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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025633
Receipt No. R000028953
Scientific Title Randomized control trial on the efficacy of a preemptive therapy based on positive Mn-antigen detection in BALF in an invasive candidiasis high risk population of preterm infants
Date of disclosure of the study information 2017/01/14
Last modified on 2018/01/13

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Basic information
Public title Randomized control trial on the efficacy of a preemptive therapy based on positive Mn-antigen detection in BALF in an invasive candidiasis high risk population of preterm infants
Acronym Preemptive antimicotic therapy and Mn-antigen detection in preterm neonatal BALF
Scientific Title Randomized control trial on the efficacy of a preemptive therapy based on positive Mn-antigen detection in BALF in an invasive candidiasis high risk population of preterm infants
Scientific Title:Acronym Preemptive antimicotic therapy and Mn-antigen detection in preterm neonatal BALF
Region
Europe

Condition
Condition Invasive candidiasis risk in preterm neonates
Classification by specialty
Infectious disease Pediatrics Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy in reducing pulmonary damage of a preemptive therapy with voriconazole or micafungin compared to only fluconazole prophylaxis, based on positive Mn-antigen detection in BALF of preterm infants.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Day of extubation
Incidence of BPD at 36 weeks of postconceptual age
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administration of Voriconazole iv at the dose of 9 mg/kg twice a day in the first day of treatment, andc then 8 mg/kg
twice a day for others 13 days
Interventions/Control_2 Administration of Micafungin iv at the dose of 10 mg/kg/die in a single dose for 14 days
Interventions/Control_3 Administration of Fluconazole iv at the dose of 3 mg/kg twice a week (on tuesday and
friday) until central venus catheter is needed
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
1 days-old <=
Age-upper limit
7 days-old >
Gender Male and Female
Key inclusion criteria Neonates with gestational age <= 30 weeks and/or birth weight <= 1000 gr, needing mechanical ventilation in the first week of life and receiving fluconazole prophylaxis
Key exclusion criteria Major malformation
Target sample size 114

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Giovanni Vento
Organization Fondazione Policlinico Universitario Agostino Gemelli
Division name Neonatology
Zip code
Address Largo Agostino Gemelli 8, 00168 Rome, Italy
TEL +390630154357
Email giovanni.vento@unicatt.it

Public contact
Name of contact person
1st name
Middle name
Last name Giovanni Vento
Organization Fondazione Policlinico Universitario Agostino Gemelli
Division name Neonatology
Zip code
Address Largo Agostino Gemelli 8, 00168 Rome, Italy
TEL +390630154357
Homepage URL
Email giovanni.vento@unicatt.it

Sponsor
Institute Institute of Pediatric, Division of Neonatology - Fondazione Policlinico Universitario Agostino Gemelli
Institute
Department

Funding Source
Organization Institute of Pediatric, Division of Neonatology - Fondazione Policlinico Universitario Agostino Gemelli
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 14 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2014 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
2017 Year 12 Month 15 Day
Date trial data considered complete
2017 Year 12 Month 20 Day
Date analysis concluded
2018 Year 01 Month 10 Day

Other
Other related information

Management information
Registered date
2017 Year 01 Month 12 Day
Last modified on
2018 Year 01 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028953

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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