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

Sponsor
Swiss National Fund for Scientific Research (Other)
Overall Status
Completed
CT.gov ID
NCT00818610
Collaborator
University Hospital, Geneva (Other)
601
Enrollment
6
Locations
2
Arms
51
Duration (Months)
100.2
Patients Per Site
2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Beta lactam (amoxicillin / clav. acid OR cefuroxime)
  • Drug: Beta-lactam (amoxicillin / clav. acid OR cefuroxime) AND macrolide (clarithromycin)
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
601 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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 Start Date :
Jan 1, 2009
Actual Primary Completion Date :
Jan 1, 2013
Actual Study Completion Date :
Apr 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Monotherapy

Drug: Beta lactam (amoxicillin / clav. acid OR cefuroxime)
1.2 g 4x/d OR 1.5 g 3x/d IV
Other Names:
  • Augmentin
  • Zinacef

    		•
    Active Comparator: Bi-therapy

    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time to Clinical Stability (hours) [30 days]

    Secondary Outcome Measures

    1. All cause mortality [in-hospital, at 30 and at 90 days]

    2. length of stay [30 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre Hospitalier du Centre du Valais Sion Valais Switzerland 1950
    2 HFR-Fribourg, Hôpital Cantonal Fribourg Switzerland 1708
    3 Hôpitaux Universitaires de Genève Geneva Switzerland 1211
    4 Hôpital Neuchâtelois - La Chaux-de-Fonds La Chaux-de-Fonds Switzerland 2300
    5 Centre Hospitalier Universitaire Vaudois Lausanne Switzerland 1011
    6 Stadtspital Triemli Zürich Switzerland 8063

    Sponsors and Collaborators

    • Swiss National Fund for Scientific Research
    • University Hospital, Geneva

    Investigators

    • Principal Investigator: Arnaud Perrier, MD, University of Geneva and University Hospital of Geneva

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Garin Nicolas, Associate physician, Swiss National Fund for Scientific Research
    ClinicalTrials.gov Identifier:
    NCT00818610
    Other Study ID Numbers:
    • 3200B0-120074/1
    First Posted:
    Jan 7, 2009
    Last Update Posted:
    Apr 25, 2013
    Last Verified:
    Apr 1, 2013
    Keywords provided by Garin Nicolas, Associate physician, Swiss National Fund for Scientific Research
    Community-acquired infections
    Pneumonia
    Clinical Stability
    Antibiotics
    Combination therapy
    Atypical bacteria
    Additional relevant MeSH terms:
    Pneumonia
    Amoxicillin
    Clarithromycin
    Amoxicillin-Potassium Clavulanate Combination
    Cefuroxime
    Cefuroxime axetil
    Lactams
    beta-Lactams

    Study Results

    No Results Posted as of Apr 25, 2013