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Naproxen Versus Placebo as Adjunct Treatment of Cellulitis (NVP)

3 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

884

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Krishan Yadav, MD, MSc
  • Numéro de téléphone: 19489 613-798-5555
  • E-mail: kyadav@toh.ca

Sauvegarde des contacts de l'étude

  • Nom: Gabriel Sandino-Gold, BScHK
  • Numéro de téléphone: 17709 613-798-5555
  • E-mail: gsandino@ohri.ca

Lieux d'étude

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4E9
        • The Ottawa Hospital
        • Contact:
          • Krishan Yadav
          • Numéro de téléphone: 613-798-5555
          • E-mail: kyadav@toh.ca
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Naproxen + Cephalexin
seven-day medication package of naproxen 500 mg to be taken orally twice daily plus cephalexin antibiotic 500 mg four times daily.
Médicament: enteric-coated naproxen
500 mg naproxen PO BID for 7 days
Autres noms:
  • naproxène
  • naproxen EC
Médicament: Cephalexin Tablets
500 mg PO QID for 7 days
Autres noms:
  • Céphalexine
Comparateur actif: Placebo + Cephalexin
seven-day medication package of placebo to be taken orally twice daily plus cephalexin antibiotic 500 mg four times daily.
Médicament: Cephalexin Tablets
500 mg PO QID for 7 days
Autres noms:
  • Céphalexine
Médicament: Placebo
Placebo tablets PO BID x 7 days

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of Participants with Early Clinical Response Assessed by Change in Lesion Area (cm²)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Nombre de participants avec adhésion aux médicaments
Délai: 7 jours
avec une observance totale définie comme les patients qui déclarent avoir pris tous les médicaments à l'étude pendant 7 jours
7 jours
Number of Participants with Oral antibiotic treatment failure
Délai: 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
Délai: 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
Délai: Evaluated at day 8 and 30
Defined as absence of erythema, pain and fever
Evaluated at day 8 and 30
Recurrence
Délai: 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
Délai: 90 days
Visits to ED, family doctor or walk in clinic
90 days
Number of Participants with an Unplanned hospitalization for cellulitis
Délai: 90 days
within 30 and 90 days.
90 days
Use of (i) acetaminophen; (ii) opioids; and (iii) corticosteroids
Délai: 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)
Délai: 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)
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Ottawa Hospital Research Institute

Collaborateurs

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

Les enquêteurs

  • Chercheur principal: Krishan Yadav, MD, MSc, Ottawa Hospital Research Institute

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 septembre 2026

Achèvement primaire (Estimé)

1 décembre 2030

Achèvement de l'étude (Estimé)

1 décembre 2031

Dates d'inscription aux études

Première soumission

18 juin 2026

Première soumission répondant aux critères de contrôle qualité

18 juin 2026

Première publication (Réel)

24 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

7 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 20260315-01T

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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