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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

English 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
Applicant Perrier Arnaud
Number 120074
Funding scheme Project funding (Div. I-III)
Research institution Département Médecine interne HUG
Institution of higher education University of Geneva - GE
Main discipline Internal Medicine
Start/End 01.02.2009 - 30.04.2013
Approved amount 325'500.00
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Keywords (10)

Community-acquired pneumonia; therapy; antibiotics; CTU support; Geneva; protocol counseling; Pneumonia; combination therapy; atypical bacteria; clinical stability

Lay Summary (English)

Lead
Lay summary
Community-acquired pneumonia, that is, a lung infection acquired in an ambulatory setting, is a common disease, which impacts heavily on mortality, morbidity, health care costs and antibiotic resistance. Its global burden is expected to increase in our ageing society, as its incidence and severity are related to age and co-morbid diseases.Community-acquired pneumonia is also a highly heterogeneous disease. Its severity ranges from a mild, self-limiting illness, to a devastating infection leading to multi-organ failure and death. Many different pathogens can cause pneumonia. Prompt administration of an appropriate antibiotic is associated with lower mortality. However, the pathogen cannot be predicted by clinical means, diagnostic tests are rarely available early in the course of the disease to guide the treatment, and no pathogen is identified in 50-70 % of community-acquired pneumonias. Therefore, the initial antibiotic therapy is most often empiric.Despite a lot of previous work, there is no consensus about the best empiric antibiotic treatment. In particular, there is a long lasting controversy about the need of double vs. single antibiotic regimen to treat patients suffering from pneumonia severe enough to need hospitalization, but not in vital distress.A double regimen allows coverage of more pathogens, and possibly synergistic and anti-inflammatory actions. However, it could cause more side effects, and has more potential for selecting antibiotic-resistant bacteria.Our study aims at treating patients randomly with one or two antibiotics, which is the only mean to determine if one of these regimens is superior to the other. The main issue of interest is the time from the beginning of the treatment until the patient has improved to a point that he can be considered to be discharged from the hospital. Complications, such as death, transfer to the intensive care unit, allergic and toxic reactions, and length of hospitalization will also be studied.If the single regimen proves to be equivalent to its comparator, it can potentially allow us to spare a lot of antibiotic prescriptions, with a probable decrease in side effects, costs, and antibiotic selection pressure.A sub study will use molecular techniques (polymerase chain reactions) to try to identify new potential pathogens, which could explain why the pathogen is not identified with traditional means in at least 50% of patients.
Direct link to Lay Summary Last update: 21.02.2013

Responsible applicant and co-applicants

Employees

Collaboration

Group / person Country
Types of collaboration
Hôpital Neuchâtelois, La Chaux-de-Fonds Switzerland (Europe)
- Publication
- Research Infrastructure
CHUV - Service de médecine interne et service des urgences Switzerland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
Hôpital Fribourgeois, Médecine et maladies infectieuses Switzerland (Europe)
- Publication
- Research Infrastructure
Centre hospitalier du Valais Romand, service de médecine interne Switzerland (Europe)
- Publication
- Research Infrastructure
TriemliSpital, Zürich Switzerland (Europe)
- Publication
- Research Infrastructure

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