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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 November 27, 2014
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Community Acquired Pneumonia

Intervention: Moxifloxacin (Drug); Ampicillin;Amoxicillin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Ulm

Official(s) and/or principal investigator(s):
Tobias Welte, Prof., Principal Investigator, Affiliation: Hannover Medical School

Overall contact:
Grit Barten, Phone: +49- (511) -532-4434, Email: barten.grit@mh-hannover.de

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 rate

bacteriological 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

Grit Barten, Phone: +49- (511) -532-4434, Email: barten.grit@mh-hannover.de

Charité - Universitätsmedizin Berlin ,Campus Virchow-Klinikum ,Medizinische Klinik : Infektiologie u. Pneumologie, Berlin, Germany; Recruiting

HELIOS-Klinikum Emil von Behring ,Lungenklinik Heckeshorn, Berlin, Germany; Recruiting

Klinikum der Ruhr Universität , Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil, Medizinische Klinik III, Bochum, Germany; Recruiting

Medizinische Hochschule Hannover, Abteilung für Pneumologie, Hannover, Germany; Recruiting

Universitätsklinikum-Schleswig-Holstein, Campus Lübeck, Zentralklinikum, MK III, Studienzentrum Pneumologie-Infektiologie-Onkologie,, Lübeck, Germany; Recruiting

Brüderkrankenhaus St. Josef , Innere Abteilung, Paderborn, Germany; Recruiting

Diakoniekrankenhaus Rotenburg gGmbH, Lungenklinik Unterstedt , Zentrum für Pneumologie, Rotenburg, Germany; Recruiting

Universitätsklinikum Ulm Sektion Pneumologie/Klinik für Innere Medizin II, Ulm, Germany; Recruiting

Additional Information

Starting date: November 2008
Last updated: January 11, 2010

Page last updated: November 27, 2014

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