FindTrial
Sign In

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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00107952
Acronym
ATTAIN1
Enrollment
761
Registered
2005-04-12
Start date
2005-02-28
Completion date
2007-07-31
Last updated
2019-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Pneumonia

Keywords

Nosocomial pneumonia, MRSA

Brief summary

Study 0015 (NCT00107952) 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 IV q 12 hrs for up to 21 days

Sponsors

Cumberland Pharmaceuticals
Lead SponsorINDUSTRY

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

MeasureTime frameDescription
Clinical Response7 - 14 days following end of antibiotic treatmentClinical 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

Countries

United States

Participant flow

Recruitment details

Enrollment Period: 08Feb05 to 11Jul07

Participants by arm

ArmCount
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.
372
Vancomycin
Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV administered every 12 hrs.
374
Total746

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath7561
Overall StudyLost to Follow-up03
Overall StudyNever received study treatment96
Overall StudyOther25
Overall StudyWithdrawal by Subject96

Baseline characteristics

CharacteristicVancomycinTelavancinTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
212 Participants202 Participants414 Participants
Age, Categorical
Between 18 and 65 years
162 Participants170 Participants332 Participants
Age, Continuous64 years
STANDARD_DEVIATION 17.3
63 years
STANDARD_DEVIATION 19.2
64 years
STANDARD_DEVIATION 18.3
Diabetes Status
Diabetic
100 Participants100 Participants200 Participants
Diabetes Status
Non-Diabetic
274 Participants272 Participants546 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
66 Participants78 Participants144 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
308 Participants294 Participants602 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
History of Pneumonia
No prior history of pneumonia
321 participants310 participants631 participants
History of Pneumonia
Prior history of pneumonia
53 participants62 participants115 participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants2 Participants2 Participants
Race (NIH/OMB)
Asian
87 Participants91 Participants178 Participants
Race (NIH/OMB)
Black or African American
14 Participants10 Participants24 Participants
Race (NIH/OMB)
More than one race
1 Participants1 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
272 Participants267 Participants539 Participants
Region of Enrollment
Argentina
24 participants24 participants48 participants
Region of Enrollment
Australia
25 participants20 participants45 participants
Region of Enrollment
Belgium
5 participants3 participants8 participants
Region of Enrollment
Brazil
14 participants12 participants26 participants
Region of Enrollment
Canada
10 participants14 participants24 participants
Region of Enrollment
Chile
5 participants9 participants14 participants
Region of Enrollment
Croatia
31 participants28 participants59 participants
Region of Enrollment
Czech Republic
1 participants0 participants1 participants
Region of Enrollment
France
17 participants15 participants32 participants
Region of Enrollment
Greece
8 participants4 participants12 participants
Region of Enrollment
India
41 participants44 participants85 participants
Region of Enrollment
Israel
24 participants25 participants49 participants
Region of Enrollment
Italy
4 participants3 participants7 participants
Region of Enrollment
Malaysia
7 participants13 participants20 participants
Region of Enrollment
Malta
1 participants2 participants3 participants
Region of Enrollment
Peru
3 participants2 participants5 participants
Region of Enrollment
Poland
2 participants0 participants2 participants
Region of Enrollment
South Africa
2 participants2 participants4 participants
Region of Enrollment
Taiwan
34 participants29 participants63 participants
Region of Enrollment
Turkey
1 participants2 participants3 participants
Region of Enrollment
United Kingdom
2 participants4 participants6 participants
Region of Enrollment
United States
113 participants117 participants230 participants
Sex: Female, Male
Female
161 Participants137 Participants298 Participants
Sex: Female, Male
Male
213 Participants235 Participants448 Participants
Ventilator Status
Non-ventilated
203 Participants202 Participants405 Participants
Ventilator Status
Ventilated
171 Participants170 Participants341 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
321 / 372317 / 374
serious
Total, serious adverse events
127 / 37288 / 374

Outcome results

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

Time frame: 7 - 14 days following end of antibiotic treatment

ArmMeasureGroupValue (NUMBER)
TelavancinClinical ResponseCured214 participants
TelavancinClinical ResponseFailure46 participants
TelavancinClinical ResponseIndeterminate56 participants
TelavancinClinical ResponseMissing56 participants
VancomycinClinical ResponseMissing44 participants
VancomycinClinical ResponseCured221 participants
VancomycinClinical ResponseIndeterminate41 participants
VancomycinClinical ResponseFailure68 participants
95% CI: [-8.6, 5.5]

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026