InfectionPhase 3NCT01254344

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

A Phase 3 study testing ertapenem sodium, ceftriaxone sodium and metronidazole in people with Infection and Surgical Site Infection, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Infection, Surgical Site Infection
What is being tested?: ertapenem sodium, ceftriaxone sodium and metronidazole
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 599 participants
Where: No sites listed yet
Study dates: Dec 2010to Dec 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participant is scheduled to undergo elective colon or colorectal surgery by
laparotomy that is scheduled in advance with adequate time prior to surgery to
complete preoperative bowel preparation.
Participant is a Chinese adult between the ages of more than 18 years old and
less than 81 years old.
Participant is highly unlikely to conceive.

Who cannot join

Participant is undergoing emergency colon or colorectal surgery.
Participant requires a second planned colorectal surgery or other surgery requiring antibiotic prophylaxis within the 4-week follow-up period.
Participant is undergoing laparoscopic-assisted surgery.
Participant is undergoing an isolated rectal procedure.
Participant has a decompensated intestinal obstruction.
Participant has active inflammatory bowel disease involving the colon (i.e.,

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ulcerative colitis or Crohn's disease).
Participant is scheduled to undergo an elective colorectal procedure for revision of a previous operation involving a large bowel resection.
Participant has a bacterial infection at the time of surgery.
Participant requires or is anticipated to need the administration of other (nonstudy therapy) systemic antimicrobial therapy within 1 week prior to surgery or at any time during this study.
Participant is anticipated to receive either antibiotic or antiseptic peritoneal lavage during the surgery.
Participant has a history of serious allergy, hypersensitivity (e.g., anaphylaxis), or any serious reaction to ertapenem sodium, ceftriaxone sodium, metronidazole, penicillin, or any cephalosporin, beta(β)-lactam, or nitroimidazole agents.
Participant is breast feeding or plans to breast feed prior to the completion of the study period.
Participant has neutropenia.
Participant with immunosuppression due to an underlying disease, chronic
immunosuppressive therapy, or use of high-dose corticosteroids.
Participant has a rapidly progressive or terminal illness.
Participant is considered unlikely to survive through the expected 4-week study period.

About this study

Official title: A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Efficacy and Safety of Ertapenem Sodium (MK-0826) Versus Ceftriaxone Sodium/Metronidazole for the Prophylaxis of Surgical Site Infection Following Elective Colorectal Surgery in Chinese Adults

The purpose of this study is to evaluate the efficacy and safety of ertapenem sodium compared with ceftriaxone sodium/metronidazole for the prophylaxis of surgical site infection following elective colorectal surgery in Chinese adults. This study is designed to demonstrate that ertapenem sodium is non-inferior to ceftriaxone sodium/metronidazole in this participant population.

Conditions: Infection, Surgical Site Infection
Being tested: ertapenem sodium, ceftriaxone sodium, placebo to metronidazole, metronidazole
Keywords: Colorectal surgery
Medical subject headings: Infections, Surgical Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ertapenem sodiumDrug
Also called MK-0826, INVANZ®
Ertapenem sodium 1 g administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision
ceftriaxone sodiumDrug
Also called Rocephin®
Ceftriaxone sodium 2 g administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision
placebo to metronidazoleDrug
Placebo (0.9% sodium chloride) administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision
metronidazoleDrug
Also called Flagyl®
Metronidazole 500 mg administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision

Study groups in NCT01254344
Study group	Role	What they receive
Ertapenem sodium 1 g	Experimental	Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose Receives: Drug: ertapenem sodium; Drug: placebo to metronidazole
Ceftriaxone sodium 2 g	Active comparator	Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose Receives: Drug: ceftriaxone sodium; Drug: metronidazole

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Success of Prophylaxis
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
Measured: From study drug dose (day of surgery) up to 4 weeks post therapy

Secondary outcomes (1)

Percentage of Participants With Favorable Clinical Response
Percentage of participants who have no signs or symptoms of infection at the surgical site and do not require surgical intervention for infection
Measured: 4 weeks posttreatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2010Dec 2011

First posted6 Dec 2010 (estimated)
Study startDec 2010
Primary completionDec 2011
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for InfectionStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 599 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01254344
Sponsor's protocol ID: 0826-056
Status last verified: Feb 2017
First submitted: 3 Dec 2010
Last updated: 22 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Publications

Leng XS, Zhao YJ, Qiu HZ, Cao YK, Zhu WH, Shen JF, Paschke A, Dai WM, Caldwell N, Wang J. Ertapenem prophylaxis of surgical site infections in elective colorectal surgery in China: a multicentre, randomized, double-blind, active-controlled study. J Antimicrob Chemother. 2014 Dec;69(12):3379-86. doi: 10.1093/jac/dku302. Epub 2014 Aug 23.
PubMed 25151205

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Efficacy and Safety of Ertapenem Sodium (MK-0826) Versus Ceftriaxone Sodium/Metronidazole for the Prophylaxis of Surgical Site Infection Following Elective Colorectal Surgery in Chinese Adults
ClinicalTrials.gov ID: NCT01254344
Acronym / sponsor ID: 0826-056
Conditions: Infection, Surgical Site Infection
Keywords: Colorectal surgery
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 599 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Dec 2010
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 6 Dec 2010 (estimated)
Results: Posted 16 Nov 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Ertapenem sodium 1 g	Experimental	Drug: ertapenem sodium, Drug: placebo to metronidazoleErtapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose
Ceftriaxone sodium 2 g	Active comparator	Drug: ceftriaxone sodium, Drug: metronidazoleCeftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Participant is scheduled to undergo elective colon or colorectal surgery by
laparotomy that is scheduled in advance with adequate time prior to surgery to
complete preoperative bowel preparation.
Participant is a Chinese adult between the ages of more than 18 years old and
less than 81 years old.

Key exclusion criteria (18 listed)

Participant is undergoing emergency colon or colorectal surgery.
Participant requires a second planned colorectal surgery or other surgery requiring antibiotic prophylaxis within the 4-week follow-up period.
Participant is undergoing laparoscopic-assisted surgery.
Participant is undergoing an isolated rectal procedure.
Participant has a decompensated intestinal obstruction.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ertapenem sodiumAlso: MK-0826, INVANZ®Ertapenem sodium 1 g administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision	Drug	Ertapenem sodium 1 g
ceftriaxone sodiumAlso: Rocephin®Ceftriaxone sodium 2 g administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision	Drug	Ceftriaxone sodium 2 g
placebo to metronidazolePlacebo (0.9% sodium chloride) administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision	Drug	Ertapenem sodium 1 g
metronidazoleAlso: Flagyl®Metronidazole 500 mg administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision	Drug	Ceftriaxone sodium 2 g

Primary outcome

Percentage of Participants With Success of Prophylaxis
Time frame: From study drug dose (day of surgery) up to 4 weeks post therapy
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

1 secondary outcome

Percentage of Participants With Favorable Clinical Response
Time frame: 4 weeks posttreatment

Results and safety

Results posted to the registry on 16 Nov 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ertapenem	299	286
Ceftriaxone/Metronidazole	300	281

Primary outcome: Percentage of Participants With Success of Prophylaxis

Time frame: From study drug dose (day of surgery) up to 4 weeks post therapy. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Ertapenem n = 251	Ceftriaxone/Metronidazole n = 248
Value	90.4 (86.8 to 94.1)	90.3 (86.6 to 94.0)

Ertapenem vs Ceftriaxone/Metronidazole: Difference in percentage of prophylaxis: 0.1 (95% CI -5.2 to 5.5), Miettinen and Nurminen

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to and including 28 days after last administration of study drug. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ertapenem	6 of 290 (2.1%)	23 of 290 (7.9%)	Not reported
Ceftriaxone/Metronidazole	14 of 297 (4.7%)	18 of 297 (6.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 25151205Leng XS, Zhao YJ, Qiu HZ, Cao YK, Zhu WH, Shen JF, Paschke A, Dai WM, Caldwell N, Wang J. Ertapenem prophylaxis of surgical site infections in elective colorectal surgery in China: a multicentre, randomized, double-blind, active-controlled study. J Antimicrob Chemother. 2014 Dec;69(12):3379-86. doi: 10.1093/jac/dku302. Epub 2014 Aug 23.
Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ertapenem sodium, ceftriaxone sodium and metronidazole in people with Infection and Surgical Site Infection, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Success of Prophylaxis (time frame: From study drug dose (day of surgery) up to 4 weeks post therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01254344, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2017.