Trial Outcomes & Findings for Efficacy and Safety of Ertapenem Sodium (MK-0826) Following Colorectal Surgery in Chinese Adults (MK-0826-056) (NCT NCT01254344)

NCT ID: NCT01254344

Last Updated: 2017-03-22

Results Overview

Percentage of participants who have no signs or symptoms of infection at the surgical site, do not require surgical intervention for infection, and have no need for further antimicrobial therapy

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 599 participants
• Primary outcome timeframe: From study drug dose (day of surgery) up to 4 weeks post therapy
• Results posted on: 2017-03-22

Participant Flow

Participant milestones

Measure	Ertapenem Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose	Ceftriaxone/Metronidazole Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose
Overall Study STARTED	299	300
Overall Study Treated	290	297
Overall Study COMPLETED	286	281
Overall Study NOT COMPLETED	13	19

Reasons for withdrawal

Measure	Ertapenem Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose	Ceftriaxone/Metronidazole Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose
Overall Study Adverse Event	2	5
Overall Study Physician Decision	7	4
Overall Study Protocol Violation	1	4
Overall Study Withdrawal by Subject	3	6

Baseline Characteristics

Efficacy and Safety of Ertapenem Sodium (MK-0826) Following Colorectal Surgery in Chinese Adults (MK-0826-056)

Baseline characteristics by cohort

Measure	Ertapenem n=290 Participants Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose	Ceftriaxone/Metronidazole n=297 Participants Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose	Total n=587 Participants Total of all reporting groups
Age, Continuous	59.4 years STANDARD_DEVIATION 11.4 • n=93 Participants	59.1 years STANDARD_DEVIATION 12.1 • n=4 Participants	59.2 years STANDARD_DEVIATION 11.8 • n=27 Participants
Sex: Female, Male Female	125 Participants n=93 Participants	127 Participants n=4 Participants	252 Participants n=27 Participants
Sex: Female, Male Male	165 Participants n=93 Participants	170 Participants n=4 Participants	335 Participants n=27 Participants

PRIMARY outcome

Timeframe: From study drug dose (day of surgery) up to 4 weeks post therapy

Population: Primary analysis results are for "evaluable-patients-only", defined as patients who received a complete dose of prophylaxis, underwent elective colorectal surgery with completion of bowel preparation procedure, had primary skin closure of the wound, and did not receive any prohibited systemic antibiotics or other prohibited anti-infective agents.

Percentage of participants who have no signs or symptoms of infection at the surgical site, do not require surgical intervention for infection, and have no need for further antimicrobial therapy

Outcome measures

Measure	Ertapenem n=251 Participants Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose	Ceftriaxone/Metronidazole n=248 Participants Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose
Percentage of Participants With Success of Prophylaxis	90.4 percentage of participants Interval 86.8 to 94.1	90.3 percentage of participants Interval 86.6 to 94.0

SECONDARY outcome

Timeframe: 4 weeks posttreatment

Population: Population analyzed was participants who had no signs or symptoms of infection at the surgical site and did not require surgical intervention for infection.

Percentage of participants who have no signs or symptoms of infection at the surgical site and do not require surgical intervention for infection

Outcome measures

Measure	Ertapenem n=251 Participants Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose	Ceftriaxone/Metronidazole n=248 Participants Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose
Percentage of Participants With Favorable Clinical Response	96.8 percentage of participants Interval 94.6 to 99.0	95.5 percentage of participants Interval 93.0 to 98.1

Adverse Events

Ertapenem

Serious events: 6 serious events

Other events: 23 other events

Deaths: 0 deaths

Ceftriaxone/Metronidazole

Serious events: 14 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ertapenem n=290 participants at risk Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose	Ceftriaxone/Metronidazole n=297 participants at risk Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose
Cardiac disorders Cardiac Arrest	0.00% 0/290 • Up to and including 28 days after last administration of study drug	0.34% 1/297 • Number of events 1 • Up to and including 28 days after last administration of study drug
Cardiac disorders Cardiac Failure Acute	0.00% 0/290 • Up to and including 28 days after last administration of study drug	0.34% 1/297 • Number of events 1 • Up to and including 28 days after last administration of study drug
Gastrointestinal disorders Intestinal Obstruction	0.34% 1/290 • Number of events 1 • Up to and including 28 days after last administration of study drug	0.00% 0/297 • Up to and including 28 days after last administration of study drug
Gastrointestinal disorders Vomiting	0.00% 0/290 • Up to and including 28 days after last administration of study drug	0.34% 1/297 • Number of events 1 • Up to and including 28 days after last administration of study drug
Hepatobiliary disorders Cholecystitis	0.00% 0/290 • Up to and including 28 days after last administration of study drug	0.34% 1/297 • Number of events 1 • Up to and including 28 days after last administration of study drug
Hepatobiliary disorders Cholecystitis Acute	0.00% 0/290 • Up to and including 28 days after last administration of study drug	0.34% 1/297 • Number of events 1 • Up to and including 28 days after last administration of study drug
Infections and infestations Incision Site Infection	0.00% 0/290 • Up to and including 28 days after last administration of study drug	0.34% 1/297 • Number of events 1 • Up to and including 28 days after last administration of study drug
Infections and infestations Pelvic Abscess	0.00% 0/290 • Up to and including 28 days after last administration of study drug	0.34% 1/297 • Number of events 1 • Up to and including 28 days after last administration of study drug
Injury, poisoning and procedural complications Abdominal Wound Dehiscence	0.00% 0/290 • Up to and including 28 days after last administration of study drug	0.34% 1/297 • Number of events 1 • Up to and including 28 days after last administration of study drug
Injury, poisoning and procedural complications Anastomotic Fistula	0.34% 1/290 • Number of events 1 • Up to and including 28 days after last administration of study drug	0.34% 1/297 • Number of events 1 • Up to and including 28 days after last administration of study drug
Injury, poisoning and procedural complications Anastomotic Leak	1.0% 3/290 • Number of events 3 • Up to and including 28 days after last administration of study drug	0.34% 1/297 • Number of events 1 • Up to and including 28 days after last administration of study drug
Injury, poisoning and procedural complications Post Procedural Haemorrhage	0.34% 1/290 • Number of events 1 • Up to and including 28 days after last administration of study drug	0.00% 0/297 • Up to and including 28 days after last administration of study drug
Injury, poisoning and procedural complications Wound Dehiscence	0.00% 0/290 • Up to and including 28 days after last administration of study drug	0.67% 2/297 • Number of events 2 • Up to and including 28 days after last administration of study drug
Nervous system disorders Vocal Cord Paralysis	0.00% 0/290 • Up to and including 28 days after last administration of study drug	0.34% 1/297 • Number of events 1 • Up to and including 28 days after last administration of study drug
Vascular disorders Embolism Venous	0.00% 0/290 • Up to and including 28 days after last administration of study drug	0.34% 1/297 • Number of events 1 • Up to and including 28 days after last administration of study drug
Vascular disorders Venous Thrombosis Limb	0.00% 0/290 • Up to and including 28 days after last administration of study drug	0.34% 1/297 • Number of events 1 • Up to and including 28 days after last administration of study drug

Other adverse events

Measure	Ertapenem n=290 participants at risk Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose	Ceftriaxone/Metronidazole n=297 participants at risk Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose
General disorders Pyrexia	7.9% 23/290 • Number of events 24 • Up to and including 28 days after last administration of study drug	6.1% 18/297 • Number of events 19 • Up to and including 28 days after last administration of study drug

Additional Information

Naimi Missoum

Merck Sharp & Dohme (China) Ltd.

Phone: +8621 2211 8546

Email: naimi_missoum@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
• Publication restrictions are in place

Restriction type: OTHER