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Naproxen Versus Placebo as Adjunct Treatment of Cellulitis (NVP)

3. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

884

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Krishan Yadav, MD, MSc
  • Telefonnummer: 19489 613-798-5555
  • E-Mail: kyadav@toh.ca

Studieren Sie die Kontaktsicherung

  • Name: Gabriel Sandino-Gold, BScHK
  • Telefonnummer: 17709 613-798-5555
  • E-Mail: gsandino@ohri.ca

Studienorte

  • Kanada
    • Ontario
      • Ottawa, Ontario, Kanada, K1y 4E9
        • The Ottawa Hospital
        • Kontakt:
          • Krishan Yadav
          • Telefonnummer: 613-798-5555
          • E-Mail: kyadav@toh.ca
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Naproxen + Cephalexin
seven-day medication package of naproxen 500 mg to be taken orally twice daily plus cephalexin antibiotic 500 mg four times daily.
Arzneimittel: enteric-coated naproxen
500 mg naproxen PO BID for 7 days
Andere Namen:
  • Naproxen
  • naproxen EC
Arzneimittel: Cephalexin Tablets
500 mg PO QID for 7 days
Andere Namen:
  • Cephalexin
Aktiver Komparator: Placebo + Cephalexin
seven-day medication package of placebo to be taken orally twice daily plus cephalexin antibiotic 500 mg four times daily.
Arzneimittel: Cephalexin Tablets
500 mg PO QID for 7 days
Andere Namen:
  • Cephalexin
Arzneimittel: Placebo
Placebo tablets PO BID x 7 days

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants with Early Clinical Response Assessed by Change in Lesion Area (cm²)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Anzahl der Teilnehmer mit Medikamenteneinhaltung
Zeitfenster: 7 Tage
mit vollständiger Adhärenz, definiert als Patienten, die angeben, über einen Zeitraum von 7 Tagen alle Studienmedikamente eingenommen zu haben
7 Tage
Number of Participants with Oral antibiotic treatment failure
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Evaluated at day 8 and 30
Defined as absence of erythema, pain and fever
Evaluated at day 8 and 30
Recurrence
Zeitfenster: 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
Zeitfenster: 90 days
Visits to ED, family doctor or walk in clinic
90 days
Number of Participants with an Unplanned hospitalization for cellulitis
Zeitfenster: 90 days
within 30 and 90 days.
90 days
Use of (i) acetaminophen; (ii) opioids; and (iii) corticosteroids
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ottawa Hospital Research Institute

Mitarbeiter

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

Ermittler

  • Hauptermittler: Krishan Yadav, MD, MSc, Ottawa Hospital Research Institute

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. September 2026

Primärer Abschluss (Geschätzt)

1. Dezember 2030

Studienabschluss (Geschätzt)

1. Dezember 2031

Studienanmeldedaten

Zuerst eingereicht

18. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. Juni 2026

Zuerst gepostet (Tatsächlich)

24. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

7. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 20260315-01T

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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