NCT00887276

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 290 (actual)
• Sponsor: University of Ulm · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Community Acquired Pneumonia

Interventions

Type	Name	Description
DRUG	Moxifloxacin	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
DRUG	Ampicillin;Amoxicillin	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

Timeline

• Start date: 2008-11-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2009-04-23
• Last updated: 2014-12-17

Locations

8 sites across 1 country: Germany