Prospective, doubleblind, randomized multicenter study to proof the clinical and bacteriological non-inferiority of amoxicillin versus moxifloxacin in hospitalized patients with non-severe community-acquired pneumonia - PENCAP
- Conditions
- •new arrises infiltrate (radiograph thorax)•existence of at least two of following symptoms: onew or increasing cough odyspnea omucopurulent or purulent sputum ofever (body temperature >= 37,8 °C auriculary and/or >=38,3°c rectal)MedDRA version: 9.1Level: LLTClassification code 10010120Term: Community acquired pneumonia
- Registration Number
- EUCTR2005-000771-18-DE
- Lead Sponsor
- niversitätsklinikum Ulm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 290
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<3
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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) •<br> bacteriological effectiveness on patients and seed level •<br> bacteriological sensitivity into-vitro •<br> time up to the medicine-switch with patients with Fine-Score IV-V • <br>time until the dismissal of the patients necessity of the gift of additional antibacterial medicine • <br>cost reduction of the antibiotic-therapy and the complete treatment<br>assessment of the effectiveness by the investigator (differentiation:recovery, healing, therapy failure, not determined)<br>;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
- Secondary Outcome Measures
Name Time Method