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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Ulm.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
CAPNETZ Stiftung
Information provided by:
University of Ulm
ClinicalTrials.gov Identifier:
NCT00887276
First received: April 22, 2009
Last updated: January 11, 2010
Last verified: January 2010
  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 4

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:


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)

  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

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)

  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Moxifloxacin
Amoxicillin
Ampicillin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014