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

Community Acquired Pneumonia Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00887276
• Other study ID #: EudraCT number: 2005-000771-18
• Status: Terminated
• Phase: Phase 4
• First received: April 22, 2009
• Last updated: December 16, 2014
• Start date: November 2008
• Est. completion date: January 2011

Study information

• Verified date: January 2010
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 290
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Community Acquired Pneumonia
• Pneumonia

Intervention

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
• 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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Ulm	CAPNETZ Stiftung

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	clinical cure rate		at round 4 (follow-up: day 28 to 35)	No
Secondary	bacteriological effectiveness on patients and seed level		at round 4 (follow-up: day 28 to 35)	No
Secondary	bacteriological sensitivity into-vitro		at round 4 (follow-up: day 28 to 35)	No
Secondary	time up to the drug-switch		at round 4 (follow-up: day 28 to 35)	No
Secondary	time until the dismissal of the patients necessity of the gift of additional antibacterial drug		at round 4 (follow-up: day 28 to 35)	No
Secondary	cost reduction of the antibiotic-therapy and the complete treatment		at round 4 (follow-up: day 28 to 35)	No
Secondary	assessment of the effectiveness by the investigator		at round 4 (follow-up: day 28 to 35)	No

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