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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00107952
Other study ID # 0015
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date February 2005
Est. completion date July 2007

Study information

Verified date January 2019
Source Cumberland Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Study 0015 (NCT00107952) 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 761
Est. completion date July 2007
Est. primary completion date July 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

Study Design


Intervention

Drug:
Telavancin
Telavancin 10 mg/kg/day IV for up to 21 days.
Vancomycin
Vancomycin 1 Gm IV q 12 hrs for up to 21 days

Locations

Country Name City State
United States Baystate Medical Center Springfield Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Cumberland Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical Response Clinical Response: Categorical (Cured, Failed or Indeterminate)
Failure is 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
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