Therapy of Complicated Intra-Abdominal Infections With Moxifloxacin or Ertapenem

This study has been completed.

Study NCT00492726 Information provided by Bayer

First Received on June 26, 2007. Last Updated on May 5, 2011 History of Changes

Results First Received: February 11, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Infection
Interventions:	Drug: Moxifloxacin (Avelox, BAY12-8039) Drug: Ertapenem intravenous

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
Subjects were enrolled from 02 July 2006 to 31 December 2008 at 52 centers in 14 countries: Argentina (9), Belgium (3), Bulgaria (4), Estonia (3), France (2 ), Germany (5), Greece (1), Israel (2), Latvia (6), Lithuania (4), Romania (5), Russia (3), South Africa (3), and Spain (2).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
830 subjects screened, 804 randomized. 6 not treated. Safety/Intent to treat population = 798 subjects with at least 1 dose taken and 1 observation after intake (Moxifloxacin 408; Ertapenem 390). Per protocol population = 699 subjects with no major protocol deviations that would have influenced the primary outcome (Moxifloxacin 352; Ertapenem 347).

Reporting Groups

	Description
Moxifloxacin (Avelox, BAY 12-8039)	Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
Ertapenem	Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.

Participant Flow: Overall Study

	Moxifloxacin (Avelox, BAY 12-8039)	Ertapenem
STARTED	410	394
End of Treatment (EOT, Day 5 to 14)	387	377
End of Study	360	358
COMPLETED	360	358
NOT COMPLETED	50	36
Adverse Event	10	6
Death	7	2
Lack of Efficacy	0	2
Lost to Follow-up	27	19
Physician Decision	0	1
Withdrawal by Subject	6	3
Non compliant with study medication	0	3

Baseline Characteristics

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Reporting Groups

	Description
Moxifloxacin (Avelox, BAY 12-8039)	Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
Ertapenem	Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.

Baseline Measures

	Moxifloxacin (Avelox, BAY 12-8039)	Ertapenem	Total
Number of Participants [units: participants]	410	394	804
Age [units: years] Mean ± Standard Deviation	48.1 ± 18.3	47.0 ± 18.2	47.4 ± 18.2
Gender [units: participants]
Female	156	131	287
Male	254	263	517

Outcome Measures

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1. Primary:

Number of Subjects Achieving Clinical Cure at Test of Cure (TOC) Visit in the Per Protocol Population [ Time Frame: 21 to 28 days after completion of study drug therapy ]

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2. Secondary:

Number of Subjects Achieving Clinical Improvement During Treatment in the Per Protocol Population [ Time Frame: During treatment at day 5 +/- 1 day ]

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3. Secondary:

Number of Subjects Achieving Bacteriological Success During Treatment in the Per Protocol Population With Causative Organism(s) [ Time Frame: During treatment at day 5 +/- 1 day ]

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4. Secondary:

Number of Subjects Achieving Clinical Cure at End of Therapy (EOT) Visit in the Per Protocol Population [ Time Frame: after 5 - 14 days of therapy ]

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5. Secondary:

Number of Subjects Achieving Bacteriological Success at EOT Visit in the Per Protocol Population With Causative Organism(s) [ Time Frame: After 5 - 14 days of therapy ]

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6. Secondary:

Number of Subjects Achieving Bacteriological Success at TOC Visit in the Per Protocol Population With Causative Organism(s) [ Time Frame: 21 - 28 days after end of therapy ]

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7. Secondary:

Number of Subjects Achieving Clinical Cure at TOC Visit in the Per Protocol Population With Causative Organism(s) [ Time Frame: 21 - 28 days after end of therapy ]

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8. Secondary:

Number of Subjects Who Died Due to Intra-abdominal Infections [ Time Frame: 21 - 28 days after end of treatment at TOC Visit ]

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9. Secondary:

Duration of Hospitalization [ Time Frame: From the first admission date to the discharge date (from 4 to 71 days after start of study medication) ]

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10. Secondary:

Duration of Hospitalization Postoperatively [ Time Frame: Duration of hospitalization after the first surgery until discharge date (from 4 to 71 days after start of study medication) ]

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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. Restriction Description: The agreed point of publication is 12/18 months after database lock at the earliest. Bayer will have up to 30/45 days to review publications and may request an additional publication delay of up to 60 days to allow for filing a patent application (if applicable). No publication of single center data should be done prior of publication if multi-center data.

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
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Results Point of Contact:

Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com

No publications provided

Responsible Party:	Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier:	NCT00492726 History of Changes
Other Study ID Numbers:	11976, EudraCT: 2006-000874-56
Study First Received:	June 26, 2007
Results First Received:	February 11, 2010
Last Updated:	May 5, 2011
Health Authority:	Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment