Bacterial InfectionsPRODISCONCT05350813
Impact of Procalcitonin-guided Algorithm on Early Discontinuation of Antibiotic Therapy
A study testing Measurement of the PCT plasma levels and Usual practice based on guidelines in people with Bacterial Infections, run by University Hospital, Toulouse at 8 sites in France.
Trial summary
In this randomized controlled open-label trial, conducted in 7 French Pediatric and Neonatal Intensive Care Units (ICUs), investigator team hypothesize that the use of a procalcitonin (PCT)-guided algorithm to discontinue antibiotic treatment will decrease antibiotic duration in critically ill children treated for a… Read more about this study
- Who is it for?
- Ages 3 days to 17 years
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- Measurement of the PCT plasma levels and Usual practice based on guidelines
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 8 sitesFrance
- Study dates
- 2 May 2023to 2 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 days to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates, infants and children hospitalized in Pediatric and Neonatal ICU and receiving intravenous antibiotics for less than 24 hours for an episode of suspected or proven community-acquired or nosocomial bacterial infection.
- Written informed consent signed by both parents or legal guardians.
- Affiliated to a social security scheme.
- Parents French-speaking.
Who cannot join
- Newborns <72 hours old.
- Neonates <37 weeks postmenstrual age.
- Age ≥18 years.
- Pregnant or breastfeeding women.
- Patients with cystic fibrosis.
- Immunocompromised patients including patients with hereditary immunodeficiency, agranulocytosis (neutrophils count <500/mm3), HIV infection with CD4 count <200/mm3, sickle cell disease, those who have undergone splenectomy, those who have a history of solid organ or hematopoietic stem cell transplant, those with hemopathy or solid organ tumor treated with chemotherapy, and those on immunosuppressive drugs including systemic corticosteroids taken daily for at least 15 days prior to Day 0.
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- Inflammatory situations increasing PCT plasma concentrations in the absence of infection: burns, extracorporeal membrane oxygenation (ECMO), first 48 hours following an open-heart cardiac surgery with cardiopulmonary bypass.
- Infections requiring prolonged antibiotic therapy: infected thrombophlebitis, infective endocarditis, mediastinitis, abscess or empyema (e.g. peritonsillar abscess, retropharyngeal abscess, adenophlegmon, retroauricular abscess, retroorbital abscess, pulmonary abscess, pleural empyema, liver abscess, splenic abscess, brain abscess, subdural empyema, extradural empyema, epidural abscess, intramuscular abscess), necrotizing dermohypodermitis or necrotizing fasciitis, osteomyelitis, osteitis, arthritis, spondylodiscitis, prostatitis, tuberculosis, meningitis except those caused by Haemophilus and Meningococcus, infection on a device excluding intravascular catheter, endotracheal tube, tracheostomy, and urinary catheter.
- Antibiotic for prophylaxis.
- Children previously included in an interventional study in progress.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites, 4 recruiting
- Active, not recruiting
CHU Amiens Picardie
Amiens
- Active, not recruiting
CHU de Bordeaux
Bordeaux
- Recruiting
CHU de Clermont Ferrand
Clermont-Ferrand
Nadia SAVY, MD
Nadia SAVY, MD
- Terminated
University Hospital of Lille
Lille
- Recruiting
CHU de NANTES
Nantes
Brendan TRAVERT, MD
Brendan TRAVERT, MD
- Active, not recruiting
APHP
Paris
- Recruiting
CHU La Réunion
Saint-Denis
Pauline DUPORT, MD
Pauline DUPORT, MD
- Recruiting
University Hospital of Toulouse
Toulouse, 31100
Armelle BRIDIER, MD
Armelle BRIDIER, MD
About this study
Official title: Impact of Procalcitonin-guided Algorithm on Early Discontinuation of Antibiotic Therapy in Pediatric Intensive Care Units : a Multicenter Randomized Controlled Trial
In this randomized controlled open-label trial, conducted in 7 French Pediatric and Neonatal Intensive Care Units (ICUs), investigator team hypothesize that the use of a procalcitonin (PCT)-guided algorithm to discontinue antibiotic treatment will decrease antibiotic duration in critically ill children treated for a suspected or proven bacterial infection. Two hundred and ninety-six eligible patients will be randomly assigned in two groups: either PCT-guided or standard-of-care antibiotic discontinuation, and monitored over 28 days, until the end of their hospitalization, or up to the end of antibiotic treatment for bacterial infection recurrence occurring up to 28 days after the day of randomization.
Read the detailed description
Infections are widespread in Pediatric and Neonatal ICU, and antibiotic treatments widely used. Long courses of antibiotic treatment increase the duration of hospitalization and are associated with changes in the microbiome, emergence of multidrug resistant organisms, and antibiotic-associated adverse events. In Pediatric and Neonatal ICU, PCT has a high negative predictive value to rule out bacterial infection. Thus, in sepsis patients and patients who initially appear to have sepsis but whose final diagnosis of bacterial infection is not retained, the use of a PCT-guided algorithm may be of value to shorten antibiotic duration without increasing infection recurrences. The algorithm has provided strong evidence of efficacy and safety among critically ill adults, excluding immunocompromised patients, patients with cystic fibrosis, and infections requiring prolonged antibiotic therapy. Similar data in critically ill children are lacking. A Spanish team from Sant Joan de Déu published three prospective non-randomized studies in Pediatric ICU (PICU), with encouraging results. Only one American randomized controlled trial (RCT) has been published in PICU with mixed results. One RCT is ongoing in India. Thus, our study will be the first French RCT to study the use of a PCT-guided algorithm to de-escalate antibiotic therapy in PICU, in order to provide evidence of efficacy and safety of such an algorithm in critically ill children with a suspected or proven bacterial infection. In addition, investigator team will also study the economic impact of a PCT-guided algorithm which has never been done before.
In the PCT-guided arm, PCT dosage will be done at Day 0 (day of randomization) and Day 1, and then every 48 hours until cessation of antibiotics in hospital or discharge from hospital if the patient is discharged with an antibiotic treatment. Antibiotic treatment will be stopped according to PCT value and patient clinical evolution. In the control group, antibiotic duration will be determined by usual practices based on guidelines. Inpatient evaluations will be conducted every day so long as patients receives antibiotics in hospital and usual clinical, biological and/or radiological monitoring will be conducted in both groups. To monitor infection recurrence occurring up to 28 days after the day of randomization and antibiotic-related adverse events, an evaluation will be conducted at the end of hospitalization, another at Day 28 (Day 0 = day of randomization), and a last at the end of antibiotic treatment bacterial infection recurrence, if the patient is discharged from hospital on or before Day 28 and is still treated with antibiotics for a bacterial infection recurrence at Day 28, or if the patient is discharged from hospital after Day 28 and is still treated for recurrence on the last day of hospitalization with antibiotics for a bacterial infection recurrence.
- Conditions
- Bacterial Infections
- Being tested
- Measurement of the PCT plasma levels, Usual practice based on guidelines
- Keywords
- procalcitonin, Children, Pediatric Intensive Care Unit, Procalcitonin-guided antibiotic therapy, Algorithm
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of the PCT plasma levelsProcedure or surgery
antibiotic treatment duration will be based on PCT plasma levels
Usual practice based on guidelinesProcedure or surgery
antibiotic therapy duration will be determined by the type of infection, microbiological results and clinical, biological and/or radiological evolution, according to the usual practice based on guidelines.
| Study group | Role | What they receive |
|---|---|---|
| PCT-guided arm | Experimental | Group of patients whose duration of antibiotic therapy will depend on procalcitonin (PCT) plasma levels on days 0 and 1, then on PCT plasma level every 48 hours and on patient clinical evolution evaluated by the fever, the infected organ, and the pSOFA (Pediatric Sequential Organ Failure Assessment) score every day until cessation of antibiotics in hospital or until discharge from hospital if the patient is discharged with an antibiotic treatment. Receives: Procedure: Measurement of the PCT plasma levels |
| standard-of-care arm | Active comparator | A group of patients whose duration of antibiotic therapy will be determined by the type of infection, microbiological findings and clinical, biological and/or radiological course, according to standard practice based on guidelines. Receives: Procedure: Usual practice based on guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total duration of antibiotic therapy (in days) for a suspected or proven bacterial infection, including the first episode and recurrences occurring within 28 days following the day of randomization
Duration of antibiotic therapy (in days) including the length of treatment for recurrences occurring within 28 days following the day of randomization. The duration of antibiotic therapy for the first episode of suspected or proven bacterial infection is the time interval, expressed in days, between the starting time of intravenous antibiotics and the stopping time of the antibiotic therapy (intravenous, intramuscular or oral). The duration of antibiotic therapy for a recurrence of bacterial infection is the time interval, expressed in days, between the starting time of a new antimicrobial therapy (intravenous, intramuscular or oral) covering the initial causative bacteria within 28 days following the day of randomization, and the stopping time of this antibiotic therapy (even if ending after 28 days following the day of randomization).
Measured: month 3 (maximum follow-up period of 3 months)
Secondary outcomes (12)
Total duration of broad-spectrum antibiotic therapy in days) for a suspected or proven bacterial infection, including the first episode and recurrences
Duration of broad-spectrum antibiotic therapy (in days) including the length of treatment for recurrences occurring within 28 days following the day of randomization, and also the length of treatment for recurrences occurring within 28 days following the day of randomization. To identify broad-spectrum antibiotics, we used separately two definitions. Based on the historical definition, broad-spectrum antibiotics were all antibiotics except those with a useful activity against only Gram-positive bacteria (penicillin G, oxacillin, vancomycin, teicoplanin, linezolid, macrolides, clindamycin) and those whose main activity is against Gram-positive bacteria (amoxicillin, 1st generation cephalosporin [cefazolin, cephalexin], 2nd generation cephalosporin [cefuroxime, cefaclor, cefamandole], rifampicin).
Measured: month 3 (maximum follow-up period of 3 months)
Length of Intensive Care Unit stay (in days) from Day 0 (day of randomization)
Length of Intensive Care Unit stay (in days) from Day 0 (day of randomization)
Measured: month 3 (maximum follow-up period of 3 months)
Length of hospital stay from Day 0 (day of randomization)
Length of hospital stay from Day 0 (day of randomization)
Measured: month 3 (maximum follow-up period of 3 months)
Recurrence of bacterial infection within 28 days following the day of randomization
Proportion of children with recurrence of bacterial infection within 28 days following the day of randomization. The recurrence of bacterial infection is defined as the isolation of one or more of the initial causative bacteria from the same or another site at 48 hours or more after cessation of antibiotics, combined with clinical signs or symptoms of infection, or the need to prescribe a new antimicrobial therapy covering this pathogen. All recurrences of bacterial infection occurring up to Day 28, and treated in hospital (same hospital stay as for the first episode, or new hospital stay) or in ambulatory care, will be taken into account.
Measured: day 28
All cause mortality at Day 28 (Day 0 = day of randomization)
All cause mortality rate at Day 28 (Day 0 = day of randomization). All-cause mortality is a measure of all deaths, due to any cause, that occur during a clinical study.
Measured: day 28
All cause mortality at the end of antibiotic treatment for bacterial infection recurrence (if ending after Day 28)
All cause mortality rate at the end of antibiotic treatment for bacterial infection recurrence (if ending after Day 28). All-cause mortality is a measure of all deaths, due to any cause, that occur during a clinical study.
Measured: month 3 (maximum follow-up period of 3 months)
Sepsis-related mortality at Day 28 (Day 0 = day of randomization)
Sepsis-related mortality rate at Day 28 (Day 0 = day of randomization). Sepsis-related mortality is a measure of all deaths related to the first bacterial infection episode or bacterial infection recurrence, that occur during the study.
Measured: day 28
Sepsis-related mortality at the end of antibiotic treatment for bacterial infection recurrence (if ending after Day 28).
Sepsis-related mortality rate at the end of antibiotic treatment for bacterial infection recurrence (if ending after Day 28). Sepsis-related mortality is a measure of all deaths related to the first bacterial infection episode or bacterial infection recurrence, that occur during the study.
Measured: month 3 (maximum follow-up period of 3 months)
Antibiotic-related adverse events
Antibiotic-related adverse events
Measured: month 3 (maximum follow-up period of 3 months)
Adherence to the PCT-guided algorithm
This outcome will be evaluated by a stop of antibiotics within 24 hours after reaching stopping criteria : - Before Day 3: PCT levels at Day 0 and Day 1 less than 0.5 ng/mL.; - Starting Day 3: PCT level less than 0.5 ng/mL or down by ≥80% from the peak value since Day 0 AND favorable patient clinical course (defined by a decrease in pSOFA score compared to maximal value at Day 0 or Day 1, a reduction of fever and an improvement of the infected organ). - Or if the antibiotic duration, as defined by current infectious guidelines, is reached and the patient shows a favorable course, even if PCT is still ≥0.5 ng/mL or >20% of the peak value.
Measured: month 3 (maximum follow-up period of 3 months)
Incremental cost-effectiveness ratios
This outcome will be expressed in terms of hospital costs per number of patients without recurrent bacterial infection at 3 months and hospital costs per number of patients alive at 3 months
Measured: month 3
Costs of antibiotic therapy and PCT testing during each inpatient stay
Costs of antibiotic therapy and PCT testing during each inpatient stay
Measured: month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start2 May 2023
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 296 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Montserrat SIERRA COLOMINA, MD, Principal investigator, University Hospital of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350813
- Sponsor's protocol ID
- RC31/21/0334
- Other IDs
- 2022-A00246-37
- Acronym
- PRODISCO
- Status last verified
- Aug 2026
- First submitted
- 15 Apr 2022
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Procalcitonin-guided Algorithm on Early Discontinuation of Antibiotic Therapy in Pediatric Intensive Care Units : a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05350813
- Acronym / sponsor ID
- PRODISCO / RC31/21/0334
- Conditions
- Bacterial Infections
- Keywords
- procalcitonin, Children, Pediatric Intensive Care Unit, Procalcitonin-guided antibiotic therapy, Algorithm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 296 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 28 Apr 2022 (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.
In this randomized controlled open-label trial, conducted in 7 French Pediatric and Neonatal Intensive Care Units (ICUs), investigator team hypothesize that the use of a procalcitonin (PCT)-guided algorithm to discontinue antibiotic treatment will decrease antibiotic duration in critically ill children treated for a suspected or proven bacterial infection. Two hundred and ninety-six eligible patients will be randomly assigned in two groups: either PCT-guided or standard-of-care antibiotic discontinuation, and monitored over 28 days, until the end of their hospitalization, or up to the end of antibiotic treatment for bacterial infection recurrence occurring up to 28 days after the day of randomization.
Detailed description
Infections are widespread in Pediatric and Neonatal ICU, and antibiotic treatments widely used. Long courses of antibiotic treatment increase the duration of hospitalization and are associated with changes in the microbiome, emergence of multidrug resistant organisms, and antibiotic-associated adverse events. In Pediatric and Neonatal ICU, PCT has a high negative predictive value to rule out bacterial infection. Thus, in sepsis patients and patients who initially appear to have sepsis but whose final diagnosis of bacterial infection is not retained, the use of a PCT-guided algorithm may be of value to shorten antibiotic duration without increasing infection recurrences. The algorithm has provided strong evidence of efficacy and safety among critically ill adults, excluding immunocompromised patients, patients with cystic fibrosis, and infections requiring prolonged antibiotic therapy. Similar data in critically ill children are lacking. A Spanish team from Sant Joan de Déu published three prospective non-randomized studies in Pediatric ICU (PICU), with encouraging results. Only one American randomized controlled trial (RCT) has been published in PICU with mixed results. One RCT is ongoing in India. Thus, our study will be the first French RCT to study the use of a PCT-guided algorithm to de-escalate antibiotic therapy in PICU, in order to provide evidence of efficacy and safety of such an algorithm in critically ill children with a suspected or proven bacterial infection. In addition, investigator team will also study the economic impact of a PCT-guided algorithm which has never been done before.
In the PCT-guided arm, PCT dosage will be done at Day 0 (day of randomization) and Day 1, and then every 48 hours until cessation of antibiotics in hospital or discharge from hospital if the patient is discharged with an antibiotic treatment. Antibiotic treatment will be stopped according to PCT value and patient clinical evolution. In the control group, antibiotic duration will be determined by usual practices based on guidelines. Inpatient evaluations will be conducted every day so long as patients receives antibiotics in hospital and usual clinical, biological and/or radiological monitoring will be conducted in both groups. To monitor infection recurrence occurring up to 28 days after the day of randomization and antibiotic-related adverse events, an evaluation will be conducted at the end of hospitalization, another at Day 28 (Day 0 = day of randomization), and a last at the end of antibiotic treatment bacterial infection recurrence, if the patient is discharged from hospital on or before Day 28 and is still treated with antibiotics for a bacterial infection recurrence at Day 28, or if the patient is discharged from hospital after Day 28 and is still treated for recurrence on the last day of hospitalization with antibiotics for a bacterial infection recurrence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCT-guided arm | Experimental | Procedure: Measurement of the PCT plasma levelsGroup of patients whose duration of antibiotic therapy will depend on procalcitonin (PCT) plasma levels on days 0 and 1, then on PCT plasma level every 48 hours and on patient clinical evolution evaluated by the fever, the infected organ, and the pSOFA (Pediatric Sequential Organ Failure Assessment) score every day until cessation of antibiotics in hospital or until discharge from hospital if the patient is discharged with an antibiotic treatment. |
| standard-of-care arm | Active comparator | Procedure: Usual practice based on guidelinesA group of patients whose duration of antibiotic therapy will be determined by the type of infection, microbiological findings and clinical, biological and/or radiological course, according to standard practice based on guidelines. |
Who may qualify
- Ages
- 3 days to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Neonates, infants and children hospitalized in Pediatric and Neonatal ICU and receiving intravenous antibiotics for less than 24 hours for an episode of suspected or proven community-acquired or nosocomial bacterial infection.
- Written informed consent signed by both parents or legal guardians.
- Affiliated to a social security scheme.
- Parents French-speaking.
Key exclusion criteria (10 listed)
- Newborns <72 hours old.
- Neonates <37 weeks postmenstrual age.
- Age ≥18 years.
- Pregnant or breastfeeding women.
- Patients with cystic fibrosis.
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 |
|---|---|---|
| Measurement of the PCT plasma levelsantibiotic treatment duration will be based on PCT plasma levels | Procedure or surgery | PCT-guided arm |
| Usual practice based on guidelinesantibiotic therapy duration will be determined by the type of infection, microbiological results and clinical, biological and/or radiological evolution, according to the usual practice based on guidelines. | Procedure or surgery | standard-of-care arm |
Primary outcome
Total duration of antibiotic therapy (in days) for a suspected or proven bacterial infection, including the first episode and recurrences occurring within 28 days following the day of randomization
Time frame: month 3 (maximum follow-up period of 3 months)
Duration of antibiotic therapy (in days) including the length of treatment for recurrences occurring within 28 days following the day of randomization. The duration of antibiotic therapy for the first episode of suspected or proven bacterial infection is the time interval, expressed in days, between the starting time of intravenous antibiotics and the stopping time of the antibiotic therapy (intravenous, intramuscular or oral). The duration of antibiotic therapy for a recurrence of bacterial infection is the time interval, expressed in days, between the starting time of a new antimicrobial therapy (intravenous, intramuscular or oral) covering the initial causative bacteria within 28 days following the day of randomization, and the stopping time of this antibiotic therapy (even if ending after 28 days following the day of randomization).
12 secondary outcomes
Total duration of broad-spectrum antibiotic therapy in days) for a suspected or proven bacterial infection, including the first episode and recurrences
Time frame: month 3 (maximum follow-up period of 3 months)
Length of Intensive Care Unit stay (in days) from Day 0 (day of randomization)
Time frame: month 3 (maximum follow-up period of 3 months)
Length of hospital stay from Day 0 (day of randomization)
Time frame: month 3 (maximum follow-up period of 3 months)
Recurrence of bacterial infection within 28 days following the day of randomization
Time frame: day 28
All cause mortality at Day 28 (Day 0 = day of randomization)
Time frame: day 28
All cause mortality at the end of antibiotic treatment for bacterial infection recurrence (if ending after Day 28)
Time frame: month 3 (maximum follow-up period of 3 months)
Sepsis-related mortality at Day 28 (Day 0 = day of randomization)
Time frame: day 28
Sepsis-related mortality at the end of antibiotic treatment for bacterial infection recurrence (if ending after Day 28).
Time frame: month 3 (maximum follow-up period of 3 months)
Antibiotic-related adverse events
Time frame: month 3 (maximum follow-up period of 3 months)
Adherence to the PCT-guided algorithm
Time frame: month 3 (maximum follow-up period of 3 months)
Incremental cost-effectiveness ratios
Time frame: month 3
Costs of antibiotic therapy and PCT testing during each inpatient stay
Time frame: month 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Montserrat SIERRA COLOMINA, MD principal investigator
University Hospital of Toulouse
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement of the PCT plasma levels and Usual practice based on guidelines in people with Bacterial Infections, run by University Hospital, Toulouse at 8 sites 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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Montserrat SIERRA COLOMINA, MD (05 61 74 51 45 ext. +33, sierracolomina.m@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total duration of antibiotic therapy (in days) for a suspected or proven bacterial infection, including the first episode and recurrences occurring within 28 days following the day of randomization (time frame: month 3 (maximum follow-up period of 3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2026.