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

Pneumonia, Bacterial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00111644
• Other study ID #: WI18273
• Status: Completed
• Phase: Phase 2
• First received: May 24, 2005
• Last updated: November 1, 2016
• Start date: March 2005
• Est. completion date: January 2007

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Bacterial

Intervention

Drug:
• Ceftriaxone
1000mg iv daily
• beta-lactam
750mg iv q 23h for 3-14 days
• beta-lactam
1500mg iv q 12h for 3-14 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical cure rate\n\n		End of study visit (7-10 days after end of treatment)	No
Secondary	Adverse events, vital signs, laboratory parameters\n		Throughout study	No