Randomized, Double-Blind, Parallel-Group, Multinational Trial of Intravenous Telavancin vs Vancomycin for Treatment of Hospital-Acquired Pneumonia with a Focus on Patients with Infections Due to MRSA
| Possible benefit: | Participants may receive medical benefit from participation through drug therapy |
| Purpose of trial: | To evaluate the safety and efficacy of telavancin compared to vancomycin |
| Drug/Device being tested: | Telavancin and Vancomycin |
| Sponsoring Department: | Internal Medicine, Division of Infectious Diseases |
| SIU Faculty Physician: | Janak Koirala, MD |
| Sponsoring Company: | Theravance |
| Ending date of study: | To be determined |
| SCRIHS Protocol Number: | 05-061 |
| Number of other sites in trial: | 418 |
| Type of patients needed: | 1. Signs and symptoms consistent with pneumonia acquired after 48 hours inpatient or chronic care or within 7 days of discharge from hospital stay exceeding 3 days 2. Chest radiograph consistent with pneumonia 3. Respiratory or sputum specimens for gram stain and culture and venous access for IV dosing Exclusions: 1. 24 hrs of potentially effective antibiotic 2. Respiratory or sputum specimens contain Gram negative only. 3. Female patients pregnant, nursing or unable to take birth control 4. Prior enrollment in a Telavancin trial 5. Hypersensitivity to study meds |
| Age: | 18 years of age and older |
| Health status: | See "Type of patients needed" section |
| Number of visits required: | Daily IV treatment twice a day for 7 to 21 days with follow-up visit and 10-week phone call follow-up |
| Length of study involvement: | 12 to 16 weeks |
| Tests to be performed: |
Blood draws, urine samples, ECGs, chest x-rays, sputum samples, intravenous infusions
|
| Contact Person: | Alys Adamski |
| Phone: | 217-545-9491 |
| E-Mail: | aadamski@siumed.edu |