Naproxen Versus Placebo as Adjunct Treatment of Cellulitis

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute

About this trial

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.

Eligibility criteria

Qualifiers

adults (age ≥18 years)

diagnosed with cellulitis and

determined by the treating physician to be eligible for outpatient treatment with oral cephalexin

Disqualifiers

Age <18 years;

Patient already taking oral antibiotics or NSAIDs;

Treating physician decides IV antibiotics are required;

Skin abscess requiring incision and drainage;

Trial design

Treatments tested in this trial

  • enteric-coated naproxen
  • Cephalexin Tablets
  • Placebo

Treatment groups

884 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Ottawa Hospital Research Institute

Lead sponsor

The Ottawa Hospital Academic Medical Association

Collaborator

l'Association Médicale Universitaire Montfort (AMUM)

Collaborator