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Completed

NCT Number: NCT00111644

A Study to Assess Beta-Lactam in the Treatment of Hospitalized Patients 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.

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Key information

Conditions

Pneumonia, Bacterial Bacterial Infections Bacterial Infections and Mycoses Infections Lung Diseases Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ceftriaxone

Drug

1000mg iv daily

beta-lactam

Drug

750mg iv q 23h for 3-14 days

Primary outcomes

  1. Clinical cure rate\n\n

    Time frame: End of study visit (7-10 days after end of treatment)

Secondary outcomes

  1. Adverse events, vital signs, laboratory parameters\n

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
May 25, 2005
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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