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

University of Ulm

Status and phase

Terminated

Phase 4

Conditions

Community Acquired Pneumonia

Treatments

Drug: Ampicillin;Amoxicillin

Drug: Moxifloxacin

Study type

Interventional

Funder types

Other

Identifiers

NCT00887276

EudraCT number: 2005-000771-18

Details and patient eligibility

About

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.

Enrollment

290 patients

Sex

All

Ages

18+ years old

Volunteers

No 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