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:
Mycoses Study Group
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
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Purpose
Adults admitted to intensive care units are at risk for a variety of complications. Infections due to the fungus called candida are of particular concern. The study will test the possibility that caspofungin, a new therapy for fungal infections, can successfully reduce the rate of candida infections in subjects at risk. It will also test if caspofungin is useful in treating subjects for this disease when diagnosed using a new blood test that is performed twice weekly, permitting earlier diagnosis than current practice standards.
| Condition | Intervention | Phase |
|---|---|---|
|
Invasive Candidiasis |
Drug: Caspofungin Drug: Normal Saline |
Phase 4 |
| 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 |
| Official Title: | A Randomized, Double-blind, Placebo Controlled Trial of Caspofungin Prophylaxis Followed by Pre-emptive Therapy for Invasive Candidiasis in High-risk Adults in the Critical Care Setting |
Resource links provided by NLM:
Further study details as provided by Mycoses Study Group:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]Modified MSG/EORTC criteria for the diagnosis of fungal infections: Proven invasive candidiasis is defined as candidemia, Candida cultured from a sterile site, or histopathological evidence of candida infection. Probable invasive candidiasis is defined as 2 consecutive positive beta glucan levels in the presence of signs and symptoms of infection.
Secondary Outcome Measures:
- Incidence of Proven Invasive Candidiasis by MSG/ EORTC Criteria. [ Time Frame: Within 7 days of end of therapy ] [ Designated as safety issue: No ]
- All Cause Mortality [ Time Frame: Within 7 days of end of therapy ] [ Designated as safety issue: No ]
- Initiation of Other Antifungals [ Time Frame: Within 7 days after end of therapy ] [ Designated as safety issue: No ]
- Time to Development of Proven or Probable Invasive Candidiasis [ Time Frame: Within 7 days after end of therapy ] [ Designated as safety issue: No ]
- Incidence of Proven and Probable Invasive Fungal Infections Other Than Invasive Candidiasis. [ Time Frame: Within 7 days after end of therapy ] [ Designated as safety issue: No ]
- Time to Beta Glucan Negativity in Pre-emptive Phase. [ Time Frame: Within 14 days after end of therapy ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Subjects Who Discontinue Study Therapy Due to a Drug-related Adverse Event [ Time Frame: Up to 14 days after end of therapy ] [ Designated as safety issue: Yes ]
- Subjects With 1 or More Serious Drug-related Adverse Event(s) [ Time Frame: Up to 14 days after end of therapy ] [ Designated as safety issue: Yes ]
| Enrollment: | 222 |
| Study Start Date: | August 2007 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1 prophylaxis
Caspofungin 50 mg Intravenous (IV) daily up to 28 days of therapy
|
Drug: Caspofungin
50 mg IV daily
Other Name: caspofungin
|
|
Placebo Comparator: 2 placebo
Normal Saline 100 cc IV daily
|
Drug: Normal Saline
100 cc IV daily
Other Name: placebo
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Non-pregnant >18 yrs of age
- Subjects admitted to ICU during the preceding 3 days and expected to stay in the ICU for at least another 48 hours.Subjects can be enrolled on days 3-5 of ICU admission.
- Subjects meeting the clinical prediction rule
Exclusion Criteria:
- Subjects with an allergy/intolerance to caspofungin or echinocandin analog
- absolute neutrophil count <500/mm3 at study entry or likely to develop such a count during therapy
- acquired immunodeficiency syndrome, aplastic anemia or chronic granulomatous disease
- moderate or severe hepatic insufficiency
- subjects who are pregnant or lactating
- unlikely to survive < 24 hours
- subjects who have received systemic antifungal therapy within 10 days prior to study entry
- Documented active proven or probable invasive fungal infection upon enrollment
- previously enrolled in this study
- Currently on another investigational agent or have received an investigational agent within 10 days prior to study entry.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00520234
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35124 | |
| United States, California | |
| University of Southern California | |
| Los Angeles, California, United States, 29425 | |
| United States, Colorado | |
| University of Colorado | |
| Denver, Colorado, United States, 80262 | |
| United States, District of Columbia | |
| Washington Hospital Center | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Louisiana | |
| Tulane University | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Michigan | |
| Harper University Hospital/ Wayne State | |
| Detroit, Michigan, United States, 48201 | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| United States, Montana | |
| St. Patrick's Hospital | |
| Missoula, Montana, United States, 59802 | |
| United States, New Jersey | |
| Cooper University Hospital | |
| Camden, New Jersey, United States, 08103 | |
| United States, Ohio | |
| The Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, South Carolina | |
| Medical Center of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
Sponsors and Collaborators
Mycoses Study Group
Merck
Investigators
| Principal Investigator: | Luis Ostrosky-Zeichner, MD | The University of Texas Health Science Center, Houston |
| Principal Investigator: | Peter G Pappas, MD | Mycoses Study Group |
More Information
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 |
Keywords provided by Mycoses Study Group:
|
Candida Prophylaxis High risk adults Intensive care unit (ICU) |
Additional relevant MeSH terms:
|
Candidiasis Candidiasis, Invasive Mycoses Caspofungin Echinocandins |
Antifungal Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013