SepsisPROABISNCT03730636
Procalcitonin and Duration of AntiBiotherapy In Late Onset Sepsis of Neonate
A study testing PCT dosage in people with Sepsis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 96 hours to 1 month
- Conditions the study is for
- Sepsis
- What is being tested?
- PCT dosage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 511 participants
- Where
- 1 siteFrance
- Study dates
- 15 Feb 2019to 7 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 96 hours to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates born at 24 or more 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Sepsis
- Being tested
- PCT dosage
- Keywords
- Late Onset Sepsis (LOS), antibiotic therapy duration, procalcitonin (PCTR)
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCT dosageProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| PCT-guided strategy | Experimental | 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. Receives: Procedure: PCT dosage |
| Usual practice (control group) | No intervention | Management of LOS and treatment is based on the attending clinician's practice and according to the usual practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 28 days
Secondary outcomes (8)
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
Measured: 28 days
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.
Measured: 28 days
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
Measured: 28 days
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
Measured: Day 28
To describe the bacteriological epidemiology of LOS
Recording of all the bacteriological species identified in blood or other samples during the LOS
Measured: 28 days
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
Measured: 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
Measured: 28 days
Antibiotics free days at D28
Antibiotics free days at D28is defined as the number of days alive without any antibiotics at day 28.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start15 Feb 2019
- Primary completion7 Mar 2023
- Study completion7 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 511 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Delphine MITANCHEZ, PU-PH, Principal investigator, Department of Neonatology Bretonneau Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730636
- Sponsor's protocol ID
- P170928J
- Other IDs
- 2018-AO1396-49
- Acronym
- PROABIS
- Status last verified
- Mar 2024
- First submitted
- 2 Nov 2018
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mitanchez D, Lacoste-Badie R, Flamant C, Beuchee A, Tourneux P, Mokhtari M, Jarreau PH, Tuffet S, Berard L, Rousseau A, Gras-Le Guen C; ProABIS Study Group. Procalcitonin-guided decision and antibiotic treatment duration in late onset sepsis of newborns: multicentre, randomised controlled trial (ProABIS). BMJ Med. 2026 May 17;5(1):e002602. doi: 10.1136/bmjmed-2026-002602. eCollection 2026.
PubMed 42157905
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procalcitonin and Duration of AntiBiotherapy In Late Onset Sepsis of Neonate
- ClinicalTrials.gov ID
- NCT03730636
- Acronym / sponsor ID
- PROABIS / P170928J
- Conditions
- Sepsis
- Keywords
- Late Onset Sepsis (LOS), antibiotic therapy duration, procalcitonin (PCTR)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 511 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 7 Mar 2023 (actual)
- Study completion
- 7 Mar 2023 (actual)
- First posted
- 5 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCT-guided strategy | Experimental | Procedure: PCT dosageMeasurement 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. |
| Usual practice (control group) | No intervention | –Management of LOS and treatment is based on the attending clinician's practice and according to the usual practice. |
Who may qualify
- Ages
- 96 hours to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Neonates born at 24 or more 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,
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCT dosageMeasurement 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. | Procedure or surgery | PCT-guided strategy |
Primary outcome
Efficacy of the PCT guided ATB strategy on the duration of ATB treatment compared to usual ATB strategy
Time frame: up to 28 days
Number of days between start and end of treatment, including treatment of the recurrence, if any
8 secondary outcomes
Non-inferiority of the PCT-guided ATB strategy to usual strategy on mortality at 28 days following randomization
Time frame: 28 days
Non-inferiority of the PCT-guided ATB strategy to usual strategy on recurrence of infection within 72 hours after ending ATB therapy.
Time frame: 28 days
Description on the total number of assumed or proven bacterial infections within the 28 days following randomization.
Time frame: 28 days
To compare the cumulative dose of received ATB treatment (mg/kg).
Time frame: Day 28
To describe the bacteriological epidemiology of LOS
Time frame: 28 days
Proportion of patients with bronchopulmonary dysplasia
Time frame: 28 days
Proportion of patients with at least one event between randomization and day 28 among death, recurrence of infection and bronchopulmonary dysplasia.
Time frame: 28 days
Antibiotics free days at D28
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Derived from this study: PubMed 42157905Mitanchez D, Lacoste-Badie R, Flamant C, Beuchee A, Tourneux P, Mokhtari M, Jarreau PH, Tuffet S, Berard L, Rousseau A, Gras-Le Guen C; ProABIS Study Group. Procalcitonin-guided decision and antibiotic treatment duration in late onset sepsis of newborns: multicentre, randomised controlled trial (ProABIS). BMJ Med. 2026 May 17;5(1):e002602. doi: 10.1136/bmjmed-2026-002602. eCollection 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Delphine MITANCHEZ, PU-PH principal investigator
Department of Neonatology Bretonneau Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCT dosage in people with Sepsis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of the PCT guided ATB strategy on the duration of ATB treatment compared to usual ATB strategy (time frame: up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03730636, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.