A Phase III, Double Blind, Randomized, Multi-Center Study of the Safety and Efficacy of Anidulafungin VS. Fluconazole in the Treatment of Patients With Candidemia and Other Forms of Invasive Candidiasis and Prevention of Complications
Diagnosis of candidemia or other forms of invasive candidiasis from a blood culture or a
culture specimen from a normally sterile site, the sample preferably having been taken
within 96 hours before study entry. The diagnosis will be based on the following:
1. Candidemia: at least one blood culture positive for yeast (in the absence of other
demonstrated foci of infection).
2. Other Forms of Invasive Candidiasis:
- Positive culture for yeast from a specimen from a normally sterile site with or
without a positive blood culture;
- Positive yeast culture from a newly-placed drain in a normally sterile site; or
- Any positive blood culture for yeast plus ophthalmic examination consistent with
Candida endophthalmitis (patients with mycological documentation of Candida
endophthalmitis with negative blood cultures will be included).
- Positive yeast cultures from urine or sputum do NOT qualify as a positive
3. AND at least one of the following signs and symptoms:
- A fever defined as an oral temperature of 100.4° (Degree) F (38.0° (Degree)C) or
greater, rectal temperature of 101.4° (Degree) F (38.4° (Degree)C) or greater,
or an axillary temperature of 99.4° (Degree) F (37° (Degree)C) or greater.
Hypothermia defined as a temperature less than 96.8° (Degree) F (36.0°
- A systolic blood pressure of less than 100 mmHg or a decrease in systolic blood
pressure of at least 30 mmHg from patient's normal systolic blood pressure.
- Some sign of inflammation (swelling, heat, erythema, purulence, or drainage from
a wound) at a site positive for Candida
- Signs or symptoms of candidemia/invasive candidiasis.
4. Radiological findings of invasive candidiasis.
5. Male or female 16 years of age or older.
6. Willing and able to give signed informed consent, or have a legally authorized
representative who is willing and able to give consent. Informed assent will be
required for children less than 18 years of age.
7. Reliable and willing to make themselves available for the duration of the study and
to abide by the study restrictions.
8. Expected hospitalization of at least 3 days.
1. Female patients who are pregnant, lactating (breast feeding) or planning a pregnancy
during the course of the study, or who are of child bearing potential and not using
an acceptable method of birth control (i.e. abstinence, surgically sterile,
intrauterine device, oral contraceptive plus barrier contraceptive, hormone delivery
system plus barrier contraceptive or condom in combination with contraceptive cream,
jelly or foam). Patients are to continue contraceptive methods during the study and
for at least 30 days after receiving their last treatment.
2. Patients who have received greater than 72 hours of systemic antifungal therapy for
the Candida infection for which they will be enrolled (patients who develop their
Candida infection while receiving caspofungin or azole therapy will also be
3. Patients who have received prophylactic administration of fluconazole, itraconzaole,
or voriconazole greater than or equal to one week within 30 days prior to enrollment.
4. Patients who have failed antifungal therapy with any systemic antifungal for this
episode of candidiasis/candidemia. Recurrence within 2 weeks is considered failure
of previous therapy.
5. Patients with suspected Candida osteomyelitis, endocarditis, or meningitis.
6. Patients with prosthetic devices which are a suspected site of infection are excluded
unless the device is removed at study entry or soon after randomization.
[Hemodialysis shunts (AV fistulae) may reamin in situ].
7. Patients with prosthetic heart valves or vascular grafts suspected to be the site of
the candida infection and positive blood cultures.
8. Patients receiving and who will continue to receive terfenadine, cisapride,
dofetilide, quinidine, pimozide and rifampin.
9. Patients who have, at any time, previously received anidulafungin.
10. Known Candida krusei infection.
11. Patients requiring continued treatment with another systemic antifungal agent [oral
non-absorbable azoles (e.g., clotrimazole troches) are permitted].
12. Patients with a known hypersensitivity to echinocandin therapy or azole therapy.
13. Patients with any of the following abnormal laboratory values:
1. bilirubin greater than 5 times theULN
2. AST or ALT greater than 5 times theULN
14. Patients with poor venous access that would preclude intravenous drug delivery or
multiple blood draws.
15. Patients who have participated in a study of an investigational drug or device
(without any FDA approved indications) within four weeks of study entry. The
investigational use of antiretroviral agents and the investigational use of licensed
agents is permitted if the patient is on a stable regimen for four weeks prior to
16. Life expectancy less than 72 hours.
17. Patients on hemodialysis unable to tolerate the volume of IV fluid on non-dialysis