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

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.

Study Overview

• Status: Terminated
• Conditions: Community Acquired Pneumonia
• Intervention / Treatment: Drug: Moxifloxacin; Drug: Ampicillin;Amoxicillin

• Study Type: Interventional
• Enrollment (Actual): 290
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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

What is the study measuring?

Primary Outcome Measures

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 Measures

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)

Collaborators and Investigators

• Sponsor: University of Ulm
• Collaborators: CAPNETZ Stiftung

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: April 22, 2009
• First Submitted That Met QC Criteria: April 22, 2009
• First Posted (Estimate): April 23, 2009

Study Record Updates

• Last Update Posted (Estimate): December 17, 2014
• Last Update Submitted That Met QC Criteria: December 16, 2014
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: Ampicillin; Moxifloxacin; Amoxicillin; Community-Acquired Pneumonia
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Moxifloxacin; Ampicillin; Amoxicillin
• Other Study ID Numbers: EudraCT number: 2005-000771-18