E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non-Blood Invasive Candidiasis |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To estimate in caspofungin-treated patients with non-blood sites of invasive candidiasis the favourable overall response rate (both clinical and microbiological) at the end of caspofungin therapy. |
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E.2.2 | Secondary objectives of the trial |
To estimate in caspofungin-treated patients with non-blood sites of invasive candidiasis, a) The favourable overall response rate (both clinical and microbiological) on day 10 of caspofungin therapy. b) The favourable overall response rate (both clinical and microbiological) at the end of all antifungal therapy (caspofungin and/or subsequent oral fluconazole). c) The occurrence of relapse during the 12 week follow-up period following the completion of all antifungal therapy in those patients successfully treated with caspofungin.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. The patient must have at least 1 positive culture for Candida species obtained from an otherwise sterile, non-blood body site within the 4 days prior to study entry. 2. 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: a. Oral temperature > 37.8ºC on 2 occasions at least 4 hours apart, or 1 temperature determination > 38.3ºC , or clinically significant hypothermia < 36.0ºC. b. Systolic blood pressure <90, or a 30 mmHg decrease in systolic blood pressure from the patients normal baseline c. Signs of inflammation from a site infected with Candida.
3. The patient is an adult at least 18 years of age. 4. For women of childbearing potential, the patient must have a negative serum or urine pregnancy test sensitive to 25 IU HCG prior to enrollment into the study.
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E.4 | Principal exclusion criteria |
1. The patient has Candida disease limited to the oropharynx, esophagus, or other mucosal or superficial skin surfaces. 2. The patient has Candida disease limited to the bloodstream. 3. The patient has evidence of infection limited to a positive culture for Candida spp. from sputum, broncho-alveolar lavage, catheter tip, or indwelling catheters/drains. 4. The patient has evidence of infection limited to a positive culture for Candida spp. from the urine without signs and symptoms of upper tract disease. 5. The patient has a prosthetic device at a suspected site of Candida infection. (NOTE: patients may be eligible for enrolment if the device is surgically removed at study entry or within 72 hours after randomization). 6. The patient has the following abnormal laboratory values: a. INR >1.6 (if patients receiving anticoagulation INR >4.0) b. Serum total bilirubin >5 times the upper limit of normal. c. Serum AST (SGOT) or ALT (SGPT) >5 times the upper limit of normal. d. Serum Alkaline Phosphatase >5 times the upper limit of normal 7. The patient has a history of allergy, hypersensitivity, or any serious reaction to caspofungin or another member of the echinocandin class. 8. The patient has received caspofungin or another member of the echinocandin class at any time during the 7 days prior to enrolment.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint will be to display the proportion of caspofungin-treated patients with a favourable overall clinical response and favourable overall microbiological response at the end of caspofungin therapy. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
Estimation study to obtain additional safety and efficacy data for caspofungin in the treatment of p |
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E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Recruitment in the study will be approximately 24 months, with each patient expected to complete the study, including follow-up, within approximately 6 months. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |