Naproxen for Cellulitis

(NVP Trial)

KY
GS
Overseen ByGabriel Sandino-Gold, BScHK
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Ottawa Hospital Research Institute
Must be taking: Antibiotics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding naproxen, a common pain reliever, to antibiotics can speed up recovery for people with cellulitis. Cellulitis is a painful skin infection that causes redness and swelling. Participants will receive either naproxen with antibiotics or a placebo with antibiotics to determine which treatment is more effective. Those diagnosed with cellulitis and eligible for outpatient treatment with oral antibiotics may be suitable candidates for this study. The goal is to find a fast and effective treatment for cellulitis that reduces pain and improves recovery time. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that naproxen, a common pain reliever, is generally safe for short-term use. One study found that combining naproxen with antibiotics was safe for people with cellulitis, a skin infection. In that study, naproxen reduced swelling without causing serious side effects.

Naproxen is also used for other health issues, which supports its safety profile. However, like all similar medications, it can cause side effects, particularly with long-term use. These side effects may include stomach upset or an increased risk of heart problems, but such risks are more likely with prolonged use, not the short-term use typical for treating cellulitis.

Overall, evidence suggests that naproxen is safe for short-term use in treating cellulitis, especially when combined with antibiotics.12345

Why do researchers think this study treatment might be promising?

Naproxen is unique because it offers an anti-inflammatory approach to treating cellulitis, which is typically managed with antibiotics like cephalexin alone. Most treatments for cellulitis focus solely on targeting the bacterial infection. However, Naproxen, a nonsteroidal anti-inflammatory drug (NSAID), adds the potential to reduce inflammation and pain associated with the condition, potentially speeding up recovery. Researchers are excited about this combined approach because it could enhance patient comfort and improve outcomes more quickly than antibiotics alone.

What evidence suggests that naproxen might be an effective treatment for cellulitis?

Research has shown that taking naproxen with antibiotics might reduce swelling and speed up recovery for people with cellulitis. In this trial, one group of participants will receive naproxen and cephalexin, while another group will receive a placebo with cephalexin. Some studies have found that anti-inflammatory treatments can accelerate symptom resolution, with some patients fully recovering in just 4 to 5 days. Specifically, one study found that combining cefazolin and naproxen was more effective than using just one treatment. Although not all studies show a difference at every point in time, the potential for quicker healing and less pain makes naproxen a promising addition to standard antibiotic treatment for cellulitis.23567

Who Is on the Research Team?

KY

Krishan Yadav, MD, MSc

Principal Investigator

Ottawa Hospital Research Institute

Are You a Good Fit for This Trial?

This trial is for people diagnosed with cellulitis, a bacterial skin infection. Participants must be adults who can take oral medications and do not have conditions or allergies that would make naproxen or cephalexin unsafe for them.

Inclusion Criteria

I am an adult with cellulitis and can be treated as an outpatient with oral cephalexin.

Exclusion Criteria

I have had a stomach or intestinal ulcer or bleeding in the past year.
I have inflammatory bowel disease.
Treating physician decides IV antibiotics are required
See 18 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either naproxen or placebo in addition to oral antibiotics for 7 days

1 week
Daily medication administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days
Assessments at day 3, 8, 30, and 90

What Are the Treatments Tested in This Trial?

Interventions

  • Naproxen

Trial Overview

The study compares adding naproxen (an anti-inflammatory pain reliever) to standard antibiotic treatment (cephalexin) versus antibiotics plus a placebo. Patients are randomly assigned to one of the two groups.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Naproxen + CephalexinExperimental Treatment2 Interventions
Group II: Placebo + CephalexinActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials
585
Recruited
3,283,000+

The Ottawa Hospital Academic Medical Association

Collaborator

Trials
24
Recruited
3,000+

l'Association Médicale Universitaire Montfort (AMUM)

Collaborator

Citations

Comparison of the Efficacy of Cefazolin ...

In patients diagnosed with cellulitis, the combination therapy with cefazolin and naproxen was far more effective than the monotherapy with ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38796807/

Anti-inflammatories as adjunct treatment for cellulitis

Clinical cure was reported by three trials, and there was no difference between groups at all timepoints up to 22 days. Statistical ...

Acute cellulitis and erysipelas in adults: Treatment

While some data suggest that use of NSAIDs or corticosteroids may hasten healing among patients with cellulitis or erysipelas, these results ...

A double-blind randomized controlled trial of ibuprofen ...

Results ; Return to usual activities at day 14, 10/14 (71%), 19/20 (95%) ; Cellulitis completely resolved at day 6, 7/20 (35%), 5/19 (26%) ; Cellulitis completely ...

Naproxen Versus Placebo as Adjunct Treatment of Cellulitis

naproxen proves to be superior to placebo, this simple, low-cost intervention will speed time to recovery with less pain for patients, and may ...

Clinical Pharmacology and Cardiovascular Safety of Naproxen

This paper discusses the cardiovascular safety profile of naproxen in the context of the NSAID class. The balance of evidence suggests that cardiovascular risk ...

HIGHLIGHTS OF PRESCRIBING INFORMATION

These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after ...