Status:
TERMINATED
Study to Proof the Clinical and Bacteriological Non-inferiority of Ampicillin/Amoxicillin Versus Moxifloxacin in Hospitalized Patients With Non-severe Community-acquired Pneumonia
Lead Sponsor:
University of Ulm
Collaborating Sponsors:
CAPNETZ Stiftung
Conditions:
Community Acquired Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to prove the clinical and bacteriological non-inferiority of ampicillin/amoxicillin versus moxifloxacin in hospitalized patients with non-severe community-acquired pneumon...
Eligibility Criteria
Inclusion
- Men or women older than 18 years with signed informed consent
- Women in a childbearing age with sufficient conception protection or if necessary negative pregnancy test
- Infiltrates appeared newly in the x-ray thorax
- Breath-conditioned chest pain
- At least two of the following clinical symptoms of a pneumonia:
- cough which is newly appeared or increasing,
- dyspnea
- mucopurulent or purulent sputum,
- fever (body temperature \>= 37.8 degrees Celsius auricalary and/or \>= 38,3°C rectal), positive auscultation
- Negative legionella antigen test in the urine
- CRB-65-Index \< 3
Exclusion
- Hospitalization within the last 28 days (except for the last 72 h)
- Participation in another therapy study within the last 4 weeks with studies admission
- intake of an antibiotic longer than 24 hrs within the last 72 hours before studies admission
- Patients in the pregnancy and nursing phase
- Existence of contraindications opposite the examining preparations or other B-Lactam antibiotics or fluorochinolons
- Patients with a CURB-Index \>= 3
- Patients with suspicion of retrostenotic Pneumonia because of bronchial obstruction
- Patients with suspicion of nosocomial Pneumonia
- Patients with an infection by a known or suspected resistant pathogene
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT00887276
Start Date
November 1 2008
End Date
January 1 2011
Last Update
December 17 2014
Active Locations (8)
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1
Charité - Universitätsmedizin Berlin ,Campus Virchow-Klinikum ,Medizinische Klinik : Infektiologie u. Pneumologie
Berlin, Germany
2
HELIOS-Klinikum Emil von Behring ,Lungenklinik Heckeshorn
Berlin, Germany
3
Klinikum der Ruhr Universität , Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil, Medizinische Klinik III
Bochum, Germany
4
Medizinische Hochschule Hannover, Abteilung für Pneumologie
Hanover, Germany