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

Invasive Candidiasis Clinical Trial

— MSG-01  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00520234
• Other study ID #: MSG-01
• Status: Completed
• Phase: Phase 4
• First received: August 21, 2007
• Last updated: April 8, 2011
• Start date: August 2007
• Est. completion date: March 2010

Study information

• Verified date: April 2011
• Source: Mycoses Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Invasive
• Invasive Candidiasis

Intervention

Drug:
• Caspofungin
50 mg IV daily
• Normal Saline
100 cc IV daily

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Cooper University Hospital	Camden	New Jersey
United States	Medical Center of South Carolina	Charleston	South Carolina
United States	The Ohio State University	Columbus	Ohio
United States	University of Colorado	Denver	Colorado
United States	Harper University Hospital/ Wayne State	Detroit	Michigan
United States	Henry Ford Hospital	Detroit	Michigan
United States	University of Southern California	Los Angeles	California
United States	St. Patrick's Hospital	Missoula	Montana
United States	Tulane University	New Orleans	Louisiana
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Mycoses Study Group	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

References & Publications (4)

Denning DW. Echinocandins: a new class of antifungal. J Antimicrob Chemother. 2002 Jun;49(6):889-91. Review. — View Citation

Diekema DJ, Messer SA, Brueggemann AB, Coffman SL, Doern GV, Herwaldt LA, Pfaller MA. Epidemiology of candidemia: 3-year results from the emerging infections and the epidemiology of Iowa organisms study. J Clin Microbiol. 2002 Apr;40(4):1298-302. — View Citation

Goodman JL, Winston DJ, Greenfield RA, Chandrasekar PH, Fox B, Kaizer H, Shadduck RK, Shea TC, Stiff P, Friedman DJ, et al. A controlled trial of fluconazole to prevent fungal infections in patients undergoing bone marrow transplantation. N Engl J Med. 1992 Mar 26;326(13):845-51. — View Citation

Jarvis WR. Epidemiology of nosocomial fungal infections, with emphasis on Candida species. Clin Infect Dis. 1995 Jun;20(6):1526-30. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proven and Probable Invasive Candidiasis Based on Modified Mycoses Study Group/European Organization for Research and Treatment of Cancer (MSG/EORTC) Criteria.	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.	Within 7 days after end of therapy	No
Secondary	Incidence of Proven Invasive Candidiasis by MSG/ EORTC Criteria.		Within 7 days of end of therapy	No
Secondary	All Cause Mortality		Within 7 days of end of therapy	No
Secondary	Initiation of Other Antifungals		Within 7 days after end of therapy	No
Secondary	Time to Development of Proven or Probable Invasive Candidiasis		Within 7 days after end of therapy	No
Secondary	Incidence of Proven and Probable Invasive Fungal Infections Other Than Invasive Candidiasis.		Within 7 days after end of therapy	No
Secondary	Time to Beta Glucan Negativity in Pre-emptive Phase.		Within 14 days after end of therapy	No
Secondary	Incidence of Complete and Partial Response by Clinical and Microbiological or Serological Evidence for Subjects on the Pre-emptive Therapy Phase.		Within 14 days after end of therapy	No
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.		Hospital discharge	No
Secondary	Subjects Who Discontinue Study Therapy Due to a Drug-related Adverse Event		Up to 14 days after end of therapy	Yes
Secondary	Subjects With 1 or More Serious Drug-related Adverse Event(s)		Up to 14 days after end of therapy	Yes