Monotherapy Versus Bitherapy in Non-severe Hospitalized Community-acquired Pneumonia - Full Text View

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

This study is currently recruiting participants.

Verified by Swiss National Fund for Scientific Research, September 2009

First Received: January 6, 2009 Last Updated: September 17, 2009 History of Changes

Sponsor:	Swiss National Fund for Scientific Research
Collaborator:	University Hospital, Geneva
Information provided by:	Swiss National Fund for Scientific Research
ClinicalTrials.gov Identifier:	NCT00818610

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
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

Drug Information available for: Amoxicillin Amoxicillin sodium Cefuroxime Cefuroxime sodium Amoxicillin trihydrate Cefuroxime axetil Amoxicillin-potassium clavulanate combination Clarithromycin

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:

mortality [ Time Frame: 30 and 90 days ] [ Designated as safety issue: Yes ]
length of stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	600
Study Start Date:	January 2009
Estimated Study Completion Date:	November 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Monotherapy: Experimental	Drug: Beta lactam (amoxicillin / clav. acid OR cefuroxime) 1.2 g 4x/d OR 1.5 g 3x/d IV
Bi-therapy: Active Comparator	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

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

Contacts

Contact: Garin Nicolas, MD

+41 22 372 92 05

Nicolas.Garin@hcuge.ch

Locations

Switzerland
Hôpitaux Universitaires de Genève	Recruiting
Geneva, Switzerland, 1211
Contact: Nicolas Garin, MD Nicolas.Garin@hcuge.ch
Principal Investigator: Arnaud Perrier, MD
Sub-Investigator: Nicolas Garin, MD
Sub-Investigator: Olivier Rutschmann
Sub-Investigator: Stephan Harbarth, MD/ MS
Sub-Investigator: Thierry Rochat, MD
Centre Hospitalier Universitaire Vaudois	Recruiting
Lausanne, Switzerland, 1011
Contact: Olivier Lamy, MD olivier.lamy@chuv.ch
Principal Investigator: Olivier Lamy, MD
Principal Investigator: Olivier Hugli, MD
Hôpital Neuchâtelois - La Chaux-de-Fonds	Recruiting
La Chaux-de-Fonds, Switzerland, 2300
Contact: Daniel Genné, MD daniel.genne@ne.ch
Principal Investigator: Daniel Genné, MD
Principal Investigator: Laurent Seravalli, MD

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:	University of Geneva and University Hospital of Geneva ( Perrier, Arnaud / Professor of Medicine )
Study ID Numbers:	3200B0-120074/1
Study First Received:	January 6, 2009
Last Updated:	September 17, 2009
ClinicalTrials.gov Identifier:	NCT00818610 History of Changes
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:

Lactams
Anti-Infective Agents
Amoxicillin
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Amoxicillin-Potassium Clavulanate Combination
Pharmacologic Actions
Protein Synthesis Inhibitors
Clarithromycin

Anti-Bacterial Agents
Cefuroxime
Cefuroxime axetil
Respiratory Tract Diseases
Respiratory Tract Infections
Therapeutic Uses
Lung Diseases
Beta-Lactams
Pneumonia

ClinicalTrials.gov processed this record on November 20, 2009