Back to resultsProcalcitonin and Duration of AntiBiotherapy In Late Onset Sepsis of Neonate (PROABIS)
Primary Purpose
Sepsis
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PCT dosage
Sponsored by
About this trial
This is an interventional treatment trial for Sepsis focused on measuring Late Onset Sepsis (LOS), antibiotic therapy duration, procalcitonin (PCTR)
Eligibility Criteria
Inclusion Criteria:
- Neonates born after 24 weeks of gestation,
- Aged over 96 hours of life, i.e. from the 5th day of life and less than 45 gestational weeks at diagnosis of assumed or proven LOS,
- Weight at the inclusion ≥ 700 g,
- Treated by ATB therapy for less than 48 hours,
- When the physician decides to continue de empiric ATB treatment beyond the initial 48-h period,
- Written informed consent signed by both parents (in the absence of one of the two parents the day of inclusion, the new born can be included with the signature of only one parent.The second parent must give oral consent and sign the consent form as soon as possible "before day 28"),
- Affiliation to a social security system (recipient or assign).
Exclusion Criteria:
- Neonates with non-indication of ATB treatment following the 48h-initial empiric period.
- ATB treatment within the 48h before the current episode of infection; except for taking antibiotics for prophylactic purposes (ex: digestive decontamination), pulmonary-targeted treatments for atypical germs and antibiotics by local means (ex.: eye drops).
- Patients diagnosed with severe infections (meningitis and/or septic shock) or needing prolonged therapy (ex: endocarditis, bone infection, deep seated infection, abscesses). Septic shock is defined by fluid resistant hypotension requiring vasopressor therapy.
- Infections not contracted during the hospitalization in the neonatal period or revealed more than 48 hours after hospital discharge.
- Neonates during treatment by extracorporeal membrane oxygenation or extra-corporeal circulation, and within the 72h after the end of the treatment.
- Neonates previously included in the Proabis study.
- Participation with another interventional study involving human subjects or being in the exclusion period at the end of a previous study involving human subjects.
Sites / Locations
- Pôle de périnatalité Service de néonatologieRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
PCT-guided strategy
Usual practice (control group)
Arm Description
Measurement of PCT concentration will be performed every two days and the ATB therapy will be stopped when PCT level reaches a value equal or below 0.5ng/mL.
Management of LOS and treatment is based on the attending clinician's practice and according to the usual practice.
Outcomes
Primary Outcome Measures
Efficacy of the PCT guided ATB strategy on the duration of ATB treatment compared to usual ATB strategy
Number of days between start and end of treatment, including treatment of the recurrence, if any
Secondary Outcome Measures
Non-inferiority of the PCT-guided ATB strategy to usual strategy on mortality at 28 days following randomization
Mortality rate at 28 days following randomization
Non-inferiority of the PCT-guided ATB strategy to usual strategy on recurrence of infection within 72 hours after ending ATB therapy.
Proportion of infants with a treatment failure and recurrence of infection within 72h after ending ATB treatment and requiring additional course of ATBs.
Description on the total number of assumed or proven bacterial infections within the 28 days following randomization.
Total number of assumed or proven bacterial infections within the 28 days following randomization, excluding the primary infection and its recurrence
To compare the cumulative dose of received ATB treatment (mg/kg).
Cumulative dose of ATB treatment (mg/kg), defined as the total dose (in mg/kg) between start and end of treatment, including treatment of the recurrence, if any
To describe the bacteriological epidemiology of LOS
Recording of all the bacteriological species identified in blood or other samples during the LOS
Proportion of patients with bronchopulmonary dysplasia
Proportion of patients with bronchopulmonary dysplasia in order to assess the proportion of patients with bronchopulmonary dysplasia at 28 days
Proportion of patients with at least one event between randomization and day 28 among death, recurrence of infection and bronchopulmonary dysplasia.
Proportion of patients with at least one event between randomization and day 28 among death, recurrence of infection and bronchopulmonary dysplasia in order to evaluate the endpoint combining death or recurrence of infection or bronchopulmonary dysplasia
Antibiotics free days at D28
Antibiotics free days at D28is defined as the number of days alive without any antibiotics at day 28.
Full Information
NCT ID
NCT03730636
First Posted
November 2, 2018
Last Updated
October 15, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT03730636
Brief Title
Procalcitonin and Duration of AntiBiotherapy In Late Onset Sepsis of Neonate
Acronym
PROABIS
Official Title
Procalcitonin and Duration of AntiBiotherapy In Late Onset Sepsis of Neonate
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 15, 2019 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The duration of antibiotic (ATB) therapy in late onset sepsis (LOS) of the neonate is currently not based on scientific data. The current PROABIS trial will study the use of a biological marker, procalcitonin (PCT), to guide ATB therapy duration in neonates with LOS.
Our hypothesis is that the use of procalcitonin guidance can reduce of 30% the duration of ATB treatment without increasing recurrence of infection and mortality.
Detailed Description
Randomized controlled multicenter open trial comparing the efficacy of PCT guided strategy (superiority aspect) and safety (non-inferiority aspect) versus usual strategy in LOS of the neonate.
After inclusion, patients are randomly assigned (in a 1:1 ratio) to duration of ATB therapy according to PCT guidance (experimental group) or to standard of care (control group).
Experimental group:
For patients randomly assigned in the PCT-guided group, a PCT concentration is measured at D0 (randomisation), at D2 and then, every two days until PCT value is equal or below 0.5 ng/mL.
The physician in charge of the neonate will be strongly encouraged to stop ATB treatment as soon as the PCT value is equal or below 0.5 ng/mL.
Control group:
In the control group, management of LOS and treatment are based on the attending clinician's practice and according to the usual practice (No PCT dosage).
In both groups data will be collected at the follow-up visit (day 14±2 after randomization) or the day of discharge from the hospital (if before 14±2 days) and at the end of the study visit (day 28± 2 after randomization) In case of transfer to another service or hospital or known re hospitalization before day28, outcomes will be collected from the service receiving the patient.
A phone call will be made to the parents, only in case of discharge before 28 days. following randomization. This phone call will be made 28± 2 days after randomization to identify adverse outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
Keywords
Late Onset Sepsis (LOS), antibiotic therapy duration, procalcitonin (PCTR)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2162 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PCT-guided strategy
Arm Type
Experimental
Arm Description
Measurement of PCT concentration will be performed every two days and the ATB therapy will be stopped when PCT level reaches a value equal or below 0.5ng/mL.
Arm Title
Usual practice (control group)
Arm Type
No Intervention
Arm Description
Management of LOS and treatment is based on the attending clinician's practice and according to the usual practice.
Intervention Type
Procedure
Intervention Name(s)
PCT dosage
Intervention Description
Measurement of PCT concentration will be performed every two days and the ATB therapy will be stopped when PCT level reaches a value equal or below 0.5ng/mL.
Primary Outcome Measure Information:
Title
Efficacy of the PCT guided ATB strategy on the duration of ATB treatment compared to usual ATB strategy
Description
Number of days between start and end of treatment, including treatment of the recurrence, if any
Time Frame
up to 28 days
Secondary Outcome Measure Information:
Title
Non-inferiority of the PCT-guided ATB strategy to usual strategy on mortality at 28 days following randomization
Description
Mortality rate at 28 days following randomization
Time Frame
28 days
Title
Non-inferiority of the PCT-guided ATB strategy to usual strategy on recurrence of infection within 72 hours after ending ATB therapy.
Description
Proportion of infants with a treatment failure and recurrence of infection within 72h after ending ATB treatment and requiring additional course of ATBs.
Time Frame
28 days
Title
Description on the total number of assumed or proven bacterial infections within the 28 days following randomization.
Description
Total number of assumed or proven bacterial infections within the 28 days following randomization, excluding the primary infection and its recurrence
Time Frame
28 days
Title
To compare the cumulative dose of received ATB treatment (mg/kg).
Description
Cumulative dose of ATB treatment (mg/kg), defined as the total dose (in mg/kg) between start and end of treatment, including treatment of the recurrence, if any
Time Frame
Day 28
Title
To describe the bacteriological epidemiology of LOS
Description
Recording of all the bacteriological species identified in blood or other samples during the LOS
Time Frame
28 days
Title
Proportion of patients with bronchopulmonary dysplasia
Description
Proportion of patients with bronchopulmonary dysplasia in order to assess the proportion of patients with bronchopulmonary dysplasia at 28 days
Time Frame
28 days
Title
Proportion of patients with at least one event between randomization and day 28 among death, recurrence of infection and bronchopulmonary dysplasia.
Description
Proportion of patients with at least one event between randomization and day 28 among death, recurrence of infection and bronchopulmonary dysplasia in order to evaluate the endpoint combining death or recurrence of infection or bronchopulmonary dysplasia
Time Frame
28 days
Title
Antibiotics free days at D28
Description
Antibiotics free days at D28is defined as the number of days alive without any antibiotics at day 28.
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
96 Hours
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Neonates born after 24 weeks of gestation,
Aged over 96 hours of life, i.e. from the 5th day of life and less than 45 gestational weeks at diagnosis of assumed or proven LOS,
Weight at the inclusion ≥ 700 g,
Treated by ATB therapy for less than 48 hours,
When the physician decides to continue de empiric ATB treatment beyond the initial 48-h period,
Written informed consent signed by both parents (in the absence of one of the two parents the day of inclusion, the new born can be included with the signature of only one parent.The second parent must give oral consent and sign the consent form as soon as possible "before day 28"),
Affiliation to a social security system (recipient or assign).
Exclusion Criteria:
Neonates with non-indication of ATB treatment following the 48h-initial empiric period.
ATB treatment within the 48h before the current episode of infection; except for taking antibiotics for prophylactic purposes (ex: digestive decontamination), pulmonary-targeted treatments for atypical germs and antibiotics by local means (ex.: eye drops).
Patients diagnosed with severe infections (meningitis and/or septic shock) or needing prolonged therapy (ex: endocarditis, bone infection, deep seated infection, abscesses). Septic shock is defined by fluid resistant hypotension requiring vasopressor therapy.
Infections not contracted during the hospitalization in the neonatal period or revealed more than 48 hours after hospital discharge.
Neonates during treatment by extracorporeal membrane oxygenation or extra-corporeal circulation, and within the 72h after the end of the treatment.
Neonates previously included in the Proabis study.
Participation with another interventional study involving human subjects or being in the exclusion period at the end of a previous study involving human subjects.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Delphine MITANCHEZ, PU-PH
Phone
00 331 44 73 61 91
Email
delphine.mitanchez@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Delphine MITANCHEZ, PU-PH
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pôle de périnatalité Service de néonatologie
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75012
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Delphine MITANCHEZ, PU-PH
Phone
00 331 44 73 61 91
Email
delphine.mitanchez@aphp.fr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Procalcitonin and Duration of AntiBiotherapy In Late Onset Sepsis of Neonate
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