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

This study has been completed.
Sponsor:
Collaborator:
University Hospital, Geneva
Information provided by (Responsible Party):
Garin Nicolas, Swiss National Fund for Scientific Research
ClinicalTrials.gov Identifier:
NCT00818610
First received: January 6, 2009
Last updated: April 24, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Further study details as provided by Swiss National Fund for Scientific Research:

Primary Outcome Measures:
  • Time to Clinical Stability (hours) [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All cause mortality [ Time Frame: in-hospital, at 30 and at 90 days ] [ Designated as safety issue: Yes ]
  • length of stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 601
Study Start Date: January 2009
Study Completion Date: April 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00818610

Locations
Switzerland
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
Investigators
Principal Investigator: Arnaud Perrier, MD University of Geneva and University Hospital of Geneva
  More Information

No publications provided

Responsible Party: Garin Nicolas, Associate physician, Swiss National Fund for Scientific Research
ClinicalTrials.gov Identifier: NCT00818610     History of Changes
Other Study ID Numbers: 3200B0-120074/1
Study First Received: January 6, 2009
Last Updated: April 24, 2013
Health Authority: Switzerland: Swissmedic
Switzerland: Ethikkommission

Keywords provided by Swiss National Fund for Scientific Research:
Community-acquired infections
Pneumonia
Clinical Stability
 Antibiotics
Combination therapy
Atypical bacteria

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Amoxicillin
Cefuroxime
Cefuroxime axetil
Lactams
Amoxicillin-Potassium Clavulanate Combination
 Clarithromycin
Beta-Lactams
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013