Study to Proof the Clinical and Bacteriological Non-inferiority of Ampicillin/Amoxicillin Versus Moxifloxacin in Hospitalized Patients With Non-severe Community-acquired Pneumonia
Information source: University of Ulm
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Community Acquired Pneumonia
Intervention: Moxifloxacin (Drug); Ampicillin;Amoxicillin (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: University of Ulm Official(s) and/or principal investigator(s): Tobias Welte, Prof., Principal Investigator, Affiliation: Hannover Medical School
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.
Clinical Details
Official title: Prospective, Doubleblind, Randomized Multicenter Study to Proof the Clinical and Bacteriological Non-inferiority of Ampicillin/Amoxicillin Versus Moxifloxacin in Hospitalized Patients With Non-severe Community-acquired Pneumonia
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Proof of the clinical non inferiority by the cure rate at the treatment of a Pneumonia at the therapy end (round 3: Day 7 to 10) with a standard penicillin in a high dosage
Secondary outcome: clinical cure ratebacteriological effectiveness on patients and seed level bacteriological sensitivity into-vitro time up to the drug-switch time until the dismissal of the patients necessity of the gift of additional antibacterial drug cost reduction of the antibiotic-therapy and the complete treatment assessment of the effectiveness by the investigator
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Charité - Universitätsmedizin Berlin ,Campus Virchow-Klinikum ,Medizinische Klinik : Infektiologie u. Pneumologie, Berlin, Germany
HELIOS-Klinikum Emil von Behring ,Lungenklinik Heckeshorn, Berlin, Germany
Klinikum der Ruhr Universität , Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil, Medizinische Klinik III, Bochum, Germany
Medizinische Hochschule Hannover, Abteilung für Pneumologie, Hannover, Germany
Universitätsklinikum-Schleswig-Holstein, Campus Lübeck, Zentralklinikum, MK III, Studienzentrum Pneumologie-Infektiologie-Onkologie,, Lübeck, Germany
Brüderkrankenhaus St. Josef , Innere Abteilung, Paderborn, Germany
Diakoniekrankenhaus Rotenburg gGmbH, Lungenklinik Unterstedt , Zentrum für Pneumologie, Rotenburg, Germany
Universitätsklinikum Ulm Sektion Pneumologie/Klinik für Innere Medizin II, Ulm, Germany
Additional Information
Starting date: November 2008
Last updated: December 16, 2014
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