UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025633 |
|---|---|
| Receipt number | 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 17:31:46 |
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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
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
giovanni.vento@unicatt.it
Sponsor or person
Institute
Institute of Pediatric, Division of Neonatology - Fondazione Policlinico Universitario Agostino Gemelli
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028953
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
