Community Acquired Pneumonia | Study to Proof the Clinical and Bacteriological Non-inferiority of Ampicillin/Amoxicillin Versus Moxifloxacin in Hospitalized Patients With Non-severe Community-acquired Pneumonia
Community Acquired Pneumonia research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Community Acquired Pneumonia
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Moxifloxacinintravenous infusion: at least 3 days until to the drug switch (oral use),3 times daily (all 8 hours) 20 ml physiologic saline solution (placebo)(over 30 min) + Moxifloxacin infusion solution(400 mg/250ml) over 60 minutes 20 ml physiologic saline solution (placebo) (over 30 min) 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 capsule Moxifloxacin (400 mg) + 1 capsule Placebo 2 capsules Placebo 2 capsules Placebo Total time of the therapy:at least 7 days, but at most 10 days
Drug:Ampicillin;Amoxicillinintravenous infusion:at least 3 days until to the drug switch (oral use), 3 times daily (all 8 hours) 2 g Ampicillin dissolved in 20 ml aqua (i.v. over 30 min) + 250 ml physiologic saline solution (placebo) (over 60 min) 2 g Ampicillin dissolved in 20 ml aqua (i.v. over 30 min) 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): 2 capsules Amoxicillin (0,5 g) 2 capsules Amoxicillin (0,5 g) 2 capsules Amoxicillin (0,5 g) Total time of the therapy: at least 7 days, but at most 10 days
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: November 2008
Completed Date: January 2011
Phase: Phase 4
Primary Outcome: 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
Secondary Outcome: clinical cure rate
Study sponsors, principal investigator, and references
Principal Investigator: Tobias Welte, Prof.
Lead Sponsor: University of Ulm
Collaborator: CAPNETZ Stiftung