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Randomized Study of Caspofungin Prophylaxis Followed by Pre-emptive Therapy for Invasive Candidiasis in the Intensive Care Unit (ICU) (MSG-01)

This study has been completed.
Sponsor:
Collaborator:
Merck
Information provided by:
Mycoses Study Group
ClinicalTrials.gov Identifier:
NCT00520234
First received: August 21, 2007
Last updated: April 8, 2011
Last verified: April 2011
History of Changes
Results First Received: March 15, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Invasive Candidiasis
Interventions: Drug: Caspofungin
Drug: Normal Saline

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Prophylaxis Caspofungin 50 mg IV daily up to 28 days of therapy
Placebo Normal Saline 100 cc IV daily

Participant Flow:   Overall Study
    Prophylaxis     Placebo  
STARTED     118     104  
COMPLETED     117     102  
NOT COMPLETED     1     2  



  Baseline Characteristics
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  Outcome Measures
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1.  Primary:   Proven and Probable Invasive Candidiasis Based on Modified Mycoses Study Group/European Organization for Research and Treatment of Cancer (MSG/EORTC) Criteria.   [ Time Frame: Within 7 days after end of therapy ]
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2.  Secondary:   Subjects Who Discontinue Study Therapy Due to a Drug-related Adverse Event   [ Time Frame: Up to 14 days after end of therapy ]
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3.  Secondary:   Subjects With 1 or More Serious Drug-related Adverse Event(s)   [ Time Frame: Up to 14 days after end of therapy ]
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4.  Secondary:   Incidence of Proven Invasive Candidiasis by MSG/ EORTC Criteria.   [ Time Frame: Within 7 days of end of therapy ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   All Cause Mortality   [ Time Frame: Within 7 days of end of therapy ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Initiation of Other Antifungals   [ Time Frame: Within 7 days after end of therapy ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Time to Development of Proven or Probable Invasive Candidiasis   [ Time Frame: Within 7 days after end of therapy ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Incidence of Proven and Probable Invasive Fungal Infections Other Than Invasive Candidiasis.   [ Time Frame: Within 7 days after end of therapy ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Time to Beta Glucan Negativity in Pre-emptive Phase.   [ Time Frame: Within 14 days after end of therapy ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   Incidence of Complete and Partial Response by Clinical and Microbiological or Serological Evidence for Subjects on the Pre-emptive Therapy Phase.   [ Time Frame: Within 14 days after end of therapy ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   Hospital Metrics (to be Evaluated Separately for Prophylaxis and Pre-emptive Therapy Phases); Length of Stay in the Hospital, Length of Stay in the ICU, and the Costs Data for the ICU Stay and the Hospitalization, if Available.   [ Time Frame: Hospital discharge ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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
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Results Point of Contact:  
Name/Title: Luis Ostrosky-Zeichner, MD
Organization: Mycoses Study Group
phone: (713) 500-6733
e-mail: Luis.Ostrosky-Zeichner@uth.tmc.edu


Publications:


Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT00520234     History of Changes
Other Study ID Numbers: MSG-01
Study First Received: August 21, 2007
Results First Received: March 15, 2011
Last Updated: April 8, 2011
Health Authority: United States: Institutional Review Board