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

Sponsors

Lead Sponsor: University of Ulm

Collaborator: CAPNETZ Stiftung

Source University of Ulm
Brief 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.

Overall Status Terminated
Start Date November 2008
Completion Date January 2011
Primary Completion Date January 2011
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure 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
Measure 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)
Enrollment 290
Condition
Intervention

Intervention Type: Drug

Intervention Name: Moxifloxacin

Description: 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

Arm Group Label: Moxifloxacin

Other Name: Avalox

Intervention Type: Drug

Intervention Name: Ampicillin;Amoxicillin

Description: 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

Arm Group Label: Ampicillin; Amoxicillin

Eligibility

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Tobias Welte, Prof. Principal Investigator Hannover Medical School
Location
Facility:
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
Medizinische Hochschule Hannover, Abteilung für Pneumologie | Hannover, Germany
Universitätsklinikum-Schleswig-Holstein, Campus Lübeck, Zentralklinikum, MK III, Studienzentrum Pneumologie-Infektiologie-Onkologie, | Lübeck, Germany
Brüderkrankenhaus St. Josef , Innere Abteilung | Paderborn, Germany
Diakoniekrankenhaus Rotenburg gGmbH, Lungenklinik Unterstedt , Zentrum für Pneumologie | Rotenburg, Germany
Universitätsklinikum Ulm Sektion Pneumologie/Klinik für Innere Medizin II | Ulm, Germany
Location Countries

Germany

Verification Date

January 2010

Responsible Party

Name Title: Prof. Dr. Reinhard Marre

Organization: University of Ulm

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Moxifloxacin

Type: Active Comparator

Label: Ampicillin; Amoxicillin

Type: Active Comparator

Acronym PENCAP
Study Design Info

Allocation: Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov