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

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: Recruiting

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

Overall contact:
Garin Nicolas, MD, Phone: +41 22 372 90 62, Email: Nicolas.Garin@hcuge.ch

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.

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.

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

Garin Nicolas, MD, Phone: +41 22 372 90 62, Email: Nicolas.Garin@hcuge.ch

HFR-Fribourg, Hôpital Cantonal, Fribourg 1708, Switzerland; Recruiting
Christian Chuard, MD, Phone: +41 264267482, Email: chuardc@h-fr.ch
Christian Chuard, MD, Principal Investigator

Hôpitaux Universitaires de Genève, Geneva 1211, Switzerland; Recruiting
Nicolas Garin, MD, Email: Nicolas.Garin@hcuge.ch
Arnaud Perrier, MD, Sub-Investigator
Nicolas Garin, MD, Principal Investigator
Olivier Rutschmann, Sub-Investigator
Stephan Harbarth, MD/ MS, Sub-Investigator
Thierry Rochat, MD, Sub-Investigator

Hôpital Neuchâtelois - La Chaux-de-Fonds, La Chaux-de-Fonds 2300, Switzerland; Recruiting
Daniel Genné, MD, Email: daniel.genne@ne.ch
Daniel Genné, MD, Principal Investigator
Laurent Seravalli, MD, Principal Investigator

Centre Hospitalier Universitaire Vaudois, Lausanne 1011, Switzerland; Recruiting
Olivier Lamy, MD, Email: olivier.lamy@chuv.ch
Olivier Lamy, MD, Principal Investigator
Olivier Hugli, MD, Principal Investigator

Stadtspital Triemli, Zürich 8063, Switzerland; Recruiting
Gerhard Eich, MD, Email: gerhard.eich@triemli.stzh.ch
Gerhard Eich, MD, Principal Investigator

Centre Hospitalier du Centre du Valais, Sion, Valais 1950, Switzerland; Recruiting
Pierre-Auguste Petignat, MD
Email: Pierre-Auguste.Petignat@hopitalvs.ch
Pierre-Auguste Petignat, MD, Principal Investigator

Starting date: January 2009
Last updated: July 28, 2011