Monotherapy Versus Bitherapy in Non-severe Hospitalized Community-acquired Pneumonia

Overview

The purpose of this study is to determine whether a monotherapy with a Beta-Lactam is not inferior to an association of a Beta-Lactam and a macrolide in treating adult patients with community-acquired pneumonia.

Full Title of Study: “Beta-lactam Monotherapy Versus Beta-lactam – Macrolide Association as Empiric Antibiotherapy Strategies in Non-severe Hospitalized Community-acquired Pneumonia: a Randomized, Non-inferiority, Open Trial.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: January 2013

Interventions

  • Drug: Beta lactam (amoxicillin / clav. acid OR cefuroxime)
    • 1.2 g 4x/d OR 1.5 g 3x/d IV
  • Drug: Beta-lactam (amoxicillin / clav. acid OR cefuroxime) AND macrolide (clarithromycin)
    • 1.2 g 4x/d OR 1.5 g 3x/d IV AND 0.5 g 2x/d IV/PO

Arms, Groups and Cohorts

  • Experimental: Monotherapy
  • Active Comparator: Bi-therapy

Clinical Trial Outcome Measures

Primary Measures

  • Time to Clinical Stability (hours)
    • Time Frame: 30 days

Secondary Measures

  • All cause mortality
    • Time Frame: in-hospital, at 30 and at 90 days
  • length of stay
    • Time Frame: 30 days

Participating in This Clinical Trial

Inclusion Criteria

  • Age >=18 years
  • New infiltrate on chest X-ray, unexplained by another disease process
  • Presence of at least two of the following findings suggestive of pneumonia: fever or hypothermia, new or increasing cough, sputum production, pleuritic chest pain, tachypnea, dyspnea or focal signs on chest examination
  • Need for hospitalization as defined by the emergency physician in charge of the patient

Exclusion Criteria

  • Allergy to one of the study drugs
  • Pregnancy
  • Severe immunosuppression
  • Recent (<14 d) hospitalization, or currently hospitalized since > 48 hours
  • Residency in a nursing home
  • Previous use of more than 24 hours of any antibiotic
  • Severe community-acquired pneumonia

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Swiss National Fund for Scientific Research
  • Collaborator
    • University Hospital, Geneva
  • Provider of Information About this Clinical Study
    • Principal Investigator: Garin Nicolas, Associate physician – Swiss National Fund for Scientific Research
  • Overall Official(s)
    • Arnaud Perrier, MD, Principal Investigator, University of Geneva and University Hospital of Geneva

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