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Clinical trials for Amphotericin B

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44349   clinical trials with a EudraCT protocol, of which   7376   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
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    Query did not match any clinical trials.
    These are paediatric studies completed by 26 January 2007, in respect of products authorised in the Community (Article 45 of the Paediatric Regulation (EC) No 1901/2006).
    Note: Advanced search filters for country, trial phase, gender, rare disease, IMP with orphan designation in the indication and age ranges of in-utero, adult or elderly do not apply to these records.
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    Study title: "Alternative therapeutic options for neonatal candidiasis" M. Wilinska, I. Maruniak-Chudek, E.Musialik-Swietlinska, J.Swietlinski J.Ped. Neonatal, 2005; 2(1): CR14-17 "Alternative therapeutic options for neonatal candidiasis" M. Wilinska, I. Maruniak-Chudek, E.Musialik-Swietlinska, J.Swietlinski J.Ped. Neonatal, 2005; 2(1): CR14-17
    Active substance: AMPHOTERICIN B
    Study summary document link (including results):
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    Document reference: 46638
    Study title: “Amphotericin B colloidal dispersion therapy for invasive Mycosis: Report of successful therapy in two pediatrc patients” M.M.Mustafa, E.S.Sandler, J.C.Bernini, V.M. Aquino The pediatric infectious Disease Journal Vol.13, No 4, April 1994“Amphotericin B colloidal dispersion therapy for invasive Mycosis: Report of successful therapy in two pediatrc patients” M.M.Mustafa, E.S.Sandler, J.C.Bernini, V.M. Aquino The pediatric infectious Disease Journal Vol.13, No 4, April 1994
    Active substance: AMPHOTERICIN B
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    Document reference: 46639
    Study title: SAFETY AND EFFICACY OF FLUCONAZOLE PO VS. AMPHOTERICIN B SUSPENSION IN PREVENTION OF CANDIDIASIS IN LEUKEMIC PATIENTS UNDERGOING CHEMOTHERAPY.
    Active substance: FLUCONAZOLE
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    Document reference: 27598
    Study title: MULTI-CENTER EVALUATION OF FLUCONAZOLE (UK-49,858) AS TREATMENT FOR ACUTE CRYPTOCOCCAL MENINGITIS IN PATIENTS WHO HAVE FAILED TO RESPOND OR HAVE EXPERIENCED UNACCEPTABLE TOXICITY DURING TREATMENT WITH AMPHOTERICIN B
    Active substance: FLUCONAZOLE
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    Document reference: 27348
    Study title: MULTI-CENTER EVALUATION OF FLUCONAZOLE (UK-49,858) AS TREATMENT FOR ACUTE CRYPTOCOCCAL MENINGITIS IN PATIENTS WHO HAVE FAILED TO RESPOND OR HAVE EXPERIENCED UNACCEPTABLE TOXICITY DURING TREATMENT WITH AMPHOTERICIN B
    Active substance: FLUCONAZOLE
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    Document reference: 27714
    Study title: MULTICENTER STUDY COMPARING TRIFLUCANO AND AMPHOTERICIN BO (ORAL SUSPENSION) IN THE TREATMENT OF OROPHARYNGEAL CANDIDIASIS IN HIV & PATIENTS
    Active substance: FLUCONAZOLE
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    Document reference: 27456
    Study title: MULTICENTER STUDY COMPARING TRIFLUCANO AND AMPHOTERICIN BO (ORAL SUSPENSION) IN THE TREATMENT OF OROPHARYNGEAL CANDIDIASIS IN HIV & PATIENTS
    Active substance: FLUCONAZOLE
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    Document reference: 27820
    Study title: MULTICENTER, COMPARATIVE STUDY OF FLUCONAZOLE AND AMPHOTERICIN B ADMINISTERED AS ORAL SUSPENSION IN THE TREATMENT OF OROPHARYNGEAL CANDIDIASIS IN BLOOD CANCER PATIENTS.
    Active substance: FLUCONAZOLE
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    Document reference: 27455
    Study title: MULTICENTER, COMPARATIVE STUDY OF FLUCONAZOLE AND AMPHOTERICIN B ADMINISTERED AS ORAL SUSPENSION IN THE TREATMENT OF OROPHARYNGEAL CANDIDIASIS IN BLOOD CANCER PATIENTS.
    Active substance: FLUCONAZOLE
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    Document reference: 27819
    Study title: OPEN - LABEL, COMPARATIVE, RANDOMISED, MULTICENTRE STUDY OF THE EFFICACY AND SAFETY OF THE EFFICACY AND SAFETY OF FLUCONAZOLE ORAL SUSPENSION COMPARED WITH AMPHOTERICIN B ORAL SUSPENSION IN THE TREATMENT OF MUCITIS IN CANCER PATIENTS.
    Active substance: FLUCONAZOLE
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    Document reference: 27457
    Study title: OPEN - LABEL, COMPARATIVE, RANDOMISED, MULTICENTRE STUDY OF THE EFFICACY AND SAFETY OF THE EFFICACY AND SAFETY OF FLUCONAZOLE ORAL SUSPENSION COMPARED WITH AMPHOTERICIN B ORAL SUSPENSION IN THE TREATMENT OF MUCITIS IN CANCER PATIENTS.
    Active substance: FLUCONAZOLE
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    Document reference: 27821
    Study title: CLINICAL AND MICROBIOLOGICAL EFFICACY OF FLUCONAZOLE IN THE TREATMENT OF NEONATAL CANDIDA INFECTIONS: AN OPEN, COMPARATIVE, RANDOMIZATION, MULTICENTER STUDY COMPARING FLUCONAZOLE VS. AMPHOTERICIN B IV TO EVALUATE THE EFFICACY SAFETY AND OVER-ALL CONVENIENCE OF BOTH THERAPIES
    Active substance: FLUCONAZOLE
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    Document reference: 27587
    Study title: CLINICAL AND MICROBIOLOGICAL EFFICACY OF FLUCONAZOLE IN THE TREATMENT OF NEONATAL CANDIDA INFECTIONS: AN OPEN, COMPARATIVE, RANDOMIZATION, MULTICENTER STUDY COMPARING FLUCONAZOLE VS. AMPHOTERICIN B IV TO EVALUATE THE EFFICACY SAFETY AND OVER-ALL CONVENIENCE OF BOTH THERAPIES
    Active substance: FLUCONAZOLE
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    Document reference: 27950
    Study title: FLUCONAZOLE VERSUS AMPHOTERICIN B AS EMPIRICAL ANTIFUNGAL THERAPY FOR NEUTROPENIC PATIENTS.
    Active substance: FLUCONAZOLE
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    Document reference: 27695
    Study title: FLUCONAZOLE VERSUS AMPHOTERICIN B AS EMPIRICAL ANTIFUNGAL THERAPY FOR NEUTROPENIC PATIENTS.
    Active substance: FLUCONAZOLE
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    Document reference: 28057
    Study title: FLUCONAZOLE VS. AMPHOTERICIN B AS EMPIRICAL TREATMENT OF FEVER OF UNKNOWN ORIGIN
    Active substance: FLUCONAZOLE
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    Document reference: 27462
    Study title: FLUCONAZOLE VS. AMPHOTERICIN B AS EMPIRICAL TREATMENT OF FEVER OF UNKNOWN ORIGIN
    Active substance: FLUCONAZOLE
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    Document reference: 27826
    Study title: FLUCONAZOLE VS. AMPHOTERICIN B: A PROSPECTIVE, RANDOMIZED, MULTICENTER STUDY FOR THERAPY OF FUNGAL INFECTION. (ORIGINATED AT CENTRAL RESEARCH UNDER STUDY NO. 056-173-543.)
    Active substance: FLUCONAZOLE
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    Document reference: 27691
    Study title: FLUCONAZOLE VS. AMPHOTERICIN B: A PROSPECTIVE, RANDOMIZED, MULTICENTER STUDY FOR THERAPY OF FUNGAL INFECTION. (ORIGINATED AT CENTRAL RESEARCH UNDER STUDY NO. 056-173-543.)
    Active substance: FLUCONAZOLE
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    Document reference: 28053
    Study title: FLUCONAZOLE VS. AMPHOTERICIN B: A PROSPECTIVE, RANDOMIZED, STUDY FOR PROPHYLAXIS OF FUNGAL INFECTION IN PATIENTS WITH LEUKEMIA (ORIGINATED AT CENTRAL RESEARCH, GROTON UNDER STUDY NO.056-169
    Active substance: FLUCONAZOLE
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    Document reference: 27687
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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