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Study to Compare the Efficacy and Safety of Micafungin Versus Conventional Amphotericin B for the Treatment of Neonatal Candidiasis (MAGIC-2)

This study has been terminated.
(It was decided to discontinue the study due to insufficient recruitment.)
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
ClinicalTrials.gov Identifier:
NCT00815516
First received: December 27, 2008
Last updated: October 12, 2015
Last verified: October 2015
Results First Received: August 14, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Candidiasis
Interventions: Drug: micafungin
Drug: amphotericin B deoxycholate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Infants greater than 48 hours of life through day of life (DOL) 120 with a diagnosis of invasive candidiasis were eligible for this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In total, 31 infants were screened and 30 were randomized in a 2:1 ratio to receive micafungin or amphotericin B deoxycholate. Randomization was stratified by estimated gestational age (< 27 weeks, ≥ 27 weeks) and by region (North America/Europe, Latin America / Mexico, other region).

Reporting Groups
  Description
Micafungin Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
Amphotericin B Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.

Participant Flow:   Overall Study
    Micafungin     Amphotericin B  
STARTED     20     10  
COMPLETED     16     9  
NOT COMPLETED     4     1  
Death                 3                 1  
Physician Decision                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Micafungin Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
Amphotericin B Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
Total Total of all reporting groups

Baseline Measures
    Micafungin     Amphotericin B     Total  
Number of Participants  
[units: participants]
  20     10     30  
Age  
[units: days]
Mean (Standard Deviation)
  30.2  (27.99)     16.9  (5.13)     25.7  (23.70)  
Age, Customized  
[units: participants]
     
≤ 4 weeks     15     10     25  
> 4 weeks to 4 months     5     0     5  
Gender  
[units: participants]
     
Female     12     4     16  
Male     8     6     14  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     3     3     6  
Not Hispanic or Latino     4     3     7  
Unknown or Not Reported     13     4     17  
Race/Ethnicity, Customized  
[units: participants]
     
White     18     9     27  
Black or African American     0     1     1  
Asian     1     0     1  
Other     1     0     1  
Gestational Age  
[units: participants]
     
< 27 Weeks     3     2     5  
≥ 27 Weeks     17     8     25  
Region of Enrollment  
[units: participants]
     
North America /Europe     15     9     24  
Latin America /Mexico     4     1     5  
Other     1     0     1  
Birth Weight  
[units: grams]
Mean (Standard Deviation)
  1807.3  (879.03)     2171.4  (1008.79)     1928.6  (923.34)  
Fungal Infection Type [1]
[units: participants]
     
Candidemia     12     7     19  
Invasive Candidiasis     8     2     10  
Missing     0     1     1  
Presence of End-Organ Dissemination (EOD) [2]
[units: participants]
     
Yes     7     3     10  
Missing     13     7     20  
[1] Candidemia: diagnosed if Candida isolated from blood only; Invasive candidiasis: diagnosed if Candida isolated from blood in addition to other body fluids such as cerebrospinal fluid (CSF), peritoneal fluid, or urine.
[2] End-organ dissemination was assessed using echocardiogram, abdominal ultrasound, including evaluation of the liver, spleen, and kidneys, head ultrasound, computed tomography (CT) or magnetic resonance imaging (MRI), and retinal exam (if clinically feasible). End-organ dissemination was assessed by the data review panel (DRP). Missing for the DRP assessment means that no evidence for EOD was documented.



  Outcome Measures
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1.  Primary:   Fungal-free Survival   [ Time Frame: One week after the last dose of study drug (maximum of 49 days) ]

2.  Secondary:   Time to Mycological Clearance of Invasive Candidiasis   [ Time Frame: From first dose up to 30 days after the last dose of study drug (maximum of 72 days) ]

3.  Secondary:   Fungal-free Survival at End of Study Drug Therapy in Infants With End-organ Dissemination   [ Time Frame: The end of study drug therapy; maximum of 42 days ]

4.  Secondary:   Fungal-free Survival One Week After Last Dose of Study Drug in Infants With End-organ Dissemination   [ Time Frame: One week after the last dose of study drug (maximum of 49 days) ]

5.  Secondary:   Percentage of Participants With Emergent Fungal Infections   [ Time Frame: Up to 30 days after the last dose of study drug (maximum of 72 days) ]

6.  Secondary:   Percentage of Participants With Recurrent Fungal Infections   [ Time Frame: Up to 30 days after the last dose of study drug (maximum of 72 days) ]

7.  Secondary:   Time to Positive Clinical Response   [ Time Frame: From first dose up to 30 days after the last dose of study drug (maximum of 72 days) ]

8.  Secondary:   Clinical Response at the End of Study Drug Therapy   [ Time Frame: Baseline and end of study drug therapy; maximum of 42 days ]

9.  Secondary:   Clinical Response One Week After Last Dose of Study Drug   [ Time Frame: Baseline and one week after the last dose of study drug (maximum of 49 days) ]

10.  Secondary:   Mycological Response at End of Study Drug Therapy   [ Time Frame: End of study drug therapy; maximum of 42 days ]

11.  Secondary:   Mycological Response One Week After Last Dose of Study Drug   [ Time Frame: One week after the last dose of study drug (maximum of 49 days) ]

12.  Secondary:   Follow-up Status for Infants With End-organ Assessments   [ Time Frame: Baseline and 30 days after the last dose of study drug (maximum of 72 days) ]

13.  Secondary:   Plasma Micafungin Concentration   [ Time Frame: 15 minutes post intravenous infusion (IV), 4-8 hours post IV and 15-24 hours post IV ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Medical Director, Global Medical Science
Organization: Astellas Pharma Global Development, Inc. (APGD)
e-mail: Astellas.resultsdisclosure@astellas.com



Responsible Party: Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
ClinicalTrials.gov Identifier: NCT00815516     History of Changes
Other Study ID Numbers: 9463-CL-2303
2012-000780-24 ( EudraCT Number )
Study First Received: December 27, 2008
Results First Received: August 14, 2015
Last Updated: October 12, 2015
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency
Chile: Instituto de Salud Pública de Chile
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: Ministry of Health
Peru: Ministry of Health
Mexico: Ministry of Health
Canada: Health Canada
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Israel: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health
Bulgaria: Bulgarian Drug Agency
Croatia: Ministry of Health and Social Care
Ecuador: Public Health Ministry
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Korea: Food and Drug Administration
Philippines: Bureau of Food and Drugs
Romania: National Medicines Agency
South Africa: Medicines Control Council
Taiwan : Food and Drug Administration
Thailand: Food and Drug Administration