Monotherapy Versus Bitherapy in Non-severe Hospitalized Community-acquired Pneumonia

Community-acquired Pneumonia Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00818610
• Other study ID #: 3200B0-120074/1
• Status: Completed
• Phase: Phase 4
• First received: January 6, 2009
• Last updated: April 24, 2013
• Start date: January 2009
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: Swiss National Fund for Scientific Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: SwissmedicSwitzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 601
• Est. completion date: April 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Pneumonia

Intervention

Drug:
• Beta lactam (amoxicillin / clav. acid OR cefuroxime)
1.2 g 4x/d OR 1.5 g 3x/d IV
• 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

Locations

Country	Name	City	State
Switzerland	HFR-Fribourg, Hôpital Cantonal	Fribourg
Switzerland	Hôpitaux Universitaires de Genève	Geneva
Switzerland	Hôpital Neuchâtelois - La Chaux-de-Fonds	La Chaux-de-Fonds
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
Switzerland	Centre Hospitalier du Centre du Valais	Sion	Valais
Switzerland	Stadtspital Triemli	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
Swiss National Fund for Scientific Research	University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Clinical Stability (hours)		30 days	No
Secondary	All cause mortality		in-hospital, at 30 and at 90 days	Yes
Secondary	length of stay		30 days	No