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

Sponsor:	University of Ulm
Collaborator:	CAPNETZ Stiftung
Information provided by:	University of Ulm
ClinicalTrials.gov Identifier:	NCT00887276

Purpose

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.

Condition	Intervention	Phase
Community Acquired Pneumonia	Drug: Moxifloxacin Drug: Ampicillin;Amoxicillin	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia

Drug Information available for: Ampicillin sodium Ampicillin Amoxicillin Amoxicillin sodium Amoxicillin trihydrate Moxifloxacin Moxifloxacin hydrochloride Ampicillin trihydrate

U.S. FDA Resources

Further study details as provided by University of Ulm:

Primary Outcome Measures:

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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

clinical cure rate [ Time Frame: at round 4 (follow-up: day 28 to 35) ] [ Designated as safety issue: No ]
bacteriological effectiveness on patients and seed level [ Time Frame: at round 4 (follow-up: day 28 to 35) ] [ Designated as safety issue: No ]
bacteriological sensitivity into-vitro [ Time Frame: at round 4 (follow-up: day 28 to 35) ] [ Designated as safety issue: No ]
time up to the drug-switch [ Time Frame: at round 4 (follow-up: day 28 to 35) ] [ Designated as safety issue: No ]
time until the dismissal of the patients necessity of the gift of additional antibacterial drug [ Time Frame: at round 4 (follow-up: day 28 to 35) ] [ Designated as safety issue: No ]
cost reduction of the antibiotic-therapy and the complete treatment [ Time Frame: at round 4 (follow-up: day 28 to 35) ] [ Designated as safety issue: No ]
assessment of the effectiveness by the investigator [ Time Frame: at round 4 (follow-up: day 28 to 35) ] [ Designated as safety issue: No ]

Estimated Enrollment:	290
Study Start Date:	November 2008
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Moxifloxacin	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 Name: Avalox
Active Comparator: Ampicillin; Amoxicillin	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

Arms

Assigned Interventions

Active Comparator: Moxifloxacin

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 Name: Avalox

Active Comparator: Ampicillin; Amoxicillin

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00887276

Contacts

Contact: Grit Barten	+49- (511) -532-4434	barten.grit@mh-hannover.de
Contact: Waldemar Kroener	+49- (511) -532-4448	kroener.waldemar@mh-hannover.de

Locations

Germany
HELIOS-Klinikum Emil von Behring ,Lungenklinik Heckeshorn	Recruiting
Berlin, Germany
Charité - Universitätsmedizin Berlin ,Campus Virchow-Klinikum ,Medizinische Klinik : Infektiologie u. Pneumologie	Recruiting
Berlin, Germany
Klinikum der Ruhr Universität , Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil, Medizinische Klinik III	Recruiting
Bochum, Germany
Medizinische Hochschule Hannover, Abteilung für Pneumologie	Recruiting
Hannover, Germany
Universitätsklinikum-Schleswig-Holstein, Campus Lübeck, Zentralklinikum, MK III, Studienzentrum Pneumologie-Infektiologie-Onkologie,	Recruiting
Lübeck, Germany
Brüderkrankenhaus St. Josef , Innere Abteilung	Recruiting
Paderborn, Germany
Diakoniekrankenhaus Rotenburg gGmbH, Lungenklinik Unterstedt , Zentrum für Pneumologie	Recruiting
Rotenburg, Germany
Universitätsklinikum Ulm Sektion Pneumologie/Klinik für Innere Medizin II	Recruiting
Ulm, Germany

Sponsors and Collaborators

University of Ulm

CAPNETZ Stiftung

Investigators

Principal Investigator:

Tobias Welte, Prof.

Hannover Medical School

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Prof. Dr. Reinhard Marre, University of Ulm
ClinicalTrials.gov Identifier:	NCT00887276 History of Changes
Other Study ID Numbers:	EudraCT number: 2005-000771-18
Study First Received:	April 22, 2009
Last Updated:	January 11, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Ulm:

Ampicillin
Amoxicillin
Moxifloxacin
Community-Acquired Pneumonia

Additional relevant MeSH terms:

Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Amoxicillin
Ampicillin
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012