Trial | NCT00887276  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    290
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 Started
Nov 30
2008
Primary Completion
Jan 31
2011
Study Completion
Jan 31
2011
Last Update
Dec 17
2014
Estimate

Drug Moxifloxacin

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

  • Other names: Avalox

Drug Ampicillin;Amoxicillin

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

  • Other names: Ampicillin Ratiopharm, Amoxicillin ratiopharm

Moxifloxacin Active Comparator

Ampicillin; Amoxicillin Active Comparator

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:

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
No Results Posted