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

Information source: Swiss National Fund for Scientific Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Community-acquired Pneumonia

Intervention: Beta lactam (amoxicillin / clav. acid OR cefuroxime) (Drug); Beta-lactam (amoxicillin / clav. acid OR cefuroxime) AND macrolide (clarithromycin) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Swiss National Fund for Scientific Research

Official(s) and/or principal investigator(s):
Arnaud Perrier, MD, Principal Investigator, Affiliation: University of Geneva and University Hospital of Geneva


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.

Clinical Details

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

Primary outcome: Time to Clinical Stability (hours)

Secondary outcome:

All cause mortality

length of stay


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

HFR-Fribourg, Hôpital Cantonal, Fribourg 1708, Switzerland

Hôpitaux Universitaires de Genève, Geneva 1211, Switzerland

Hôpital Neuchâtelois - La Chaux-de-Fonds, La Chaux-de-Fonds 2300, Switzerland

Centre Hospitalier Universitaire Vaudois, Lausanne 1011, Switzerland

Stadtspital Triemli, Zürich 8063, Switzerland

Centre Hospitalier du Centre du Valais, Sion, Valais 1950, Switzerland

Additional Information

Starting date: January 2009
Last updated: April 24, 2013

Page last updated: August 23, 2015

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