Page Nct des essais cliniques

Summary
EudraCT Number:2004-000424-32
Sponsor's Protocol Code Number:045
National Competent Authority:Belgium - FPS Health-DGM
Clinical Trial Type:EEA CTA
Trial Status:Completed
Date on which this record was first entered in the EudraCT database:2004-07-08
Trial results View results
Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL
A. Protocol Information
A.1Member State ConcernedBelgium - FPS Health-DGM
A.2EudraCT number2004-000424-32
A.3Full title of the trial
A Multicenter, Open, Noncomparative Study to Estimate the Safety, Tolerability, and Efficacy of Caspofungin Acetate in the Treatment of Adults with Invasive Candida Infections (Excluding Patients with Candidemia As the Sole Site of Infection).
A.3.2Name or abbreviated title of the trial where available
Caspofungin for the Treatment of Non-blood Candida Infections
A.4.1Sponsor's protocol code number045
A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorMerck Sharp & Dohme BV
B.1.3.4CountryBelgium
B.3.1 and B.3.2Status of the sponsorCommercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing support
B.4.2Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisation
B.5.2Functional name of contact point
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
D.2.1.1.1Trade name CANCIDAS
D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme
D.2.1.2Country which granted the Marketing AuthorisationBelgium
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameCaspofungin for Injection
D.3.2Product code MK-0991
D.3.4Pharmaceutical form Injection*
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product Information not present in EudraCT
D.3.11.8Extractive medicinal product Information not present in EudraCT
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product Information not present in EudraCT
D.8 Information on Placebo
D.8 Placebo: 1
D.8.1Is a Placebo used in this Trial?Yes
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Non-Blood Invasive Candidiasis
MedDRA Classification
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main 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.
E.2.2Secondary 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.
E.2.3Trial contains a sub-study Information not present in EudraCT
E.3Principal 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.
E.4Principal 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.
E.5 End points
E.5.1Primary 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.
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy Yes
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic Yes
E.6.7Pharmacodynamic No
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic Information not present in EudraCT
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other Yes
E.7.1.3.1Other trial type description
Estimation study to obtain additional safety and efficacy data for caspofungin in the treatment of p
E.7.2Therapeutic exploratory (Phase II) Yes
E.7.3Therapeutic confirmatory (Phase III) No
E.7.4Therapeutic use (Phase IV) No
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised No
E.8.1.2Open Yes
E.8.1.3Single blind No
E.8.1.4Double blind No
E.8.1.5Parallel group No
E.8.1.6Cross over No
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) No
E.8.2.2Placebo No
E.8.2.3Other 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.8.5The trial involves multiple Member States No
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA Yes
E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
E.8.7Trial 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
Recruitment in the study will be approximately 24 months, with each patient expected to complete the study, including follow-up, within approximately 6 months.
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years2
E.8.9.1In the Member State concerned months6
E.8.9.1In the Member State concerned days
E.8.9.2In all countries concerned by the trial years2
E.8.9.2In all countries concerned by the trial months6
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero Information not present in EudraCT
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
F.1.1.3Newborns (0-27 days) Information not present in EudraCT
F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
F.1.1.5Children (2-11years) Information not present in EudraCT
F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
F.1.2Adults (18-64 years) Yes
F.1.3Elderly (>=65 years) Yes
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Information not present in EudraCT
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state4
F.4.2 For a multinational trial
F.4.2.1In the EEA 10
F.4.2.2In the whole clinical trial 50
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2004-09-23
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2004-07-27
P. End of Trial
P.End of Trial StatusCompleted
P.Date of the global end of the trial2006-02-10

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