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Naproxen Versus Placebo as Adjunct Treatment of Cellulitis (NVP)

3 luglio 2026 aggiornato da: Ottawa Hospital Research Institute

Naproxen Versus Placebo as Adjunct Treatment of Cellulitis: A Randomized Controlled 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Cellulitis is a common bacterial skin infection and a frequent cause of emergency department visits in Canada. Standard management involves antibiotic therapy; however, patients often experience significant pain, erythema, and swelling that can impair quality of life and productivity. There is increasing evidence that inflammation contributes to these symptoms, suggesting that adjunct anti-inflammatory therapy may improve recovery.

Non-steroidal anti-inflammatory drugs (NSAIDs), such as naproxen, may reduce inflammation and improve symptom resolution when used alongside antibiotics. Prior randomized trials and meta-analyses have suggested a potential benefit in early clinical response; however, these studies were limited by small sample sizes and methodological constraints. As a result, there remains uncertainty regarding the effectiveness and safety of NSAIDs as adjunct therapy for cellulitis.

This study is a multicentre, double-blind, randomized controlled trial designed to evaluate the impact of adjunct naproxen on clinical outcomes in adult patients with cellulitis receiving standard antibiotic therapy. Participants will be randomly assigned in a 1:1 ratio to receive either naproxen or placebo in addition to oral antibiotics for 7 days. The trial will be conducted at multiple tertiary care emergency departments in Canada.

Participants will be followed longitudinally with assessments at prespecified time points to evaluate clinical response, patient-reported outcomes, healthcare utilization, and safety. Data will be collected through a combination of in-person, virtual, and telephone follow-up assessments.

The study is powered to detect a clinically meaningful difference in early response between treatment groups. Analyses will be conducted using an intention-to-treat approach, with regression-based methods used to compare outcomes between groups.

Findings from this study are expected to provide high-quality evidence regarding the role of NSAIDs as adjunct therapy for cellulitis and may inform future clinical practice guidelines and decision-making in emergency and outpatient care settings.

Tipo di studio

Interventistico

Iscrizione (Stimato)

884

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Krishan Yadav, MD, MSc
  • Numero di telefono: 19489 613-798-5555
  • Email: kyadav@toh.ca

Backup dei contatti dello studio

  • Nome: Gabriel Sandino-Gold, BScHK
  • Numero di telefono: 17709 613-798-5555
  • Email: gsandino@ohri.ca

Luoghi di studio

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1y 4E9
        • The Ottawa Hospital
        • Contatto:
          • Krishan Yadav
          • Numero di telefono: 613-798-5555
          • Email: kyadav@toh.ca
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • adults (age ≥18 years)
  • diagnosed with cellulitis and
  • determined by the treating physician to be eligible for outpatient treatment with oral cephalexin

Exclusion Criteria:

These are appropriate exclusions according to eligibility for treatment with naproxen in clinical practice, and the investigators believe that relatively few patients will be excluded.

The investigators will exclude participants for any of the following reasons:

  1. Age <18 years;
  2. Patient already taking oral antibiotics or NSAIDs;
  3. Treating physician decides IV antibiotics are required;
  4. Skin abscess requiring incision and drainage;
  5. Known prior skin or soft tissue infection secondary to methicillin-resistant Staphylococcus aureus (MRSA);
  6. Cellulitis secondary to a human or animal bite;
  7. Penetrating wound or water exposure resulting in cellulitis;
  8. Surgical site infection;
  9. Pregnancy or breastfeeding;
  10. Prior gastric bypass surgery;
  11. Patients on dual antiplatelet therapy;
  12. Patients on warfarin, low molecular weight heparin, or direct oral anticoagulant therapy;
  13. Severe uncontrolled heart failure, or coronary artery bypass grafting (CABG) surgery within 14 days prior to the index visit, or planned CABG surgery within 21 days following the index visit.;
  14. History of gastric/duodenal ulcer or gastrointestinal bleeding in the past 12 months;
  15. Known kidney impairment with an estimated glomerular filtration rate <30 mL/min documented on the electronic health record at any time within the past three months;
  16. Known hyperkalemia documented on the electronic health record at any time within the past three months;
  17. Liver cirrhosis;
  18. Inflammatory bowel disease;
  19. History of asthma, urticaria or allergic reactions after taking NSAIDs or aspirin;
  20. Allergy to cephalosporins or history of anaphylaxis to penicillin; (u) Inability to provide informed consent.

Exclusion criteria (i) through (s) are known contraindications to NSAIDs.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Naproxen + Cephalexin
seven-day medication package of naproxen 500 mg to be taken orally twice daily plus cephalexin antibiotic 500 mg four times daily.
Droga: enteric-coated naproxen
500 mg naproxen PO BID for 7 days
Altri nomi:
  • naprossene
  • naproxen EC
Droga: Cephalexin Tablets
500 mg PO QID for 7 days
Altri nomi:
  • Cefalexina
Comparatore attivo: Placebo + Cephalexin
seven-day medication package of placebo to be taken orally twice daily plus cephalexin antibiotic 500 mg four times daily.
Droga: Cephalexin Tablets
500 mg PO QID for 7 days
Altri nomi:
  • Cefalexina
Droga: Placebo
Placebo tablets PO BID x 7 days

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants with Early Clinical Response Assessed by Change in Lesion Area (cm²)
Lasso di tempo: within 72 hours

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.
within 72 hours

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Numero di partecipanti con aderenza ai farmaci
Lasso di tempo: 7 giorni
con piena aderenza definita come pazienti che riferiscono di aver assunto tutti i farmaci in studio per 7 giorni
7 giorni
Number of Participants with Oral antibiotic treatment failure
Lasso di tempo: between 3-7 days
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).
between 3-7 days
Number of Participants with an Antibiotic switch
Lasso di tempo: Within 7 days
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
Within 7 days
Number of Participants with Clinical Cure
Lasso di tempo: Evaluated at day 8 and 30
Defined as absence of erythema, pain and fever
Evaluated at day 8 and 30
Recurrence
Lasso di tempo: Evaluated at day 90
Number of patients that had a recurrence of infection at day 90, defined as development of a new skin and soft tissue infection (cellulitis or skin abscess) at the same or different anatomic site
Evaluated at day 90
Number of participants with unplanned visits to a healthcare provider for cellulitis
Lasso di tempo: 90 days
Visits to ED, family doctor or walk in clinic
90 days
Number of Participants with an Unplanned hospitalization for cellulitis
Lasso di tempo: 90 days
within 30 and 90 days.
90 days
Use of (i) acetaminophen; (ii) opioids; and (iii) corticosteroids
Lasso di tempo: Evaluated at day 3, 8 and 30.
Reporting if there is use of acetaminophen, opioids or corticosteroids during the study period.
Evaluated at day 3, 8 and 30.
Pain Measured Using the Numeric Rating Scale (0-10)
Lasso di tempo: Evaluated at day 0, 3, 8 and 30

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.
Evaluated at day 0, 3, 8 and 30
Health-Related Quality of Life Measured Using the EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Lasso di tempo: 90 days

Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) instrument.

The EQ-5D-5L descriptive system includes five domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with five levels of severity ( 1- no problems, 2 - slight problems, 3 - moderate problems, 4 - severe problems and 5 - extreme problems). A lower score indicates a better outcome.

The instrument also includes a visual analogue scale (EQ-VAS) ranging from 0 (worst imaginable health) to 100 (best imaginable health), with higher scores indicating better self-rated health.
90 days

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Ottawa Hospital Research Institute

Collaboratori

The Ottawa Hospital Academic Medical Association
l'Association Médicale Universitaire Montfort (AMUM)

Investigatori

  • Investigatore principale: Krishan Yadav, MD, MSc, Ottawa Hospital Research Institute

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 dicembre 2030

Completamento dello studio (Stimato)

1 dicembre 2031

Date di iscrizione allo studio

Primo inviato

18 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

18 giugno 2026

Primo Inserito (Effettivo)

24 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 20260315-01T

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

IPD requests can be submitted to the Investigator and will be reviewed on a case by case basis.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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