Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus

Bacterial Pneumonia Clinical Trial

— ATTAIN2  

Official title:

A Phase 3, Randomized, Double-Blind, Parallel-Group, Multinational Trial of Intravenous Telavancin Versus Vancomycin for Treatment of Hospital-Acquired Pneumonia With a Focus on Patients With Infections Due to Methicillin-Resistant Staphylococcus Aureus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00124020
• Other study ID #: 0019
• Status: Completed
• Phase: Phase 3
• Start date: January 2005
• Est. completion date: May 2007

Study information

• Verified date: December 2018
• Source: Cumberland Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study 0019 (NCT00124020) compares the safety and effectiveness of an investigational drug, telavancin, with vancomycin for the treatment of hospital-acquired pneumonia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 771
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical signs and symptoms consistent with pneumonia acquired after at least 48 hours of continuous stay in an inpatient acute or chronic care facility or acquired within 7 days after being discharged from a hospitalization of greater than or equal to 3 days duration.

Exclusion Criteria:

• Received more than 24 hours of potentially effective systemic (IV, IM or PO) antibiotic therapy for Gram-positive pneumonia immediately prior to randomization.

Related Conditions & MeSH terms

• Bacterial Pneumonia
• Pneumonia
• Pneumonia, Bacterial
• Staphylococcal Infections

Intervention

Drug:
• Telavancin
Telavancin 10 mg/kg/day IV for up to 21 days
• Vancomycin
Vancomycin 1 Gm administered every 12 hrs IV for up to 21 days

Locations

Country	Name	City	State
Israel	Sheba Medical Center, Infectious Disease Unit	Tel Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Cumberland Pharmaceuticals

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Response	Clinical Response: Categorical (Cured, Failed or Indeterminate); Failure - at least one of the following: Persistence or progression of signs and symptoms of pneumonia that still require antibiotic therapy; Termination of study med due to "lack of efficacy"; Death on or after Day 3 attributable to primary infection; Cure: Signs and symptoms of pneumonia improved to the point that no further antibiotics for pneumonia were required, and baseline radiographic findings improved or did not progress.; Indeterminate: Inability to determine outcome	7-14 days following end of antibiotic treatment