To Compare Safety and Efficacy of Doripenem Versus Imipenem-Cilastatin in Patients With Ventilator-Associated Pneumonia

This study has been terminated.

(Observed lower cure rates and higher mortality rates in one of the treatment groups.)

Sponsor:

Information provided by (Responsible Party):

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

ClinicalTrials.gov Identifier:

NCT00589693

First received: December 21, 2007

Last updated: December 24, 2012

Last verified: December 2012

History of Changes

Results First Received: June 13, 2012

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:	Ventilator-Associated Pneumonia
Interventions:	Drug: Doripenem Drug: Imipenem-Cilastatin Drug: Placebo

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
274 enrolled patients were randomnly assigned to the 127 study centers. 524 patients were to be enrolled, however as the study was terminated early only 274 patients were actually enrolled.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of 274 randomized patients, 41 patients were excluded (as their sites were GCP Non-Compliant) and 6 patients were not treated. Treated patients=227 (115 doripenem and 112 imipenem-cilastatin).

Reporting Groups

	Description
Doripenem	1 g 4-hour infusion intravenously every 8 hour for 7 days
Imipenem-cilastatin	1 g 1-hour infusion intravenously every 8 hour for 10 days

Participant Flow: Overall Study

	Doripenem	Imipenem-cilastatin
STARTED	115	112
COMPLETED	71	83
NOT COMPLETED	44	29
randomized in error	12	6
Adverse Event	4	4
Death	26	16
Lack of Efficacy	0	1
Lost to Follow-up	1	0
Physician Decision	0	1
Protocol Violation	1	1

Baseline Characteristics

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Reporting Groups

	Description
Doripenem	1 g 4-hour infusion intravenously every 8 hour for 7 days
Imipenem-cilastatin	1 g 1-hour infusion intravenously every 8 hour for 10 days
Total	Total of all reporting groups

Baseline Measures

	Doripenem	Imipenem-cilastatin	Total
Number of Participants [units: participants]	115	112	227
Age [units: participants]
<=18 years	0	1	1
Between 18 and 65 years	72	72	144
>=65 years	43	39	82
Age [units: years] Mean ± Standard Deviation	57.5 ± 16.53	54.6 ± 18.46	56.1 ± 17.53
Gender [units: participants]
Female	43	37	80
Male	72	75	147
Region Enroll [units: participants]
EUROPE	69	71	140
NORTH AMERICA	16	12	28
REST OF WORLD	9	6	15
SOUTH AMERICA	21	23	44

Outcome Measures

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1. Primary:

Clinical Cure Rate at the End-of-treatment (EOT) Visit [ Time Frame: End-of-treatment (Day 10 or Day 11) ]

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2. Secondary:

Clinical Cure Rate at the End-of-treatment (EOT) Visit in Patients From Whom a Qualifying P. Aeruginosa Was Isolated at Baseline [ Time Frame: End-of-treatment (Day 10 or Day 11) ]

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3. Secondary:

Clinical Cure Rate at the End-of-treatment (EOT) Visit in Patients From Whom at Least 1 of the Gram-negative Qualifying Pneumonia Pathogens (Enterobacteriaceae, P. Aeruginosa, and Acinetobacter Spp) Was Isolated at Baseline [ Time Frame: End-of-treatment (Day 10 or Day 11) ]

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4. Secondary:

Number of Patients Who Had Emergence of P. Aeruginosa Resistance [ Time Frame: Up to 6 weeks ]

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5. Secondary:

28-day All-cause Mortality Rate [ Time Frame: Up to 28 days ]

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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
41 patients (21 doripenem, 20 imipenem-cilastatin) were enrolled at 5 sites that were found to be Good Clinical Practice non-compliant and were excluded from the primary efficacy and safety analyses.

Results Point of Contact:

Name/Title: Sr Director Clinical Development
Organization: Janssen R&D US
phone: 1 510 248-2310

No publications provided

Responsible Party:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00589693 History of Changes
Other Study ID Numbers:	CR014038, DORINOS3008, 2007-004646-33
Study First Received:	December 21, 2007
Results First Received:	June 13, 2012
Last Updated:	December 24, 2012
Health Authority:	United States: Food and Drug Administration Canada: Health Canada Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines India: Ministry of Health Philippines: Bureau of Food and Drugs Ukraine: State Pharmacological Center - Ministry of Health

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