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

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: November 18, 2013
Last verified: November 2013
Results First Received: January 19, 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: Urinary Tract Infection
Interventions: Drug: ertapenem sodium (MK0826)
Drug: Comparator: ceftriaxone sodium

  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

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  
Number of Participants  
[units: participants]
  135     136     271  
Age  
[units: years]
Mean ± Standard Deviation
  55.4  ± 19.5     56.5  ± 17.6     55.9  ± 18.5  
Gender  
[units: participants]
     
Female     119     126     245  
Male     16     10     26  
Stratum [1]
[units: participants]
     
Acute pyelonephritis     103     107     210  
Other complicated urinary tract infection     32     29     61  
Duration of Symptoms(Days) [2]
[units: Days]
Mean ± Standard Deviation
  4.1  ± 4.6     4.7  ± 6.4     4.4  ± 5.6  
[1] Patients have enrolled who have complicated urinary tract infection with or without acute pyelonephritis
[2] 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


  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.


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.  


Results Point of Contact:  
Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372


No publications provided


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: November 18, 2013
Health Authority: Korea: Food and Drug Administration