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

Phase 4

Terminated

• Conditions: Community Acquired Pneumonia
• Interventions: Drug: Ampicillin;Amoxicillin; Drug: Moxifloxacin

• Registration Number: NCT00887276
• Lead Sponsor: University of Ulm

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 pneumonia.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-04-22
• Study First Submitted QC: 2009-04-22
• Study First Posted: 2009-04-23
• Status Verified: 2010-01
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Last Update Submitted: 2014-12-16
• Last Update Posted: 2014-12-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 290

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ampicillin; Amoxicillin	Ampicillin;Amoxicillin	-
Moxifloxacin	Moxifloxacin	-

Primary Outcome Measures

Name	Time	Method
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	after at least 7 days, i.e., at the time of round 3 (therapy end)

Secondary Outcome Measures

Name	Time	Method
clinical cure rate	at round 4 (follow-up: day 28 to 35)
bacteriological sensitivity into-vitro	at round 4 (follow-up: day 28 to 35)
time up to the drug-switch	at round 4 (follow-up: day 28 to 35)
bacteriological effectiveness on patients and seed level	at round 4 (follow-up: day 28 to 35)
time until the dismissal of the patients necessity of the gift of additional antibacterial drug	at round 4 (follow-up: day 28 to 35)
assessment of the effectiveness by the investigator	at round 4 (follow-up: day 28 to 35)
cost reduction of the antibiotic-therapy and the complete treatment	at round 4 (follow-up: day 28 to 35)

Trial Locations

Locations (8)

Medizinische Hochschule Hannover, Abteilung für Pneumologie; 🇩🇪 Hannover, Germany

Brüderkrankenhaus St. Josef , Innere Abteilung; 🇩🇪 Paderborn, Germany

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

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

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

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

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

Diakoniekrankenhaus Rotenburg gGmbH, Lungenklinik Unterstedt , Zentrum für Pneumologie; 🇩🇪 Rotenburg, Germany