• new arrises infiltrate (radiograph thorax) • existence of at least two of following symptoms: o new or increasing cough o dyspnea o mucopurulent or purulent sputum o fever (body temperature >= 37,8 °C auriculary and/or >=38,3°c rectal) MedDRA version: 9.1 Level: LLT Classification code 10010120 Term: Community acquired pneumonia
Conditions
Interventions
Product Name: Amoxicillin ratiopharm (R) 500
Product Code: Tradename present
Pharmaceutical Form: Capsule*
INN or Proposed INN: Amoxicillin-Trihydrat
CAS Number: 1336-10-7
Concentration unit: mg milli
Sponsors
Universitätsklinikum Ulm
Eligibility
Sex/Gender
All
Inclusion 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 o cough which is newly appeared or increasing o dyspnea o mucopurulent or purulent sputum o fever (body temperature >=37.8 degrees Celsius auricalary and/or >= 38,3°C rectal) o o positive auscultation•negative legionella antigen test in the urine •CRB-65-Index=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 pneumonia • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary end-point of this study is the clinical cure after at least 7 days, i.e. at the time of the round 3 (therapy end).;Secondary Objective: clinical cure rate at round 4 (follow-up:day 28 to 35) • bacteriological effectiveness on patients and seed level • bacteriological sensitivity into-vitro • time up to the medicine-switch with patients with Fine-Score IV-V • time until the dismissal of the patients necessity of the gift of additional antibacterial medicine • cost reduction of the antibiotic-therapy and the complete treatment assessment of the effectiveness by the investigator (differentiation:recovery, healing, therapy failure, not determined) ;Primary end point(s): Proof of the clinical not 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 | — |
Countries
Germany
Outcome results
None listed