Clinical trial NCT00887276: Study to Proof the Clinical and Bacteriological Non-inferiority of Ampicillin/Amoxicillin Versus Moxifloxacin in Hospitalized Patients With Non-severe Community-acquired Pneumonia
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Community Acquired Pneumonia
Keywords: Ampicillin
Amoxicillin
Moxifloxacin
Community-Acquired Pneumonia
Lead sponsor: University of Ulm
Sponsor class: OTHER
Collaborators: name: CAPNETZ Stiftung
First posted: 2009-04-23
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: after at least 7 days, i.e., at the time of round 3 (therapy end)
Secondary outcomes:
measure: clinical cure rate
timeFrame: at round 4 (follow-up: day 28 to 35)
measure: bacteriological effectiveness on patients and seed level
timeFrame: at round 4 (follow-up: day 28 to 35)
measure: bacteriological sensitivity into-vitro
timeFrame: at round 4 (follow-up: day 28 to 35)
measure: time up to the drug-switch
timeFrame: at round 4 (follow-up: day 28 to 35)
measure: time until the dismissal of the patients necessity of the gift of additional antibacterial drug
timeFrame: at round 4 (follow-up: day 28 to 35)
measure: cost reduction of the antibiotic-therapy and the complete treatment
timeFrame: at round 4 (follow-up: day 28 to 35)
measure: assessment of the effectiveness by the investigator
timeFrame: at round 4 (follow-up: day 28 to 35)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin ,Campus Virchow-Klinikum ,Medizinische Klinik : Infektiologie u. Pneumologie
city: Berlin
country: Germany
facility: HELIOS-Klinikum Emil von Behring ,Lungenklinik Heckeshorn
city: Bochum
country: Germany
facility: Klinikum der Ruhr Universität , Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil, Medizinische Klinik III
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover, Abteilung für Pneumologie
city: Lübeck
country: Germany
facility: Universitätsklinikum-Schleswig-Holstein, Campus Lübeck, Zentralklinikum, MK III, Studienzentrum Pneumologie-Infektiologie-Onkologie,
city: Paderborn
country: Germany
facility: Brüderkrankenhaus St. Josef , Innere Abteilung
city: Rotenburg
country: Germany
facility: Diakoniekrankenhaus Rotenburg gGmbH, Lungenklinik Unterstedt , Zentrum für Pneumologie
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm Sektion Pneumologie/Klinik für Innere Medizin II
Study officials:
affiliation: Hannover Medical School
name: Tobias Welte, Prof.
role: PRINCIPAL_INVESTIGATOR
References: