Overview

Study to Proof the Clinical and Bacteriological Non-inferiority of Ampicillin/Amoxicillin Versus Moxifloxacin in Hospitalized Patients With Non-severe Community-acquired Pneumonia

Status:
Terminated
Trial end date:
2011-01-01
Target enrollment:
0
Participant gender:
All
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 pneumonia.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Ulm
Collaborator:
CAPNETZ Stiftung
Treatments:
Amoxicillin
Ampicillin
Fluoroquinolones
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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