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 (ATTAIN 1) - ATTAIN 1

• Conditions: Hospital-Acquired Pneumonia with a Focus on Patients with Infections Due to Methicillin-Resistant Staphylococcus aureus; MedDRA version: 6.1Level: LLTClassification code 10052596

• Registration Number: EUCTR2004-002902-31-CZ
• Lead Sponsor: Theravance, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07-25
• Last Update Posted: 3 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

Patients who meet all of the following criteria will be eligible for study enrollment.

1. Male and female patients = 18 years old.
2. 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 = 3 days duration.
3. A chest radiograph with findings consistent with a diagnosis of pneumonia (new or
progressive infiltrates, consolidation, or pleural effusion) within 48 hours prior to
randomization in the study.
4. Availability of appropriate respiratory or sputum specimens for Gram stain and
culture, and venous access for IV dosing.
5. Willing to receive IV therapy for the duration of treatment.
6. Informed consent can be obtained for participation in this study as defined by the
local Institutional Review Board or Ethics Committee.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients who satisfy any of the following criteria are not eligible for study enrollment.

1. a) Received more than 24 hours of potentially effective systemic (IV/IM or PO)
antibiotic therapy prior to randomization, (unless documented to be a treatment
failure or if the isolated pathogen for the current pneumonia was resistant in vitro
to previous treatment), and/or b) Requires non-study systemic antibiotic potentially effective against the baseline pathogen for another reason during the study
2. Respiratory tract specimens or sputum with only Gram-negative bacteria seen on
Gram stain or culture.
3. Known infection with MSSA or S. pneumoniae and patient will require more than
24 hours of concomitant study medication therapy with an antibiotic for Gram-negative coverage that has activity versus MSSA or S. pneumoniae (e.g., piperacillin-tazobactam or imipenem).
4. Known or suspected pulmonary disease that precludes evaluation of therapeutic
response (e.g., granulomatous diseases, lung cancer, or another malignancy metastatic to the lungs); cystic fibrosis or active tuberculosis.
5. Known or suspected Legionella pneumophila pneumonia.
6. Known or suspected infection with an organism that is not susceptible to medications permitted by the protocol should be excluded.
7. Documented or suspected meningitis, endocarditis, or osteomyelitis.
8. Sustained shock defined as supine systolic blood pressure < 90 mm Hg for > 2 hours despite adequate fluid resuscitation, with evidence of hypoperfusion or requirement for sympathomimetic agents to maintain blood pressure.
9. Baseline QTc > 500 msec, congenital long QT syndrome, uncompensated heart
failure, or uncorrected abnormal K+ or Mg++ blood levels.
10. Severely neutropenic (absolute neutrophil count < 500/mm³) or anticipated to
develop severe neutropenia during the study treatment period due to prior or planned chemotherapy, or have HIV with CD4 count < 100/mm³ during the last 6 months
11. Requirement for concomitant administration of intravenous Sporanox® (itraconazole)
or Vfend® (voriconazole) or any other medication containing a cyclodextrin solubilizer
12. a) Female patients of childbearing potential if they are pregnant, nursing, or unable to use a highly effective method of birth control during the study and for at least one month following the last dose of study medication. A negative serum
pregnancy result must be documented prior to treatment. A highly effective
method of birth control is defined as one that results in a low failure rate (i.e., < 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence, or a vasectomized partner.
b) Male patients must agree to use medically acceptable birth control for a least
three months following last dose of study medication. A vasectomy or a condom
used with a spermicide is a medically acceptable birth control method for males.
13. Prior enrollment in a clinical trial of telavancin.
14. Known hypersensitivity to, or intolerance of, study medications or their formulation excipients.
15. Treatment with another investigational medication within 30 days of study entry
16. Considered unlikely to survive at least 7 days due to underlying illness
17. Considered unlikely to comply with the study procedures or to return for scheduled post-treatment evaluations.
18. Any other condition that in the opinion of an investigator, would confound or interfere with evaluation of safety

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy and safety of telavancin to vancomycin in the treatment of adults with Gram-positive hospital-acquired pneumonia (HAP) with an emphasis on patients with infections due to methicillin-resistant Staphylococcus aureus (MRSA).;Secondary Objective: To pool the data from this study with those from a second study of identical design<br>(protocol 0019) and to assess the superiority of telavancin to vancomycin in patients<br>with MRSA infection.;Primary end point(s): The primary efficacy endpoint is the clinical response at the Test-of-Cure evaluation. For purpose of analysis, assessments of failure” at End-of-Therapy will be carried forward to Test-of-Cure.