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A Randomized Double-Masked Trial of Caspofungin Versus Placebo as Prophylaxis of Invasive Candidiasis in High-Risk Adults in the Critical Care Setting


Phase 3
N/A
N/A
Not Enrolling
Both
Candidiasis

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Trial Information

A Randomized Double-Masked Trial of Caspofungin Versus Placebo as Prophylaxis of Invasive Candidiasis in High-Risk Adults in the Critical Care Setting


This study is designed as a prospective, multi-center randomized double-masked
placebo-controlled trial of caspofungin versus placebo for prevention of invasive
candidiasis in high-risk adults in the critical care setting. The objective of this study
is to evaluate the efficacy of caspofungin as prophylaxis for invasive candidiasis in
high-risk ICU subjects by comparing the risk of invasive candidiasis in subjects receiving
caspofungin with the risk in those receiving placebo. The secondary objectives are to
evaluate the rate of invasive candidiasis in subjects meeting the clinical prediction rule;
to prospectively assess the effect of colonization as a risk factor for the development of
invasive candidiasis; to evaluate the safety of caspofungin as prophylaxis for invasive
candidiasis by summarizing the proportion of subjects who discontinue study therapy because
of a drug-related adverse event and the proportion of subjects with one or more drug-related
adverse event(s); and to evaluate all-cause mortality. The planned sample size will be 1200
subjects, 1/3 in the control arm and 2/3 in the active treatment arm based on a power of at
least 0.8 needed to detect a 50% reduction in incidence from base rate of 11% to 5.5%.
High-risk icu subjects greater than or equal to 18 years of age meeting all eligibility
criteria with at least 5 days of anticipated ICU stay will be randomized to receive either
caspofungin 50 mg/day (70 mg/day for subjects on rifampin) or placebo (normal saline) daily.
Caspofungin or placebo will be given intravenously as a single daily dose infused over
approximately one hour. Subjects will receive study drug or placebo for the duration on
their icu stay, up to a maximum of 28 days.

Inclusion Criteria


INCLUSION CRITERIA

Subjects who meet all of the following criteria are eligible for enrollment into the
study:

Participant, or their legal representative, has signed the informed consent. Sites will
follow their institutional review board (IRB) specific guidelines for obtaining informed
consent.

Admission to an ICU within the previous 3 days. The subject may be enrolled into this
study on Days 3, 4 or 5 of the ICU admission, and MUST HAVE an expected stay of at least 2
additional days in the ICU.

NOTE: The day the subject is admitted to the ICU is Day 1 of ICU Admission. All days are
counted in calendar days.

Non-pregnant subjects greater than or equal to 18 years of age. Subjects of childbearing
potential must have a negative serum or urine pregnancy test within 7 days prior to study
entry.

Subject must have at least 1 of the following:

Received at least one dose of any systemic antibiotic on any one of the ICU days before
study entry and continue to receive antibiotics at the time of enrollment.

Presence of a central venous catheter at time of enrollment and for 1 additional day
during current ICU stay.

And at least 2 of the following:

- Use of total parenteral nutrition on any of Days 1-4 of the ICU admission.

- Any type dialysis on any of Days 1-4 of the ICU admission.

- Any in-patient surgery, done under general anesthesia or epidural block, within the 7
days prior to or on ICU admission. (Excludes placement of vascular catheters.)

- Pancreatitis (documented by CT scan or lipase greater than 1,000 u/L) within the 7
days prior to or on ICU admission.

- More than 1 dose of systemic steroids (prednisone equivalent dose greater than or
equal to 20 mg per day) between 7 days prior to and through Day 3 of ICU admission.

- Use of more than 1 dose of other systemic immunosuppressive agents (such as
azathioprine, tacrolimus, sirolimus, mycophenolate, monoclonal antibodies, and TNF
immunomodulators) within the 7 days prior to or on ICU admission.

EXCLUSION CRITERIA

Subjects who meet any of the following criteria are ineligible for enrollment in the
study:

- Allergy or intolerance to caspofungin or any other echinocandin analog.

- Absolute neutrophil count less than 500/mm(3) at study entry or likely to develop
such an absolute neutrophil count during the study therapy period.

- A diagnosis of HIV, aplastic anemia, or chronic granulomatous disease.

- Moderate or severe hepatic insufficiency as indicated by a Child-Pugh Score of 7 or
higher or cirrhosis due to any cause (Child-Pugh scores are to be calculated only if
hepatic insufficiency is suspected.

- Women who are pregnant or breastfeeding.

- Subjects unlikely to survive more than 2 days.

- Subjects who have received a systemic antifungal agent for treatment or prophylaxis
within 7 days prior to study entry.

- Subjects with documented active, proven or probable IFI within 7 days prior to study
entry.

- Subjects who have previously participated in this study.

- Subjects who have received another investigational agent within 7 days prior to study
entry or who are currently receiving another investigational agent.

- Subjects in the ICU greater than 5 days prior to enrollment into this study.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

050057

NCT ID:

NCT00099775

Start Date:

December 2004

Completion Date:

September 2005

Related Keywords:

  • Candidiasis
  • Mycoses
  • Candida
  • Echinocandin
  • Immunocompromised Host
  • Invasive Fungal Infection
  • Fungal Infection
  • Candidiasis
  • Candidiasis, Invasive

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892