Study to Proof the Clinical and Bacteriological Non-inferiority of Ampicillin/Amoxicillin Versus Moxifloxacin in Hospitalized Patients With Non-severe Community-acquired Pneumonia
NCT ID: NCT00887276
Last Updated: 2014-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
290 participants
INTERVENTIONAL
2008-11-30
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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Moxifloxacin
Moxifloxacin
intravenous infusion: at least 3 days until to the drug switch (oral use),3 times daily (all 8 hours)
1. 20 ml physiologic saline solution (placebo)(over 30 min) + Moxifloxacin infusion solution(400 mg/250ml) over 60 minutes
2. 20 ml physiologic saline solution (placebo) (over 30 min)
3. 20 ml physiologic saline solution (placebo) (over 30 min)
following oral therapy(possible at the earliest day 4): 3 times daily (all 8 hours):
1. 1 capsule Moxifloxacin (400 mg) + 1 capsule Placebo
2. 2 capsules Placebo
3. 2 capsules Placebo
Total time of the therapy:at least 7 days, but at most 10 days
Ampicillin; Amoxicillin
Ampicillin;Amoxicillin
intravenous infusion:at least 3 days until to the drug switch (oral use), 3 times daily (all 8 hours)
1. 2 g Ampicillin dissolved in 20 ml aqua (i.v. over 30 min) + 250 ml physiologic saline solution (placebo) (over 60 min)
2. 2 g Ampicillin dissolved in 20 ml aqua (i.v. over 30 min)
3. 2 g Ampicillin dissolved in 20 ml aqua (i.v. over 30 min)
following oral therapy(possible at the earliest day 4): 3 times daily (all 8 hours):
1. 2 capsules Amoxicillin (0,5 g)
2. 2 capsules Amoxicillin (0,5 g)
3. 2 capsules Amoxicillin (0,5 g)
Total time of the therapy: at least 7 days, but at most 10 days
Interventions
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Moxifloxacin
intravenous infusion: at least 3 days until to the drug switch (oral use),3 times daily (all 8 hours)
1. 20 ml physiologic saline solution (placebo)(over 30 min) + Moxifloxacin infusion solution(400 mg/250ml) over 60 minutes
2. 20 ml physiologic saline solution (placebo) (over 30 min)
3. 20 ml physiologic saline solution (placebo) (over 30 min)
following oral therapy(possible at the earliest day 4): 3 times daily (all 8 hours):
1. 1 capsule Moxifloxacin (400 mg) + 1 capsule Placebo
2. 2 capsules Placebo
3. 2 capsules Placebo
Total time of the therapy:at least 7 days, but at most 10 days
Ampicillin;Amoxicillin
intravenous infusion:at least 3 days until to the drug switch (oral use), 3 times daily (all 8 hours)
1. 2 g Ampicillin dissolved in 20 ml aqua (i.v. over 30 min) + 250 ml physiologic saline solution (placebo) (over 60 min)
2. 2 g Ampicillin dissolved in 20 ml aqua (i.v. over 30 min)
3. 2 g Ampicillin dissolved in 20 ml aqua (i.v. over 30 min)
following oral therapy(possible at the earliest day 4): 3 times daily (all 8 hours):
1. 2 capsules Amoxicillin (0,5 g)
2. 2 capsules Amoxicillin (0,5 g)
3. 2 capsules Amoxicillin (0,5 g)
Total time of the therapy: at least 7 days, but at most 10 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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CAPNETZ Stiftung
OTHER
University of Ulm
OTHER
Responsible Party
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University of Ulm
Principal Investigators
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Tobias Welte, Prof.
Role: PRINCIPAL_INVESTIGATOR
Hannover Medical School
Locations
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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
Hanover, , 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 (Wümme), , Germany
Universitätsklinikum Ulm Sektion Pneumologie/Klinik für Innere Medizin II
Ulm, , Germany
Countries
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Related Links
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Related Info
Other Identifiers
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EudraCT number: 2005-000771-18
Identifier Type: -
Identifier Source: org_study_id