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

November 1, 2016 updated by: Hoffmann-La Roche

A Randomized, Double-blind Study of the Effect of Beta-lactam on Treatment Response in Patients Hospitalized With Bacterial Pneumonia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

302

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1180
      • Buenos Aires, Argentina, 1282
      • Buenos Aires, Argentina, 1657
      • Buenos Aires, Argentina, 1888
      • Buenos Aires, Argentina, 1427
      • Buenos Aires, Argentina, 1602
      • Buenos Aires, Argentina, BUE1430
      • Ciudadela, Argentina, 1702
      • Córdoba, Argentina, 5000
      • Córdoba, Argentina, X5004CDT
      • Granadero Baigorria, Argentina, 2152
      • Parana, Argentina, 3100
      • Rosario, Argentina, S2000DSV
  • Bulgaria
      • Ruse, Bulgaria, 7002
      • Sofia, Bulgaria, 1233
      • Sofia, Bulgaria, 1431
      • Sofia, Bulgaria, 1606
  • Chile
      • Santiago, Chile
      • Valdivia, Chile
  • Croatia
      • Zagreb, Croatia, 10000
  • Hungary
      • Budapest, Hungary, 1529
      • Nyiregyhaza, Hungary, 4400
      • Torokbalint, Hungary, 2045
      • Zalaegerszeg, Hungary, 8900
  • Latvia
      • Daugavpils, Latvia, 5417
      • Riga, Latvia, LV-1002
      • Riga, Latvia, 1038
  • Lithuania
      • Kaunas, Lithuania, 3000
      • Klaipeda, Lithuania, 92231
      • Vilnius, Lithuania, 08661
  • Peru
      • Lima, Peru, 11
      • Lima, Peru, 31
      • Lima, Peru, 1
  • Romania
      • Bucharest, Romania
      • Bucharest, Romania, 030303
      • Bucharest, Romania, 21659
      • Bucharest, Romania, 21105
      • Constanta, Romania, 8700
      • Craiova, Romania, 200515
  • Slovakia
      • Banska Bystrica, Slovakia, 975 17
      • Nitra, Slovakia, 949 88
      • Nitra, Slovakia, 950 01
      • Poprad, Slovakia, 058 87
  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
      • Shreveport, Louisiana, United States, 71105
    • Michigan
      • Detroit, Michigan, United States, 48201
    • Montana
      • Butte, Montana, United States, 59701
    • New Jersey
      • Holmdel, New Jersey, United States, 07733
    • North Carolina
      • Winston-salem, North Carolina, United States, 27103

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: beta-lactam
750mg iv q 23h for 3-14 days
Drug: beta-lactam
1500mg iv q 12h for 3-14 days
Experimental: 2
Drug: beta-lactam
750mg iv q 23h for 3-14 days
Drug: beta-lactam
1500mg iv q 12h for 3-14 days
Active Comparator: 3
Drug: Ceftriaxone
1000mg iv daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical cure rate\n\n
Time Frame: End of study visit (7-10 days after end of treatment)
End of study visit (7-10 days after end of treatment)

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events, vital signs, laboratory parameters\n
Time Frame: Throughout study
Throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

May 24, 2005

First Submitted That Met QC Criteria

May 24, 2005

First Posted (Estimate)

May 25, 2005

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WI18273

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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