Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Capnetz Stiftung | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moxifloxacin | Active Comparator |
| |
| Ampicillin; Amoxicillin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moxifloxacin | Drug | intravenous infusion: at least 3 days until to the drug switch (oral use),3 times daily (all 8 hours)
following oral therapy(possible at the earliest day 4): 3 times daily (all 8 hours):
Total time of the therapy:at least 7 days, but at most 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| clinical cure rate | 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) | |
| bacteriological sensitivity into-vitro |
Not provided
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:
Negative legionella antigen test in the urine
CRB-65-Index < 3
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tobias Welte, Prof. | Hannover Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Universitätsmedizin Berlin ,Campus Virchow-Klinikum ,Medizinische Klinik : Infektiologie u. Pneumologie | Berlin | Germany | ||||
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Ampicillin;Amoxicillin | Drug | intravenous infusion:at least 3 days until to the drug switch (oral use), 3 times daily (all 8 hours)
following oral therapy(possible at the earliest day 4): 3 times daily (all 8 hours):
Total time of the therapy: at least 7 days, but at most 10 days |
|
|
| at round 4 (follow-up: day 28 to 35) |
| time up to the drug-switch | 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) |
| cost reduction of the antibiotic-therapy and the complete treatment | 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) |
| 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 |
| ID | Term |
|---|---|
| D000098968 | Community-Acquired Pneumonia |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided