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NCT Number: NCT00520234

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

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.

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Key information

Conditions

Invasive Candidiasis Bacterial Infections and Mycoses Candidiasis Candidiasis, Invasive Infections Invasive Fungal Infections Mycoses Torulopsis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Caspofungin

Drug

50 mg IV daily

normal saline

Drug

100 cc IV daily

Other names: placebo

Primary outcomes

  1. 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

    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 outcomes

  1. Incidence of Proven Invasive Candidiasis by MSG/ EORTC Criteria.

    Time frame: Within 7 days of end of therapy

  2. All Cause Mortality

    Time frame: Within 7 days of end of therapy

  3. Initiation of Other Antifungals

    Time frame: Within 7 days after end of therapy

  4. Time to Development of Proven or Probable Invasive Candidiasis

    Time frame: Within 7 days after end of therapy

  5. Incidence of Proven and Probable Invasive Fungal Infections Other Than Invasive Candidiasis.

    Time frame: Within 7 days after end of therapy

  6. Time to Beta Glucan Negativity in Pre-emptive Phase.

    Time frame: Within 14 days after end of therapy

  7. 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

  8. 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

  9. Subjects Who Discontinue Study Therapy Due to a Drug-related Adverse Event

    Time frame: Up to 14 days after end of therapy

  10. Subjects With 1 or More Serious Drug-related Adverse Event(s)

    Time frame: Up to 14 days after end of therapy

Sponsors and collaborators

Lead sponsor

Mycoses Study Group

Network

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study 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

Acronym: MSG-01

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Aug 23, 2007
Registry last updated
May 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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