A Study to Assess Beta-Lactam in the Treatment of Hospitalized Patients With Bacterial Pneumonia

NCT ID: NCT00111644

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

302 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2007-01-31

Brief Summary

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This study will assess the efficacy and safety of intravenous beta-lactam, in comparison with ceftriaxone, in hospitalized patients with community-acquired pneumonia not caused by Legionella. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

Detailed Description

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Conditions

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Pneumonia, Bacterial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

beta-lactam

Intervention Type DRUG

750mg iv q 23h for 3-14 days

2

Group Type EXPERIMENTAL

beta-lactam

Intervention Type DRUG

1500mg iv q 12h for 3-14 days

3

Group Type ACTIVE_COMPARATOR

Ceftriaxone

Intervention Type DRUG

1000mg iv daily

Interventions

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Ceftriaxone

1000mg iv daily

Intervention Type DRUG

beta-lactam

750mg iv q 23h for 3-14 days

Intervention Type DRUG

beta-lactam

1500mg iv q 12h for 3-14 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* male or female patients at least 18 years of age;
* hospitalization with community-acquired pneumonia or development of pneumonia within 48 hours of being hospitalized for another reason;
* fever;
* new or increased productive cough;
* chest pain, shortness of breath, or rapid breathing.

Exclusion Criteria

* requiring intubation or ventilation;
* nursing home or extended care within 60 days before study;
* concomitant bacterial infection requiring antibiotics;
* long-term immunosuppressive therapy.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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New Orleans, Louisiana, United States

Site Status

Shreveport, Louisiana, United States

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Detroit, Michigan, United States

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Butte, Montana, United States

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Holmdel, New Jersey, United States

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Winston-Salem, North Carolina, United States

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Ciudadela, , Argentina

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Córdoba, , Argentina

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Córdoba, , Argentina

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Granadero Baigorria, , Argentina

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Paraná, , Argentina

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Rosario, , Argentina

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Rousse, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Santiago, , Chile

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Valdivia, , Chile

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Zagreb, , Croatia

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Budapest, , Hungary

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Nyíregyháza, , Hungary

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Törökbálint, , Hungary

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Zalaegerszeg, , Hungary

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Daugavpils, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Kaunas, , Lithuania

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Klaipėda, , Lithuania

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Vilnius, , Lithuania

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Lima, , Peru

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Lima, , Peru

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Lima, , Peru

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Constanța, , Romania

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Craiova, , Romania

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Banská Bystrica, , Slovakia

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Nitra, , Slovakia

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Nitra, , Slovakia

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Poprad, , Slovakia

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Countries

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South Africa United States Argentina Bulgaria Chile Croatia Hungary Latvia Lithuania Peru Romania Slovakia

Other Identifiers

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WI18273

Identifier Type: -

Identifier Source: org_study_id