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
  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:


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
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, see Learn About Clinical Studies.

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 August 28, 2014