Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Monotherapy Versus Bitherapy in Non-severe Hospitalized Community-acquired Pneumonia (BICAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00818610
Recruitment Status : Completed
First Posted : January 7, 2009
Last Update Posted : April 25, 2013
Sponsor:
Collaborator:
University Hospital, Geneva
Information provided by (Responsible Party):
Garin Nicolas, Swiss National Fund for Scientific Research

Tracking Information
First Submitted Date  ICMJE January 6, 2009
First Posted Date  ICMJE January 7, 2009
Last Update Posted Date April 25, 2013
Study Start Date  ICMJE January 2009
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2009)
Time to Clinical Stability (hours) [ Time Frame: 30 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 28, 2009)
  • All cause mortality [ Time Frame: in-hospital, at 30 and at 90 days ]
  • length of stay [ Time Frame: 30 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2009)
  • mortality [ Time Frame: 30 and 90 days ]
  • length of stay [ Time Frame: 30 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Monotherapy Versus Bitherapy in Non-severe Hospitalized Community-acquired Pneumonia
Official Title  ICMJE 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.
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Community-acquired Pneumonia
Intervention  ICMJE
  • Drug: Beta lactam (amoxicillin / clav. acid OR cefuroxime)
    1.2 g 4x/d OR 1.5 g 3x/d IV
    Other Names:
    • Augmentin
    • Zinacef
  • 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
    Other Names:
    • Augmentin
    • Zinacef
    • Klacid
Study Arms  ICMJE
  • Experimental: Monotherapy
    Intervention: Drug: Beta lactam (amoxicillin / clav. acid OR cefuroxime)
  • Active Comparator: Bi-therapy
    Intervention: Drug: Beta-lactam (amoxicillin / clav. acid OR cefuroxime) AND macrolide (clarithromycin)
Publications * Garin N, Genné D, Carballo S, Chuard C, Eich G, Hugli O, Lamy O, Nendaz M, Petignat PA, Perneger T, Rutschmann O, Seravalli L, Harbarth S, Perrier A. β-Lactam monotherapy vs β-lactam-macrolide combination treatment in moderately severe community-acquired pneumonia: a randomized noninferiority trial. JAMA Intern Med. 2014 Dec;174(12):1894-901. doi: 10.1001/jamainternmed.2014.4887.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 24, 2013)
601
Original Estimated Enrollment  ICMJE
 (submitted: January 6, 2009)
600
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00818610
Other Study ID Numbers  ICMJE 3200B0-120074/1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Garin Nicolas, Swiss National Fund for Scientific Research
Study Sponsor  ICMJE Swiss National Fund for Scientific Research
Collaborators  ICMJE University Hospital, Geneva
Investigators  ICMJE
Principal Investigator: Arnaud Perrier, MD University of Geneva and University Hospital of Geneva
PRS Account Swiss National Fund for Scientific Research
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP