Bacterial Pneumonia
Conditions
Brief summary
Study 0019 (NCT00124020) compares the safety and effectiveness of an investigational drug, telavancin, with vancomycin for the treatment of hospital-acquired pneumonia.
Interventions
DRUGTelavancin
Telavancin 10 mg/kg/day IV for up to 21 days
DRUGVancomycin
Vancomycin 1 Gm administered every 12 hrs IV for up to 21 days
Sponsors
Cumberland Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Response | 7-14 days following end of antibiotic treatment | 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 |
Countries
Israel
Participant flow
Recruitment details
Enrollment Period: 23 January 2005 to 02 May 2007
Pre-assignment details
14 patients (9 telavancin and 5 vancomycin) enrolled in the study but never started study treatment
Participants by arm
| Arm | Count |
|---|---|
| Telavancin Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs | 377 |
| Vancomycin Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV every 12 hrs. | 380 |
| Total | 757 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 67 | 71 |
| Overall Study | Lost to Follow-up | 5 | 8 |
| Overall Study | Other | 1 | 1 |
| Overall Study | Transfer to another hospital | 2 | 0 |
| Overall Study | Withdrawal by Subject | 13 | 11 |
Baseline characteristics
| Characteristic | Total | Telavancin | Vancomycin |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 391 Participants | 195 Participants | 196 Participants |
| Age, Categorical Between 18 and 65 years | 366 Participants | 182 Participants | 184 Participants |
| Age, Continuous | 62 years STANDARD_DEVIATION 17.9 | 61 years STANDARD_DEVIATION 17.8 | 62 years STANDARD_DEVIATION 18 |
| Diabetes Status Diabetic | 134 participants | 69 participants | 65 participants |
| Diabetes Status Non-Diabetic | 623 participants | 308 participants | 315 participants |
| History of Pneumonia No prior history of pneumonia | 675 participants | 340 participants | 335 participants |
| History of Pneumonia Prior history of pneumonia | 82 participants | 37 participants | 45 participants |
| Region of Enrollment Argentina | 39 participants | 20 participants | 19 participants |
| Region of Enrollment Australia | 23 participants | 9 participants | 14 participants |
| Region of Enrollment Brazil | 33 participants | 17 participants | 16 participants |
| Region of Enrollment Bulgaria | 40 participants | 20 participants | 20 participants |
| Region of Enrollment Canada | 13 participants | 3 participants | 10 participants |
| Region of Enrollment Chile | 5 participants | 0 participants | 5 participants |
| Region of Enrollment China | 64 participants | 27 participants | 37 participants |
| Region of Enrollment Croatia | 4 participants | 2 participants | 2 participants |
| Region of Enrollment Czech Republic | 4 participants | 3 participants | 1 participants |
| Region of Enrollment Estonia | 1 participants | 0 participants | 1 participants |
| Region of Enrollment France | 2 participants | 1 participants | 1 participants |
| Region of Enrollment Georgia | 30 participants | 17 participants | 13 participants |
| Region of Enrollment Greece | 2 participants | 1 participants | 1 participants |
| Region of Enrollment Israel | 76 participants | 38 participants | 38 participants |
| Region of Enrollment Korea, Republic of | 53 participants | 23 participants | 30 participants |
| Region of Enrollment Lebanon | 9 participants | 5 participants | 4 participants |
| Region of Enrollment Lithuania | 17 participants | 7 participants | 10 participants |
| Region of Enrollment Mexico | 60 participants | 31 participants | 29 participants |
| Region of Enrollment Philippines | 17 participants | 8 participants | 9 participants |
| Region of Enrollment Poland | 10 participants | 6 participants | 4 participants |
| Region of Enrollment Romania | 7 participants | 4 participants | 3 participants |
| Region of Enrollment Russian Federation | 50 participants | 21 participants | 29 participants |
| Region of Enrollment Serbia | 17 participants | 7 participants | 10 participants |
| Region of Enrollment Slovakia | 12 participants | 6 participants | 6 participants |
| Region of Enrollment South Africa | 10 participants | 7 participants | 3 participants |
| Region of Enrollment Spain | 2 participants | 0 participants | 2 participants |
| Region of Enrollment Thailand | 33 participants | 22 participants | 11 participants |
| Region of Enrollment Ukraine | 18 participants | 12 participants | 6 participants |
| Region of Enrollment United States | 106 participants | 60 participants | 46 participants |
| Sex: Female, Male Female | 249 Participants | 125 Participants | 124 Participants |
| Sex: Female, Male Male | 508 Participants | 252 Participants | 256 Participants |
| Ventilator Status Non-ventilated | 407 participants | 202 participants | 205 participants |
| Ventilator Status Ventilated | 350 participants | 175 participants | 175 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 295 / 379 | 296 / 378 |
| serious Total, serious adverse events | 107 / 379 | 109 / 378 |
Outcome results
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
Time frame: 7-14 days following end of antibiotic treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Telavancin | Clinical Response | Cured | 227 participants |
| Telavancin | Clinical Response | Failure | 53 participants |
| Telavancin | Clinical Response | Indeterminate | 39 participants |
| Telavancin | Clinical Response | Missing | 58 participants |
| Vancomycin | Clinical Response | Missing | 62 participants |
| Vancomycin | Clinical Response | Cured | 228 participants |
| Vancomycin | Clinical Response | Indeterminate | 38 participants |
| Vancomycin | Clinical Response | Failure | 52 participants |
95% CI: [-6.8, 7.2]