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

April 22, 2009
January 11, 2010
November 2008
January 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00887276 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Community Acquired Pneumonia
  • 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
  • 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
  • Active Comparator: Moxifloxacin
    Intervention: Drug: Moxifloxacin
  • Active Comparator: Ampicillin; Amoxicillin
    Intervention: Drug: Ampicillin;Amoxicillin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
290
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Grit Barten +49- (511) -532-4434 barten.grit@mh-hannover.de
Contact: Waldemar Kroener +49- (511) -532-4448 kroener.waldemar@mh-hannover.de
Germany
 
NCT00887276
EudraCT number: 2005-000771-18
No
Prof. Dr. Reinhard Marre, University of Ulm
University of Ulm
CAPNETZ Stiftung
Principal Investigator: Tobias Welte, Prof. Hannover Medical School
University of Ulm
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP