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Naproxen Versus Placebo as Adjunct Treatment of Cellulitis

ConditionsCellulitisSkin Disease, InfectiousInfectionSkin and Soft Tissue Infections (SSTIs)
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • enteric-coated naproxen

    Drug

    500 mg naproxen PO BID for 7 days

  • Cephalexin Tablets

    Drug

    500 mg PO QID for 7 days

  • Placebo

    Drug

    Placebo tablets PO BID x 7 days

Treatment groups

884 Participants
are divided into 2 treatment groups
Group A: Naproxen + CephalexinExperimental treatment 2 interventions
Group B: Placebo + CephalexinActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Number of Participants with Early Clinical Response Assessed by Change in Lesion Area (cm²)

Early clinical response is defined as a reduction in lesion size (area of erythema) of at least 20% compared to baseline within 72 hours. Lesion size will be assessed by measuring the area of erythema in square centimeters (cm²). Linear dimensions of the lesion will be obtained using a disposable tape measure.

Time frame
within 72 hours

Secondary outcomes

1

Number of Participants with Oral antibiotic treatment failure

Defined as a change in antibiotic (change in class of oral antibiotic or step up to IV therapy) between 3-7 days due to worsening infection. Criteria for worsening infection: (1) New fever (temperature ≥38.0ºC) or persistent fever at follow-up; (2) Increasing area of erythema (in cm2) ≥20% from baseline; or (3) Increasing pain ≥2 points from baseline (using the Numeric Rating Scale).

Time frame
between 3-7 days
2

Pain Measured Using the Numeric Rating Scale (0-10)

Pain will be assessed using the Numeric Rating Scale (NRS), an 11-point scale ranging from 0 to 10. On the Numeric Rating Scale, 0 represents no pain and 10 represents the worst possible pain. Higher scores indicate worse pain.

Time frame
Evaluated at day 0, 3, 8 and 30
3

Number of Participants with an Antibiotic switch

Defined as an unplanned antibiotic change (change in class of oral antibiotic or step up to IV therapy) within 7 days that did not meet worsening infection criteria and treatment failure

Time frame
Within 7 days
4

Number of Participants with Clinical Cure

Defined as absence of erythema, pain and fever

Time frame
Evaluated at day 8 and 30

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ottawa Hospital Research Institute

Lead sponsor

The Ottawa Hospital Academic Medical Association

Collaborator

l'Association Médicale Universitaire Montfort (AMUM)

Collaborator

Source ClinicalTrials.gov

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