Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus (ATTAIN1)

This study has been completed.

Sponsor:

Information provided by:

Theravance, Inc.

ClinicalTrials.gov Identifier:

NCT00107952

First received: April 11, 2005

Last updated: April 6, 2012

Last verified: April 2012

History of Changes

Results First Received: November 3, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Bacterial Pneumonia
Interventions:	Drug: Telavancin Drug: Vancomycin

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment Period: 08Feb05 to 11Jul07

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
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.
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.

Participant Flow: Overall Study

	Telavancin	Vancomycin
STARTED	381	380
COMPLETED	286	299
NOT COMPLETED	95	81
Death	75	61
Lost to Follow-up	0	3
Withdrawal by Subject	9	6
Other	2	5
Never received study treatment	9	6

Baseline Characteristics

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Reporting Groups

	Description
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.
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.
Total	Total of all reporting groups

Baseline Measures

	Telavancin	Vancomycin	Total
Number of Participants [units: participants]	372	374	746
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	170	162	332
>=65 years	202	212	414
Age [units: years] Mean ± Standard Deviation	63 ± 19.2	64 ± 17.3	64 ± 18.3
Gender [units: participants]
Female	137	161	298
Male	235	213	448
Ethnicity (NIH/OMB) [units: Participants]
Hispanic or Latino	78	66	144
Not Hispanic or Latino	294	308	602
Unknown or Not Reported	0	0	0
Race (NIH/OMB) [units: Participants]
American Indian or Alaska Native	2	0	2
Asian	91	87	178
Native Hawaiian or Other Pacific Islander	1	0	1
Black or African American	10	14	24
White	267	272	539
More than one race	1	1	2
Unknown or Not Reported	0	0	0
Region of Enrollment [units: participants]
Argentina	24	24	48
Australia	20	25	45
Belgium	3	5	8
Brazil	12	14	26
Canada	14	10	24
Chile	9	5	14
Croatia	28	31	59
Czech Republic	0	1	1
France	15	17	32
Greece	4	8	12
India	44	41	85
Israel	25	24	49
Italy	3	4	7
Malaysia	13	7	20
Malta	2	1	3
Peru	2	3	5
Poland	0	2	2
South Africa	2	2	4
Taiwan	29	34	63
Turkey	2	1	3
United Kingdom	4	2	6
United States	117	113	230
Diabetes Status [units: Participants]
Diabetic	100	100	200
Non-Diabetic	272	274	546
History of Pneumonia [units: participants]
Prior history of pneumonia	62	53	115
No prior history of pneumonia	310	321	631
Ventilator Status [units: Participants]
Ventilated	170	171	341
Non-ventilated	202	203	405

Outcome Measures

1. Primary:

Clinical Response [ Time Frame: 7 - 14 days following end of antibiotic treatment ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Steve Barriere, Pharm.D., Vice President, Clinical and Medical Affairs
Organization: Theravance, Inc
phone: 650-808-6132
e-mail: sbarriere@theravance.com

No publications provided

Responsible Party:	Steven Barriere, Pharm.D., Vice President, Clinical and Medical Affairs, Theravance, Inc.
ClinicalTrials.gov Identifier:	NCT00107952 History of Changes
Other Study ID Numbers:	0015
Study First Received:	April 11, 2005
Results First Received:	November 3, 2009
Last Updated:	April 6, 2012
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Argentina: Human Research Bioethics Committee Argentina: Ministry of Health Australia: Department of Health and Ageing Therapeutic Goods Administration Australia: Human Research Ethics Committee Australia: National Health and Medical Research Council Belgium: Directorate general for the protection of Public health: Medicines Belgium: Federal Agency for Medicinal Products and Health Products Belgium: Institutional Review Board Belgium: Ministry of Social Affairs, Public Health and the Environment Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment Brazil: Ethics Committee Brazil: Ministry of Health Brazil: National Committee of Ethics in Research Brazil: National Health Surveillance Agency Canada: Canadian Institutes of Health Research Canada: Ethics Review Committee Canada: Health Canada Canada: Ministry of Health & Long Term Care, Ontario Chile: Comisión Nacional de Investigación Científica y Tecnológica Chile: Instituto de Salud Publica de Chile Croatia: Agency for Medicinal Product and Medical Devices Croatia: Ethics Committee Croatia: Ministry of Health and Social Care Croatia: Ministry of Science, Education and Sports Czech Republic: Ethics Committee Czech Republic: State Institute for Drug Control France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Direction Générale de la Santé France: French Data Protection Authority France: Haute Autorité de Santé Transparency Commission France: Institutional Ethical Committee France: Ministry of Health France: National Consultative Ethics Committee for Health and Life Sciences Greece: Ethics Committee Greece: Ministry of Health and Welfare Greece: National Organization of Medicines India: Indian Council of Medical Research Israel: Ethics Commission Israel: Israeli Health Ministry Pharmaceutical Administration Israel: Ministry of Health Israel: The Israel National Institute for Health Policy Research and Health Services Research Italy: Ethics Committee Italy: Ministry of Health Italy: National Bioethics Committee Italy: National Institute of Health Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Italy: The Italian Medicines Agency Malaysia: Ministry of Health Malta: Medicines Authority Peru: Ethics Committee Peru: General Directorate of Pharmaceuticals, Devices, and Drugs Peru: Ministry of Health Poland: Ethics Committee Poland: Ministry of Health Poland: Ministry of Science and Higher Education Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products South Africa: Department of Health South Africa: Human Research Ethics Committee South Africa: Medicines Control Council South Africa: National Health Research Ethics Council Taiwan: Department of Health Taiwan: Institutional Review Board Taiwan: National Bureau of Controlled Drugs Turkey: Ministry of Health United Kingdom: Department of Health United Kingdom: Food Standards Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: National Health Service United Kingdom: Research Ethics Committee United States: Food and Drug Administration

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