Monotherapy Versus Bitherapy in Non-severe Hospitalized Community-acquired Pneumonia (BICAP)
Primary Purpose
Community-acquired Pneumonia
Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Beta lactam (amoxicillin / clav. acid OR cefuroxime)
Beta-lactam (amoxicillin / clav. acid OR cefuroxime) AND macrolide (clarithromycin)
Sponsored by
About this trial
This is an interventional treatment trial for Community-acquired Pneumonia focused on measuring Community-acquired infections, Pneumonia, Clinical Stability, Antibiotics, Combination therapy, Atypical bacteria
Eligibility 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
Sites / Locations
- Centre Hospitalier du Centre du Valais
- HFR-Fribourg, Hôpital Cantonal
- Hôpitaux Universitaires de Genève
- Hôpital Neuchâtelois - La Chaux-de-Fonds
- Centre Hospitalier Universitaire Vaudois
- Stadtspital Triemli
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Monotherapy
Bi-therapy
Arm Description
Outcomes
Primary Outcome Measures
Time to Clinical Stability (hours)
Secondary Outcome Measures
All cause mortality
length of stay
Full Information
NCT ID
NCT00818610
First Posted
January 6, 2009
Last Updated
April 24, 2013
Sponsor
Swiss National Fund for Scientific Research
Collaborators
University Hospital, Geneva
1. Study Identification
Unique Protocol Identification Number
NCT00818610
Brief Title
Monotherapy Versus Bitherapy in Non-severe Hospitalized Community-acquired Pneumonia
Acronym
BICAP
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 Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Swiss National Fund for Scientific Research
Collaborators
University Hospital, Geneva
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-acquired Pneumonia
Keywords
Community-acquired infections, Pneumonia, Clinical Stability, Antibiotics, Combination therapy, Atypical bacteria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
601 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Monotherapy
Arm Type
Experimental
Arm Title
Bi-therapy
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Beta lactam (amoxicillin / clav. acid OR cefuroxime)
Other Intervention Name(s)
Augmentin, Zinacef
Intervention Description
1.2 g 4x/d OR 1.5 g 3x/d IV
Intervention Type
Drug
Intervention Name(s)
Beta-lactam (amoxicillin / clav. acid OR cefuroxime) AND macrolide (clarithromycin)
Other Intervention Name(s)
Augmentin, Zinacef, Klacid
Intervention Description
1.2 g 4x/d OR 1.5 g 3x/d IV AND 0.5 g 2x/d IV/PO
Primary Outcome Measure Information:
Title
Time to Clinical Stability (hours)
Time Frame
30 days
Secondary Outcome Measure Information:
Title
All cause mortality
Time Frame
in-hospital, at 30 and at 90 days
Title
length of stay
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaud Perrier, MD
Organizational Affiliation
University of Geneva and University Hospital of Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier du Centre du Valais
City
Sion
State/Province
Valais
ZIP/Postal Code
1950
Country
Switzerland
Facility Name
HFR-Fribourg, Hôpital Cantonal
City
Fribourg
ZIP/Postal Code
1708
Country
Switzerland
Facility Name
Hôpitaux Universitaires de Genève
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Hôpital Neuchâtelois - La Chaux-de-Fonds
City
La Chaux-de-Fonds
ZIP/Postal Code
2300
Country
Switzerland
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Stadtspital Triemli
City
Zürich
ZIP/Postal Code
8063
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
35505308
Citation
Chauffard A, Bridevaux PO, Carballo S, Prendki V, Reny JL, Stirnemann J, Garin N. Accuracy of a score predicting the presence of an atypical pathogen in hospitalized patients with moderately severe community-acquired pneumonia. BMC Infect Dis. 2022 May 3;22(1):424. doi: 10.1186/s12879-022-07423-1.
Results Reference
derived
PubMed Identifier
25286173
Citation
Garin N, Genne D, Carballo S, Chuard C, Eich G, Hugli O, Lamy O, Nendaz M, Petignat PA, Perneger T, Rutschmann O, Seravalli L, Harbarth S, Perrier A. beta-Lactam monotherapy vs beta-lactam-macrolide combination treatment in moderately severe community-acquired pneumonia: a randomized noninferiority trial. JAMA Intern Med. 2014 Dec;174(12):1894-901. doi: 10.1001/jamainternmed.2014.4887.
Results Reference
derived
Learn more about this trial
Monotherapy Versus Bitherapy in Non-severe Hospitalized Community-acquired Pneumonia
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