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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01014013
First received: November 12, 2009
Last updated: February 16, 2017
Last verified: February 2017
Results First Received: January 19, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator;   Primary Purpose: Treatment
Condition: Urinary Tract Infection
Interventions: Drug: ertapenem sodium (MK0826)
Drug: Comparator: ceftriaxone sodium

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Patients were recruited from 9 Medical Centers of Korea between April 2008 and January 2009.

Last patient has visited on 27 Feb 2009.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1 patient was excluded due to ineligibility. The patient had a positive at screening pregnancy test.

Reporting Groups
  Description
MK0826 A single daily dose of MK0826 1.0 g intravenous infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin at a dose of 500 mg twice daily after 3 doses of parentheral therapy)
Ceftriaxone A single daily dose of 2.0 g Ceftriaxone sodium intravenous infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin at a dose of 500 mg twice daily after 3 doses of parentheral therapy)

Participant Flow:   Overall Study
    MK0826   Ceftriaxone
STARTED   135   136 
Adverse Event Reporting   132 [1]   135 [2] 
Completed Parenteral Therapy   87 [3]   88 [4] 
COMPLETED   84 [5]   80 [6] 
NOT COMPLETED   51   56 
Inclusion/Exclusion criteria not met                1                3 
Clinical adverse experience                4                2 
Laboratory adverse experience                1                1 
Protocol Violation                1                3 
Withdrawal by Subject                7                4 
Clinical/microbiologic failure                1                2 
Pathogen culture = no growth                26                34 
Negative urine culture                2                0 
Pathogen resistant                7                4 
Physician Decision                0                1 
Another antibiotic therapy required                0                1 
Appendectomy                1                0 
Inappropriate therapy duration, < 7 Days                0                1 
[1] Patients who received at least 1 dose of MK0826 parenteral therapy
[2] Patients who received at least 1 dose of Ceftriaxone parenteral therapy
[3]

Patients completing MK0826 as a single daily dose of 1.0g intravenous

infusion at least 3 days

[4] Patients completing Ceftriaxone as a single daily dose of 2.0g intravenous infusion at least 3 days
[5] Patients who completed 7 days therapy including minimum 3 days of MK0826 parentheral therapy
[6] Patients who completed 7 days therapy including minimum 3 days of Ceftriaxone parentheral therapy



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
MK0826 A single daily dose of MK0826 1.0 g intravenous infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin at a dose of 500 mg twice daily after 3 doses of parentheral therapy)
Ceftriaxone A single daily dose of 2.0 g Ceftriaxone sodium intravenous infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin at a dose of 500 mg twice daily after 3 doses of parentheral therapy)
Total Total of all reporting groups

Baseline Measures
   MK0826   Ceftriaxone   Total 
Overall Participants Analyzed 
[Units: Participants]
 135   136   271 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.4  (19.5)   56.5  (17.6)   55.9  (18.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      119  88.1%      126  92.6%      245  90.4% 
Male      16  11.9%      10   7.4%      26   9.6% 
Stratum [1] 
[Units: Participants]
     
Acute pyelonephritis   103   107   210 
Other complicated urinary tract infection   32   29   61 
[1] Patients have enrolled who have complicated urinary tract infection with or without acute pyelonephritis
Duration of Symptoms(Days) [1] 
[Units: Days]
Mean (Standard Deviation)
 4.1  (4.6)   4.7  (6.4)   4.4  (5.6) 
[1] The duration of clinical symptoms prior to study entry


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Microbiological Response Assessment Profile   [ Time Frame: 5 to 9 days post-therapy ]

2.  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   [ Time Frame: 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 ]

3.  Secondary:   Clinical Response Assessment Profile   [ Time Frame: 5 to 9 days post-therapy ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  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:
unchecked 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.
unchecked 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.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01014013     History of Changes
Other Study ID Numbers: 0826-055
MK0826-055
2009_690
Study First Received: November 12, 2009
Results First Received: January 19, 2010
Last Updated: February 16, 2017