Janice Brown
Phase III of 2 Dosing Regimens of Caspofungin in the Treatment of Invasive Candidiasis in Adults
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
To compare in patients receiving caspofungin 50 mg daily (following a 70 mg loading dose on Day 1) versus caspofungin 150 mg daily for the treatment of invasive candidiasis, (1) the proportion of patients developing significant drug-related adverse experiences (serious drug-related adverse experiences or drug-related adverse experiences leading to caspofungin discontinuation) while on caspofungin study therapy or during the immediate 14-day post-caspofungin therapy period.
Recruiting Status:
CompletedStanford Recruiting Status:
CompletedCondition(s):
Intervention(s):
- Drug: Caspofungin
Phase:
Phase 3Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
a. The patient must have at least one positive culture of a Candida species obtained from blood or other normally-sterile, invasive site within 4 days prior to study entry (NOTE: Sites of Candida infection that are eligible for enrollment, including specific diagnostic criteria required for each of these sites, are outlined in Appendix 2).
b. The patient must also have clinical evidence of Candida infection, including at least one of the following within the 4 days prior to study entry:
1) temperature >100?F (37.8?C) on two occasions at least 4 hours apart, or one temperature determination >101?F (38.3?C), or clinically significant hypothermia <96.8?F (36.0?C);
2) systolic blood pressure <90 mm Hg, or a ≥30 mm Hg decrease in systolic blood pressure from the patient?s normal baseline;
3) signs of inflammation (e.g., swelling, heat, erythema, pain/tenderness, purulent drainage) from a site infected with Candida (e.g., abscess site, skin, eye).
c. Patient is an adult at least 18 years of age.
d. For women of childbearing potential, the patient has a negative serum or urine pregnancy test sensitive to 25 IU HCG prior to enrollment into the study. Subsequently, the patient agrees to use adequate birth control measures as defined by the investigator. (NOTE: Oral contraceptives should not be used as the sole method of birth control because the effect of caspofungin on the efficacy of oral contraceptives has not yet been established).
Key Exclusion Criteria:
a. The patient has Candida disease limited to the oropharynx, esophagus, or other mucosal or superficial skin surfaces (e.g., vagina or other genitalia, colonic tract, skin folds, nail beds, etc.).
b. The patient has evidence of infection limited to a positive culture for Candida spp. from the sputum, broncho-alveolar lavage (BAL), catheter tip, or indwelling catheters/drains (NOTE: Culture samples obtained at the time of the sterile placement of a non-vascular catheter or drain are eligible).
c. The patient has evidence of infection limited to a positive culture for Candida spp. from the urine (NOTE: Patients with a positive urine culture who have signs and symptoms of upper tract disease [e.g., fever with flank pain, evidence of WBC casts in urine] remain eligible for enrollment.)
d. The patient has suspected Candida endocarditis, osteomyelitis, or meningitis.
e. The patient has a prosthetic device at a suspected site of Candida infection (NOTE: Patients may be eligible for enrollment if the device is surgically removed at study entry or within 72 hours after randomization).
f. The patient has one of the following abnormal laboratory values:
1) INR >1.6 (if patients are receiving anticoagulation, then INR >4.0).
2) Serum total bilirubin >5 times upper limit of normal.
3) Serum AST (SGOT) or ALT (SGPT) >5 times the upper limit of normal.
g. The patient has a history of allergy, hypersensitivity, or any serious reaction to caspofungin or another member of the echinocandin class (e.g., micafungin, anidulafungin).
h. The patient has received another member of the echinocandin class (e.g., micafungin, anidulafungin) at any time during the 7 days prior to enrollment in the study.
i. The patient received more than a total dose of 70mg caspofungin, 1600 mg fluconazole, 1200 mg voriconazole, 800 mg itraconazole, 2 mg/kg amphotericin B deoxycholate, OR 10 mg/kg of a lipid formulation of amphotericin B since the original positive Candida culture was obtained (antifungal prophylaxis prior to initial positive culture is permitted with a non?echinocandin agent).
j. The patient has failed antifungal therapy with any systemic (i.e., oral or IV) antifungal agent for this episode of invasive candidiasis. Recurrence within 2 weeks is considered failure of previous antifungal therapy.
k. The patient is not expected to survive at least 5 days.
l. A female patient is pregnant or breast feeding.
m. The patient has a diagnosis of acute hepatitis, moderate or severe hepatic insufficiency (Child Pugh score >6, see Appendix 3), or cirrhosis due to any cause.
n. The patient has participated in another clinical study involving the administration of an investigational drug within 14 days of presentation or during the course of the study (NOTE: Patients who received an investigational antifungal therapy within 14 days prior to study entry may
eligible for enrollment, provided the investigational agent was not an echinocandin).
o. The patient has previously participated in this study at any time in the past.
p. The patient has any condition or concomitant illness which, in the opinion of the investigator, might confuse the results of the study or pose additional risk in administering the study drugs to the patient.
q. The patient will be receiving rifampin, cyclosporin A, or other systemic (i.e., IV or oral) antifungal therapy while on caspofungin study therapy.
Additional Study Details
Official Title:
A Multicenter, Randomized, Double-Blind, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of 2 Dosing Regimens of Caspofungin in the Treatment of Invasive Candidiasis in Adults: Protocol/Amendment No.: 801-00Anticipated start date:
4/24/2006Lead Sponsor:
Merck & CoInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
Cross OverEndpoints:
Safety/EfficacyPrimary Outcomes:
- Evaluate the safety of standard (50mg) versus a higher dose(150mg) of MK0991 in patients treated for invasive candidiasis, by the proportion of patients who develop significant drug related adverse events.
Secondary Outcomes:
- Comparison of the proportion of patients with a favorable clinical and microbiological response at the end of treatment with either standard dosing (50mg) or higher doses (150mg) if Caspofungin
Total Number to be Enrolled:
200Total Number to be Enrolled at Stanford:
6More Information
Secondary ID(s):
- 801-00
- 96807
- BMT181
- NCT00250432
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
4/20/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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