Streptococcus AgalactiaeDEPIST2PNCT05005169
CCA of SGB PCR Versus SGB Culture at 35-38 SA in the Optimization of Intrapartum Antibiotic Prophylaxis
A study testing SGB PCR and SGB culture in people with Streptococcus Agalactiae, run by Nantes University Hospital at 11 sites in France.
Trial summary
Early-onset neonatal infection (EONI), occur within 7 days of birth. They are most often due to Streptococcus B (GBS) and are associated with heavy and costly morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Streptococcus Agalactiae
- What is being tested?
- SGB PCR and SGB culture
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,321 participants
- Where
- 11 sitesFrance
- Study dates
- 2 Nov 2021to 24 May 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to the delivery room from 35SA upwards
- Planned vaginal delivery
- Patients who agreed to participate in the study and gave oral consent
- Patient affiliated to a social security system
Who cannot join
- Complete dilatation (imminent delivery)
- Scheduled caesarean
- Term < 35 SA
- Death in utero
- Medical termination of pregnancy
- Does not speak French
- Opposition to participating in the study
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Gillard
Angers, 49933
Sentilhes
Bordeaux, 33000
Houllier
Le Kremlin-Bicêtre, 94275
Roumieu
Lyon, 69002
Morel
Nancy, 54000
Multon
Nantes, Saint Herblain, 44819
Kayem
Paris, 75012
Anselem
Paris, 75014
Schmitz
Paris, 75019
Lassel
Rennes, 35203
Lecointre
Strasbourg, 67098
About this study
Official title: Cost-consequence Analysis of Intrapartum Streptococcal B Detection by PCR Versus Antenatal Culture at 35-38 SA in the Optimization of Intrapartum Antibiotic Prophylaxis
Early-onset neonatal infection (EONI), occur within 7 days of birth. They are most often due to Streptococcus B (GBS) and are associated with heavy and costly morbidity and mortality. The strategy combining antenatal detection (PV9) of GBS colonization and intrapartum antibiotic therapy has led to a spectacular decrease in the number of GBS EONI's that have become rare (0.3/1000 births). Current detection is based on the culture of a vaginal swab taken between 35 and 38 SA. Because the positive predictive value of PV9 compared to a culture on the day of delivery is 60%, two problems persist: i) 20% of women and newborns are sometimes unnecessarily exposed to antibiotics with known short-term and long-term harmful effects; ii) more than half of newborns developing EONI are born to mothers with negative PV9. There is a risk of not treating intrapartum colonization when PV9 is negative, and overtreating an uncolonized PV9-positive woman at the time of delivery. These inappropriate antibiotic therapies generate additional maternal-fetal care, examinations, treatments and hospitalizations with significant costs.
Today, a feasible, rapid, sensitive (90-95%) and specific (95-98%) PCR test (Xpert GBS, CEPHEID) can be used to detect women colonized with GBS at the beginning of labor. A recent study (submitted for publication) including 782 women with risk factors for infection (intrapartum fever or prolonged rupture of membranes) who were subjected to PV9 and intrapartum PCR (IP PCR), identified 19% potential reclassification of GBS status, with a potential saving of 6% intrapartum antibiotic.
Read more
We postulate that the replacement of PV9 by the generalized use of GBS intrapartum detection would optimize the indications for intrapartum antiobiotherapy, avoiding (i) unnecessary and deleterious care consumption in the absence of intrapartum GBS colonization, and (ii) avoidable EONIs occurring in the absence of intrapartum antiobiotherapy when GBS colonization has not been diagnosed.
We propose to conduct a cost-consequence study because the criteria for clinically relevant judgments do not allow for cost-effectiveness or cost-utility analysis. Indeed, the intrapartum PCR strategy has consequences for both mother and child and these consequences cannot be aggregated.
Thus, cost-consequence analysis based on criteria validated by clinicians and the literature seemed to us to be the most pragmatic approach and the most likely to help public decision making.
The objective of this work is therefore to carry out a cost-consequence analysis comparing the intrapartum antibiotic prophylaxis strategy based on intrapartum GBS colonization screening by PCR, with the current strategy based on antenatal screening by culture between 35 and 38 SA.
Read the detailed description
- Inclusion visit : The patient is included in the "GBS culture" group or in the "GBS PCR" group determined by the randomization of the hospital in which she gives birth.
A sample to perform the GBS PCR will be taken or not depending on the strategy in place in the center at the time of inclusion. The patient's management will be adapted according to the test result. The administration of intrapartum antibiotic therapy will be decided by the clinician in charge of the patient based on the result of antenatal GBS screening (PCR or culture) and taking into account the risk factors for EONI. In the GBS PCR group, the clinician will not have access to the result of the antenatal detection, even if the result is forgotten or technically impossible.
- M1 follow-up visit (+/-5 days) by phone The study coordinator will follow up the patient by phone.
The data collected are as below:
- Neonatal infection occurring within the first 6 days of life (this diagnosis requires hospital treatment by intravenous route, and will be verified on the hospitalization report),
- Endometritis in the first month after birth,
- Maternal and/or newborn antibiotic therapy (which one? how long? in which indication?)
- Hospitalization of the mother and/or newborn (which hospital, which department, how long? for what reason).
- Hospitalization report.
- Conditions
- Streptococcus Agalactiae
- Being tested
- SGB PCR, SGB culture
- Keywords
- Health economics, streptococcus B, screening, PCR
- Medical subject headings
- Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGB PCRDiagnostic test
Also called Test Xpert® SGB and GeneXpert® Systems / GeneXpert® IV System (GX-4) - CEPHEID
This is a multi-center, randomized cluster and crossover study, and is open-label. The cluster is defined by the hospital center. Each center will therefore experiment with both strategies and the hospital centers will be randomized according to two arms:
- Arm n°1 : 1st period with "SGB culture" strategy and 2nd period with "SGB PCR" strategy.
- Arm n°2 : 1st period with "SGB PCR" Strategy and 2nd period with "SGB culture" Strategy Each inclusion period will last 6 weeks, with a 1-month wash-in period before each of the two inclusion periods of the study (training of the teams in intrapartum PCR detection). A wash-out period is not necessary in this study because the PCR machine will be removed from the centers when switching to the GBS culture strategy.
During these two periods, all patients meeting the inclusion and non-inclusion criteria will be included in the study after presentation of the study and oral consent.
SGB cultureDiagnostic test
This is a multi-center, randomized cluster and crossover study, and is open-label. The cluster is defined by the hospital center. Each center will therefore experiment with both strategies and the hospital centers will be randomized according to two arms:
- Arm n°1 : 1st period with "SGB culture" strategy and 2nd period with "SGB PCR" strategy.
- Arm n°2 : 1st period with "SGB PCR" Strategy and 2nd period with "SGB culture" Strategy Each inclusion period will last 6 weeks, with a 1-month wash-in period before each of the two inclusion periods of the study (training of the teams in intrapartum PCR detection). A wash-out period is not necessary in this study because the PCR machine will be removed from the centers when switching to the GBS culture strategy.
During these two periods, all patients meeting the inclusion and non-inclusion criteria will be included in the study after presentation of the study and oral consent.
| Study group | Role | What they receive |
|---|---|---|
| intrapartum streptococcal B detection by PCR | Experimental | The automatons will be installed by the laboratory in the delivery rooms and used delocalized by the obstetrical teams. Verification and validation of results will be ensured by the microbiology laboratory team, according to the recommendations and procedures already in use for off-site biology. Receives: Diagnostic Test: SGB PCR |
| intrapartum streptococcal B detection by "SGB culture" strategy | Active comparator | Not described Receives: Diagnostic Test: SGB culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of total cost of antenatal culture versus intrapartum PCR screening strategy
Cost-consequence analysis:
- Comparison of the total cost (collective perspective) of the screening strategy (expressed in euros) by antenatal culture versus intrapartum PCR from PV to 30 days postpartum.
Measured: Day 30
Secondary outcomes (6)
Neonatal morbidity-mortality criterion for NPI composite combining over the first 6 days of life
Neonatal morby-mortality criterion: composite criteria (expressed in %)
Measured: Day 6
Criteria for maternal-fetal exposure to antibiotics
Criteria for materno-foetal exposure to ATB (expressed in %)
Measured: Day 30
Maternal morbidity and mortality criteria at 30 days after delivery
- Maternal mortality
Measured: Day 30
Proportion of appropriate intrapartum TBAs in the CRP arm compared to what would have been indicated using current recommendations
Intrapartum antibiotic therapy will be considered appropriate if i) PCR+ at time of delivery with intrapartum TBA ii) indeterminate PCRwith 2 risk factors for infection with intrapartum TBA, iii) PCR negative without intrapartum TBA iv) PCR negative or indeterminate with 0 or 1 risk factor for infection without intrapartum TBA. The comparison will focus on the proportion of TBAs administered in the "SGB culture" arm, which will be the state of practice and the reference in this pragmatic study.
Measured: Day 0
Feasibility criteria for the intrapartum GBS PCR screening strategy
- Feasibility of off-site PCR in the birth room: % of PCRs performed for the entire eligible population
- Proportion of complete TBA ≥ 4h before delivery
- Frequency of PCR "errors" or "invalids
Measured: Day 0
Net financial benefit (cost difference, annually and over 5 years) between different scenarios of dissemination of the strategy considered as efficient (Budget impact analysis; calculation on Excel)
Budget impact analysis allowing to evaluate the net financial benefit of the diffusion of the intrapartum antibiotic prophylaxis strategy based on the screening of GBS colonization in intrapartum by PCR, by comparing scenarios with different rates of development of this strategy, from the National Health Insurance perspective, annually and globally over a 5-year period. This analysis is performed in an Excel sheet, with the following parameters: mean cost of care for this strategy, initial market share of this strategy, expected speed of evolution of its market share compared to other existing strategies.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start2 Nov 2021
- Primary completion8 Jun 2022
- Study completion24 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Streptococcus AgalactiaeStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 3,321 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins
- Responsible party
- Sponsor
- Investigators
- Christèle Gras-Le Guen, Pr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005169
- Sponsor's protocol ID
- RC20_0069
- Acronym
- DEPIST2P
- Status last verified
- Feb 2024
- First submitted
- 20 May 2021
- Last updated
- 23 Feb 2024
- 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 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-consequence Analysis of Intrapartum Streptococcal B Detection by PCR Versus Antenatal Culture at 35-38 SA in the Optimization of Intrapartum Antibiotic Prophylaxis
- ClinicalTrials.gov ID
- NCT05005169
- Acronym / sponsor ID
- DEPIST2P / RC20_0069
- Conditions
- Streptococcus Agalactiae
- Keywords
- Health economics, streptococcus B, screening, PCR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,321 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 8 Jun 2022 (actual)
- Study completion
- 24 May 2023 (actual)
- First posted
- 13 Aug 2021 (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.
Early-onset neonatal infection (EONI), occur within 7 days of birth. They are most often due to Streptococcus B (GBS) and are associated with heavy and costly morbidity and mortality. The strategy combining antenatal detection (PV9) of GBS colonization and intrapartum antibiotic therapy has led to a spectacular decrease in the number of GBS EONI's that have become rare (0.3/1000 births). Current detection is based on the culture of a vaginal swab taken between 35 and 38 SA. Because the positive predictive value of PV9 compared to a culture on the day of delivery is 60%, two problems persist: i) 20% of women and newborns are sometimes unnecessarily exposed to antibiotics with known short-term and long-term harmful effects; ii) more than half of newborns developing EONI are born to mothers with negative PV9. There is a risk of not treating intrapartum colonization when PV9 is negative, and overtreating an uncolonized PV9-positive woman at the time of delivery. These inappropriate antibiotic therapies generate additional maternal-fetal care, examinations, treatments and hospitalizations with significant costs.
Today, a feasible, rapid, sensitive (90-95%) and specific (95-98%) PCR test (Xpert GBS, CEPHEID) can be used to detect women colonized with GBS at the beginning of labor. A recent study (submitted for publication) including 782 women with risk factors for infection (intrapartum fever or prolonged rupture of membranes) who were subjected to PV9 and intrapartum PCR (IP PCR), identified 19% potential reclassification of GBS status, with a potential saving of 6% intrapartum antibiotic.
We postulate that the replacement of PV9 by the generalized use of GBS intrapartum detection would optimize the indications for intrapartum antiobiotherapy, avoiding (i) unnecessary and deleterious care consumption in the absence of intrapartum GBS colonization, and (ii) avoidable EONIs occurring in the absence of intrapartum antiobiotherapy when GBS colonization has not been diagnosed.
We propose to conduct a cost-consequence study because the criteria for clinically relevant judgments do not allow for cost-effectiveness or cost-utility analysis. Indeed, the intrapartum PCR strategy has consequences for both mother and child and these consequences cannot be aggregated.
Thus, cost-consequence analysis based on criteria validated by clinicians and the literature seemed to us to be the most pragmatic approach and the most likely to help public decision making.
The objective of this work is therefore to carry out a cost-consequence analysis comparing the intrapartum antibiotic prophylaxis strategy based on intrapartum GBS colonization screening by PCR, with the current strategy based on antenatal screening by culture between 35 and 38 SA.
Detailed description
- Inclusion visit : The patient is included in the "GBS culture" group or in the "GBS PCR" group determined by the randomization of the hospital in which she gives birth.
A sample to perform the GBS PCR will be taken or not depending on the strategy in place in the center at the time of inclusion. The patient's management will be adapted according to the test result. The administration of intrapartum antibiotic therapy will be decided by the clinician in charge of the patient based on the result of antenatal GBS screening (PCR or culture) and taking into account the risk factors for EONI. In the GBS PCR group, the clinician will not have access to the result of the antenatal detection, even if the result is forgotten or technically impossible.
- M1 follow-up visit (+/-5 days) by phone The study coordinator will follow up the patient by phone.
The data collected are as below:
- Neonatal infection occurring within the first 6 days of life (this diagnosis requires hospital treatment by intravenous route, and will be verified on the hospitalization report),
- Endometritis in the first month after birth,
- Maternal and/or newborn antibiotic therapy (which one? how long? in which indication?)
- Hospitalization of the mother and/or newborn (which hospital, which department, how long? for what reason).
- Hospitalization report.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intrapartum streptococcal B detection by PCR | Experimental | Diagnostic Test: SGB PCRThe automatons will be installed by the laboratory in the delivery rooms and used delocalized by the obstetrical teams. Verification and validation of results will be ensured by the microbiology laboratory team, according to the recommendations and procedures already in use for off-site biology. |
| intrapartum streptococcal B detection by "SGB culture" strategy | Active comparator | Diagnostic Test: SGB culture |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients admitted to the delivery room from 35SA upwards
- Planned vaginal delivery
- Patients who agreed to participate in the study and gave oral consent
- Patient affiliated to a social security system
Key exclusion criteria (7 listed)
- Complete dilatation (imminent delivery)
- Scheduled caesarean
- Term < 35 SA
- Death in utero
- Medical termination of pregnancy
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 |
|---|---|---|
| SGB PCRAlso: Test Xpert® SGB and GeneXpert® Systems / GeneXpert® IV System (GX-4) - CEPHEIDThis is a multi-center, randomized cluster and crossover study, and is open-label. The cluster is defined by the hospital center. Each center will therefore experiment with both strategies and the hospital centers will be randomized according to two arms: * Arm n°1 : 1st period with "SGB culture" strategy and 2nd period with "SGB PCR" strategy. * Arm n°2 : 1st period with "SGB PCR" Strategy and 2nd period with "SGB culture" Strategy Each inclusion period will last 6 weeks, with a 1-month wash-in period before each of the two inclusion periods of the study (training of the teams in intrapartum PCR detection). A wash-out period is not necessary in this study because the PCR machine will be removed from the centers when switching to the GBS culture strategy. During these two periods, all patients meeting the inclusion and non-inclusion criteria will be included in the study after presentation of the study and oral consent. | Diagnostic test | intrapartum streptococcal B detection by PCR |
| SGB cultureThis is a multi-center, randomized cluster and crossover study, and is open-label. The cluster is defined by the hospital center. Each center will therefore experiment with both strategies and the hospital centers will be randomized according to two arms: * Arm n°1 : 1st period with "SGB culture" strategy and 2nd period with "SGB PCR" strategy. * Arm n°2 : 1st period with "SGB PCR" Strategy and 2nd period with "SGB culture" Strategy Each inclusion period will last 6 weeks, with a 1-month wash-in period before each of the two inclusion periods of the study (training of the teams in intrapartum PCR detection). A wash-out period is not necessary in this study because the PCR machine will be removed from the centers when switching to the GBS culture strategy. During these two periods, all patients meeting the inclusion and non-inclusion criteria will be included in the study after presentation of the study and oral consent. | Diagnostic test | intrapartum streptococcal B detection by "SGB culture" strategy |
Primary outcome
Comparison of total cost of antenatal culture versus intrapartum PCR screening strategy
Time frame: Day 30
Cost-consequence analysis: - Comparison of the total cost (collective perspective) of the screening strategy (expressed in euros) by antenatal culture versus intrapartum PCR from PV to 30 days postpartum.
6 secondary outcomes
Neonatal morbidity-mortality criterion for NPI composite combining over the first 6 days of life
Time frame: Day 6
Criteria for maternal-fetal exposure to antibiotics
Time frame: Day 30
Maternal morbidity and mortality criteria at 30 days after delivery
Time frame: Day 30
Proportion of appropriate intrapartum TBAs in the CRP arm compared to what would have been indicated using current recommendations
Time frame: Day 0
Feasibility criteria for the intrapartum GBS PCR screening strategy
Time frame: Day 0
Net financial benefit (cost difference, annually and over 5 years) between different scenarios of dissemination of the strategy considered as efficient (Budget impact analysis; calculation on Excel)
Time frame: 5 years
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 23 Feb 2024.
- 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. This study is not recruiting at the moment.
Christèle Gras-Le Guen, Pr principal investigator
Nantes University Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SGB PCR and SGB culture in people with Streptococcus Agalactiae, run by Nantes University Hospital at 11 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 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 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
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?
Comparison of total cost of antenatal culture versus intrapartum PCR screening strategy (time frame: Day 30). 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 23 Feb 2024.