Clinical trial NCT00818610: Monotherapy Versus Bitherapy in Non-severe Hospitalized 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Community-acquired Pneumonia
Keywords: Community-acquired infections
Pneumonia
Clinical Stability
Antibiotics
Combination therapy
Atypical bacteria
Lead sponsor: Swiss National Fund for Scientific Research
Sponsor class: OTHER
Collaborators: name: University Hospital, Geneva
First posted: 2009-01-07
Enrollment: 601
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Time to Clinical Stability (hours)
timeFrame: 30 days
Secondary outcomes:
measure: All cause mortality
timeFrame: in-hospital, at 30 and at 90 days
measure: length of stay
timeFrame: 30 days
Other outcomes:
Locations:
city: Sion
country: Switzerland
facility: Centre Hospitalier du Centre du Valais
state: Valais
city: Fribourg
country: Switzerland
facility: HFR-Fribourg, Hôpital Cantonal
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires de Genève
city: La Chaux-de-Fonds
country: Switzerland
facility: Hôpital Neuchâtelois - La Chaux-de-Fonds
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: Zürich
country: Switzerland
facility: Stadtspital Triemli
Study officials:
affiliation: University of Geneva and University Hospital of Geneva
name: Arnaud Perrier, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.