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

Sponsor

University of Ulm (Other)

Overall Status

Terminated

CT.gov ID

NCT00887276

Collaborator

CAPNETZ Stiftung (Other)

290

Enrollment

Locations

Arms

Duration (Months)

36.3

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Community Acquired Pneumonia	Drug: Moxifloxacin Drug: Ampicillin;Amoxicillin	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

290 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Nov 1, 2008

Actual Primary Completion Date :

Jan 1, 2011

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

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

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

Outcome Measures

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 [after at least 7 days, i.e., at the time of round 3 (therapy end)]

Secondary Outcome Measures

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

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