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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00111644

Enrollment

302

Registered

2005-05-25

Start date

2005-03-31

Completion date

2007-01-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia, Bacterial

Brief summary

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.

Interventions

DRUGCeftriaxone

1000mg iv daily

DRUGbeta-lactam

750mg iv q 23h for 3-14 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
Adverse events, vital signs, laboratory parameters\n	Throughout study

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026