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

NCT00887276 | Terminated Phase 4

• 1 other identifier: EudraCT number: 2005-000771-18
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 8

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.

Conditions

Community Acquired Pneumonia

Keywords

Ampicillin; Amoxicillin; Moxifloxacin; Community-Acquired Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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)

Study Arms (2)

Moxifloxacin

ACTIVE COMPARATOR

Drug: Moxifloxacin

Ampicillin; Amoxicillin

ACTIVE COMPARATOR

Drug: Ampicillin;Amoxicillin

Interventions

Moxifloxacin DRUG

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

Also known as: Avalox

Moxifloxacin

Ampicillin;Amoxicillin DRUG

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

Also known as: Ampicillin Ratiopharm, Amoxicillin ratiopharm

Ampicillin; Amoxicillin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ulm: lead
• CAPNETZ Stiftung: collaborator

Study Sites (8)

Charité - Universitätsmedizin Berlin ,Campus Virchow-Klinikum ,Medizinische Klinik : Infektiologie u. Pneumologie

Berlin, Germany

Location

HELIOS-Klinikum Emil von Behring ,Lungenklinik Heckeshorn

Berlin, Germany

Location

Klinikum der Ruhr Universität , Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil, Medizinische Klinik III

Bochum, Germany

Location

Medizinische Hochschule Hannover, Abteilung für Pneumologie

Hanover, Germany

Location

Universitätsklinikum-Schleswig-Holstein, Campus Lübeck, Zentralklinikum, MK III, Studienzentrum Pneumologie-Infektiologie-Onkologie,

Lübeck, Germany

Location

Brüderkrankenhaus St. Josef , Innere Abteilung

Paderborn, Germany

Location

Diakoniekrankenhaus Rotenburg gGmbH, Lungenklinik Unterstedt , Zentrum für Pneumologie

Rotenburg (Wümme), Germany

Location

Universitätsklinikum Ulm Sektion Pneumologie/Klinik für Innere Medizin II

Ulm, Germany

Location

Related Links

• Related Info

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Tobias Welte, Prof.

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 22, 2009
• First Posted: April 23, 2009
• Study Start: November 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: December 17, 2014

Record last verified: 2010-01

Locations

DE (8)