Back to results

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

Primary Purpose

Community Acquired Pneumonia

Status

Terminated

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Moxifloxacin

Ampicillin;Amoxicillin

About this trial

This is an interventional treatment trial for Community Acquired Pneumonia focused on measuring Ampicillin, Amoxicillin, Moxifloxacin, Community-Acquired Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Moxifloxacin

Ampicillin; Amoxicillin

Arm Description

Outcomes

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

Secondary Outcome Measures

clinical cure rate

bacteriological effectiveness on patients and seed level

bacteriological sensitivity into-vitro

time up to the drug-switch

time until the dismissal of the patients necessity of the gift of additional antibacterial drug

cost reduction of the antibiotic-therapy and the complete treatment

assessment of the effectiveness by the investigator

Full Information

NCT ID

NCT00887276

First Posted

April 22, 2009

Last Updated

December 16, 2014

Sponsor

University of Ulm

Collaborators

CAPNETZ Stiftung

1. Study Identification

Unique Protocol Identification Number

NCT00887276

Brief Title

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

Acronym

PENCAP

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2010

Overall Recruitment Status

Terminated

Study Start Date

November 2008 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Ulm

Collaborators

CAPNETZ Stiftung

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Community Acquired Pneumonia

Keywords

Ampicillin, Amoxicillin, Moxifloxacin, Community-Acquired Pneumonia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

290 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Moxifloxacin

Arm Type

Active Comparator

Arm Title

Ampicillin; Amoxicillin

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Moxifloxacin

Other Intervention Name(s)

Avalox

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Ampicillin;Amoxicillin

Other Intervention Name(s)

Ampicillin Ratiopharm, Amoxicillin ratiopharm

Intervention Description

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

Primary Outcome Measure Information:

Title

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)

Secondary Outcome Measure Information:

Title

clinical cure rate

Time Frame