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CandidiasisPhase 3NCT00099775

Caspofungin to Prevent Candidiasis in Adults in Hospital Intensive Care Units

A Phase 3 study testing Caspofungin in people with Candidiasis, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will examine whether the anti-fungal drug caspofungin can prevent Candida infections in adult patients in intensive care units (ICUs). Caspofungin is approved to treat certain fungal infections, including fungal blood stream infections due to Candida. Read more about this study

Who is it for?
Any age
Conditions the study is for
Candidiasis
What is being tested?
Caspofungin
How many people
1,200 participants
Where
1 siteUnited States
Study dates
Dec 2004to Sep 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Cancer Institute (NCI)

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: 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 will examine whether the anti-fungal drug caspofungin can prevent Candida infections in adult patients in intensive care units (ICUs). Caspofungin is approved to treat certain fungal infections, including fungal blood stream infections due to Candida. Because ICU patients are at high risk for Candida, it would be beneficial to have a preventive drug, thereby reducing complications due to infection.

Patients 18 years of age or older who are not pregnant may be enrolled in this study on day 3 or 4 of their ICU admission if they have an expected stay of at least 2 additional days in the ICU.

Read more

Participants are randomly assigned to treatment with either caspofungin or placebo (an inactive substance). Before treatment, patients have a medical history and physical examination. Blood and urine tests are done for routine tests and to look for fungal infection. Additional samples that may be collected to test for fungal infection include a rectal swab or stool sample; a wound culture if the patient has a wound, or a sputum culture in patients who have a tube in their throat to help with breathing or are producing sputum.

Patients take caspofungin or placebo once a day for no more than 28 days. In addition, they undergo the following procedures:

  • Review of treatment side effects and medicines taken, daily during treatment, 1 week after treatment, and 2 weeks after treatment
  • Physical examination once a week, on the last day of treatment, and 1 week after treatment
  • Urine test once a week, on the last day of treatment, and 1 week after treatment to look for possible fungal infection
  • Blood tests twice a week, on the last day of treatment, 1 week after treatment, and 2 weeks after treatment for laboratory safety tests and to look for fungal infection
  • Collection of additional samples (rectal swab or stool sample, wound culture, or sputum sample) once a week, on the last day of treatment, and 1 week after treatment to look for possible fungal infection
Read the detailed description

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.

Conditions
Candidiasis
Being tested
Caspofungin
Keywords
Mycoses, Candida, Echinocandin, Immunocompromised Host, Invasive Fungal Infection, Fungal Infection
Medical subject headings
Candidiasis, Mycoses, Torulopsis, Invasive Fungal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CaspofunginDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2004 (estimated)
  2. Study startDec 2004
  3. Study completionSep 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Enrolment
1,200 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00099775
Sponsor's protocol ID
050057
Other IDs
05-C-0057
Status last verified
Sep 2005
First submitted
18 Dec 2004
Last updated
4 Mar 2008
Results posted
No

Publications

  • Mora-Duarte J, Betts R, Rotstein C, Colombo AL, Thompson-Moya L, Smietana J, Lupinacci R, Sable C, Kartsonis N, Perfect J; Caspofungin Invasive Candidiasis Study Group. Comparison of caspofungin and amphotericin B for invasive candidiasis. N Engl J Med. 2002 Dec 19;347(25):2020-9. doi: 10.1056/NEJMoa021585.

    PubMed 12490683

  • Beck-Sague C, Jarvis WR. Secular trends in the epidemiology of nosocomial fungal infections in the United States, 1980-1990. National Nosocomial Infections Surveillance System. J Infect Dis. 1993 May;167(5):1247-51. doi: 10.1093/infdis/167.5.1247.

    PubMed 8486965

  • Banerjee SN, Emori TG, Culver DH, Gaynes RP, Jarvis WR, Horan T, Edwards JR, Tolson J, Henderson T, Martone WJ. Secular trends in nosocomial primary bloodstream infections in the United States, 1980-1989. National Nosocomial Infections Surveillance System. Am J Med. 1991 Sep 16;91(3B):86S-89S. doi: 10.1016/0002-9343(91)90349-3.

    PubMed 1928197

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Caspofungin in people with Candidiasis, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00099775, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.

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