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

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Doubleblind, Randomized Multicenter Study to Proof the Clinical and Bacteriological Non-inferiority of Ampicillin/Amoxicillin Versus Moxifloxacin in Hospitalized Patients With Non-severe Community-acquired Pneumonia

Conditions
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Community Acquired Pneumonia

Intervention / Treatment
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* Drug: Moxifloxacin
* Drug: Ampicillin;Amoxicillin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Moxifloxacin<br> | Drug: Moxifloxacin<br>* intravenous 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<br>* Other names: Avalox;|
| Active Comparator: Ampicillin; Amoxicillin<br> | Drug: Ampicillin;Amoxicillin<br>* intravenous 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<br>* Other names: Amoxicillin ratiopharm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ampicillin, Amoxicillin, Moxifloxacin, Community-Acquired Pneumonia