Trial · NCT01014013

Safety and Tolerability of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-055)

NCT01014013, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2010-03-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Tolerability of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-055). Trials, record NCT01014013. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01014013

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Tolerability of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-055)
NCT number: NCT01014013
Status: Completed
Phases: Phase 3
Enrollment: 271 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Urinary Tract Infection
Interventions: ertapenem sodium (MK0826), Comparator: ceftriaxone sodium
First posted: 2009-11-16
Last updated: 2017-03-22
Results first posted: 2010-03-01

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Microbiological Response Assessment Profile	5 to 9 days post-therapy	The difference in favorable microbiological response rates between the 2 treatment groups (MK0826 response rate minus ceftriaxone response rate) was assessed
Primary	The Number of Patients Who Experience Any Drug-related Adverse Experiences Leading to Discontinuation of Parenteral Study Drug and the Number of Patients With Any Drug-related Serious Adverse Experiences (AEs) During Parenteral Treatment	Adverse experiences that occurred during the study parenteral therapy period were analyzed. The period of parenteral therapy is from 3 days up to 14 days	Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences, physical examination, vital signs, and laboratory results during parenteral therapy. As per the primary safety hypothesis, it was expected that, at the end of the parenteral therapy only, MK0826 would be similar to ceftriaxone with respect to the proportion of patients with any drug-related clinical or laboratory adverse experiences leading to discontinuation of study drug and also with respect to the proportion of patients with any serious drug-related adverse experiences.
Secondary	Clinical Response Assessment Profile	5 to 9 days post-therapy	The difference in favorable clinical response rates between the 2 treatment groups (MK0826 response rate minus ceftriaxone response rate) was assessed

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Microbiological Response Assessment Profile	5 to 9 days post-therapy	Primary efficacy analysis was done for 137 evaluable patients (66 patients from MK0826 and 71 patients from Ceftriaxone)	Participants	NUMBER
PRIMARY	The Number of Patients Who Experience Any Drug-related Adverse Experiences Leading to Discontinuation of Parenteral Study Drug and the Number of Patients With Any Drug-related Serious Adverse Experiences (AEs) During Parenteral Treatment	Adverse experiences that occurred during the study parenteral therapy period were analyzed. The period of parenteral therapy is from 3 days up to 14 days	Safety Analysis has been done 267 patients who received at least 1 dose of parenteral therapy (132 patients from MK0826 and 135 patients from Ceftriaxone)	Participants	NUMBER
SECONDARY	Clinical Response Assessment Profile	5 to 9 days post-therapy	Secondary efficacy analysis was done for 137 evaluable patients (66 patients from MK0826 and 71 patients from Ceftriaxone)	Participants	NUMBER

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Microbiological Response Assessment Profile	MK0826		58	Participants
Microbiological Response Assessment Profile	Ceftriaxone		63	Participants
The Number of Patients Who Experience Any Drug-related Adverse Experiences Leading to Discontinuation of Parenteral Study Drug and the Number of Patients With Any Drug-related Serious Adverse Experiences (AEs) During Parenteral Treatment	MK0826	Discontinued due to drug-related clinical AEs	1	Participants
The Number of Patients Who Experience Any Drug-related Adverse Experiences Leading to Discontinuation of Parenteral Study Drug and the Number of Patients With Any Drug-related Serious Adverse Experiences (AEs) During Parenteral Treatment	Ceftriaxone	Discontinued due to drug-related clinical AEs	0	Participants
The Number of Patients Who Experience Any Drug-related Adverse Experiences Leading to Discontinuation of Parenteral Study Drug and the Number of Patients With Any Drug-related Serious Adverse Experiences (AEs) During Parenteral Treatment	MK0826	Serious drug-related clinical AEs	0	Participants
The Number of Patients Who Experience Any Drug-related Adverse Experiences Leading to Discontinuation of Parenteral Study Drug and the Number of Patients With Any Drug-related Serious Adverse Experiences (AEs) During Parenteral Treatment	Ceftriaxone	Serious drug-related clinical AEs	0	Participants
The Number of Patients Who Experience Any Drug-related Adverse Experiences Leading to Discontinuation of Parenteral Study Drug and the Number of Patients With Any Drug-related Serious Adverse Experiences (AEs) During Parenteral Treatment	MK0826	Discontinued due to drug-related laboratory AEs	1	Participants
The Number of Patients Who Experience Any Drug-related Adverse Experiences Leading to Discontinuation of Parenteral Study Drug and the Number of Patients With Any Drug-related Serious Adverse Experiences (AEs) During Parenteral Treatment	Ceftriaxone	Discontinued due to drug-related laboratory AEs	1	Participants
The Number of Patients Who Experience Any Drug-related Adverse Experiences Leading to Discontinuation of Parenteral Study Drug and the Number of Patients With Any Drug-related Serious Adverse Experiences (AEs) During Parenteral Treatment	MK0826	Serious drug-related Laboratory AEs	0	Participants
The Number of Patients Who Experience Any Drug-related Adverse Experiences Leading to Discontinuation of Parenteral Study Drug and the Number of Patients With Any Drug-related Serious Adverse Experiences (AEs) During Parenteral Treatment	Ceftriaxone	Serious drug-related Laboratory AEs	0	Participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow10

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	MK0826	135
Overall Study	STARTED	Ceftriaxone	136
Overall Study	Adverse Event Reporting	MK0826	132
Overall Study	Adverse Event Reporting	Ceftriaxone	135
Overall Study	Completed Parenteral Therapy	MK0826	87
Overall Study	Completed Parenteral Therapy	Ceftriaxone	88
Overall Study	COMPLETED	MK0826	84
Overall Study	COMPLETED	Ceftriaxone	80
Overall Study	NOT COMPLETED	MK0826	51
Overall Study	NOT COMPLETED	Ceftriaxone	56

Source ClinicalTrials.gov

Adverse events356

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Diarrhea	Gastrointestinal disorders	MK0826	27	132
other	Diarrhea	Gastrointestinal disorders	Ceftriaxone	20	135
other	Dyspepsia	Gastrointestinal disorders	MK0826	8	132
other	Dyspepsia	Gastrointestinal disorders	Ceftriaxone	15	135
other	Constipation	Gastrointestinal disorders	MK0826	9	132
other	Constipation	Gastrointestinal disorders	Ceftriaxone	9	135
other	Nausea	Gastrointestinal disorders	MK0826	8	132
other	Nausea	Gastrointestinal disorders	Ceftriaxone	9	135
other	Abdominal pain	Gastrointestinal disorders	MK0826	4	132
other	Abdominal pain	Gastrointestinal disorders	Ceftriaxone	8	135

1 to 10 of 356Source ClinicalTrials.gov

See all 356 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	MK0826
Total, all-cause mortality	Ceftriaxone
Total, other adverse events	MK0826	85	132
Total, other adverse events	Ceftriaxone	90	135
Total, serious adverse events	MK0826	12	132
Total, serious adverse events	Ceftriaxone	8	135

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22563210	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
MK0826 vs Ceftriaxone: Microbiological Response Assessment Profile	Trial comparisons
MK0826 vs Ceftriaxone: Clinical Response Assessment Profile	Trial comparisons
MK0826 vs Ceftriaxone: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01014013

GET https://conductscience.org/api/trials/v1/NCT01014013/events?page=2

API reference For AI assistants