Study to Proof the Clinical and Bacteriological Non-inferiority of Ampicillin/Amoxicillin Versus Moxifloxacin in Hospitalized Patients With Non-severe Community-acquired Pneumonia

Phase 4TerminatedNCT00887276

University of Ulm290 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

290

Conditions

Community Acquired Pneumonia

Interventions

MoxifloxacinDRUG

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;AmoxicillinDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

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

Outcomes

Primary Outcomes

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

Time frame: after at least 7 days, i.e., at the time of round 3 (therapy end)