThe investigators 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-resi [...] [...]
Secondary endpoints10 entries, revised
Pain MeasurementMeasured Using the Numeric Rating Scale (0-10) NumberHealth-Related Quality of ParticipantsLife withMeasured healthUsing the EuroQol 5-relatedDimension quality5-Level of life(EQ-5D-5L)
Study description-1,307 characters
Background and Importance: Cellulitis is a common bacterial skin infection thatand isa thefrequent 9thcause most common reason for anof emergency department (ED) visitvisits in Canada. ThisStandard conditionmanagement isinvolves treatedantibiotic with antibioticstherapy; however, mostpatients peopleoften requireexperience rest and time off work due to the disabling symptoms ofsignificant pain, rednesserythema, and swelling. Cellulitis resultsthat incan high healthcare costs and negatively impactsimpair quality of life ofand affected personsproductivity. Although cellulitisThere is a bacterial [...] [...]
Study title-31 characters
Naproxen Versus Placebo as Adjunct Treatment of Cellulitis: A Randomized Controlled Trial
2026-06-18
Original filing
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.
Trial Details
NCT Number NCT07665476
Lead Sponsor Ottawa Hospital Research Institute
Collaborators: The Ottawa Hospital Academic Medical Association, l'Association Médicale Universitaire Montfort (AMUM)
Conditions Cellulitis, Skin Disease, Infectious, Infection, Skin and Soft Tissue Infections (SSTIs)
Enrollment 884 participants
Start Date 2026-09-01
Primary Completion 2030-12-01 (estimated)
Study Completion 2031-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-07