Naproxen Versus Placebo as Adjunct Treatment of Cellulitis

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.

Conditions

• Cellulitis
• Skin Disease, Infectious
• Infection
• Skin and Soft Tissue Infections (SSTIs)

Interventions

DRUG

enteric-coated naproxen

500 mg naproxen PO BID for 7 days

DRUG

Cephalexin Tablets

500 mg PO QID for 7 days

DRUG

Placebo

Placebo tablets PO BID x 7 days

Sponsors & Collaborators

• The Ottawa Hospital Academic Medical Association

  collaborator OTHER

• l'Association Médicale Universitaire Montfort (AMUM)

  collaborator UNKNOWN

• Ottawa Hospital Research Institute

  lead OTHER

Principal Investigators

• Krishan Yadav, MD, MSc · Ottawa Hospital Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2030-12-01

Completion

2031-12-01

Countries

• Canada

Study Locations