COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: 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. Identifier: NCT00818610
Recruitment Status : Completed
First Posted : January 7, 2009
Last Update Posted : April 25, 2013
University Hospital, Geneva
Information provided by (Responsible Party):
Garin Nicolas, Swiss National Fund for Scientific Research

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
Community-acquired Pneumonia Drug: Beta lactam (amoxicillin / clav. acid OR cefuroxime) Drug: Beta-lactam (amoxicillin / clav. acid OR cefuroxime) AND macrolide (clarithromycin) Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : January 2009
Actual Primary Completion Date : January 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

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

Primary Outcome Measures :
  1. Time to Clinical Stability (hours) [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. All cause mortality [ Time Frame: in-hospital, at 30 and at 90 days ]
  2. length of stay [ Time Frame: 30 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00818610

Layout table for location information
Centre Hospitalier du Centre du Valais
Sion, Valais, Switzerland, 1950
HFR-Fribourg, Hôpital Cantonal
Fribourg, Switzerland, 1708
Hôpitaux Universitaires de Genève
Geneva, Switzerland, 1211
Hôpital Neuchâtelois - La Chaux-de-Fonds
La Chaux-de-Fonds, Switzerland, 2300
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, 1011
Stadtspital Triemli
Zürich, Switzerland, 8063
Sponsors and Collaborators
Swiss National Fund for Scientific Research
University Hospital, Geneva
Layout table for investigator information
Principal Investigator: Arnaud Perrier, MD University of Geneva and University Hospital of Geneva
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Garin Nicolas, Associate physician, Swiss National Fund for Scientific Research Identifier: NCT00818610    
Other Study ID Numbers: 3200B0-120074/1
First Posted: January 7, 2009    Key Record Dates
Last Update Posted: April 25, 2013
Last Verified: April 2013
Keywords provided by Garin Nicolas, Swiss National Fund for Scientific Research:
Community-acquired infections
Clinical Stability
Combination therapy
Atypical bacteria
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Amoxicillin-Potassium Clavulanate Combination
Cefuroxime axetil
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
beta-Lactamase Inhibitors