Acute Chest SyndromeAntibio_STANCT03919266
Combined Use of a Respiratory Broad Panel Multiplex PCR and Procalcitonin to Reduce Antibiotics Exposure in Hospitalized Sickle-cell Adults With Acute Chest Syndrome.
A study testing Intervention: Combined use of a respiratory broad panel multiplex PCR and procalcitonin in people with Acute Chest Syndrome and Sickle Cell Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Many patients with Sickle Cell Disease (SCD) may develop Acute Chest Syndrome (ACS). ACS is usually caused by a Lower respiratory tract infection (LRTI) which may be caused by either a bacterium or a virus. Antibiotics are usually used for 7 to 10 days with no microbiological workup. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Chest Syndrome, Sickle Cell Disease
- What is being tested?
- Intervention: Combined use of a respiratory broad panel multiplex PCR and procalcitonin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jun 2020to 10 Oct 2022
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Sickle Cell Disease patients with ACS with an antibiotic therapy indication
- Signed and informed consent
- Affiliated with social security
Who cannot join
- Documented extra-pulmonary bacterial infection at the time of inclusion;
- Patients who received antibiotics for more than 24 hours before the diagnosis of ACS (during the primary hospitalization)
- Known severe immunosuppression (AIDS, neutropenia (<1000 PNN), hematology, solid tumor under chemotherapy, transplanted organ); long-term treatment with hydroxy-carbamide is not considered
- Pregnant or lactating women;
- Person deprived of liberty or under legal protection;
- Participation in another interventional study of type Jardé 1
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Use of a Respiratory Broad Panel Multiplex PCR and Procalcitonin to Reduce Antibiotics Exposure in Adult Patients With Sickle-cell Disease Hospitalized for Acute Chest Syndrome. A Bi-centric, Open, Parallel-group, Randomized Controlled Study
Many patients with Sickle Cell Disease (SCD) may develop Acute Chest Syndrome (ACS). ACS is usually caused by a Lower respiratory tract infection (LRTI) which may be caused by either a bacterium or a virus. Antibiotics are usually used for 7 to 10 days with no microbiological workup.
The hypothesis of the study is that the identification of the microorganisms might lead to a reduction of antibiotics exposure and a better care of the patients.
We speculate that an early pathogen-directed strategy (respiratory broad panel multiplex PCR and early antibiotics interruption based on the PCT values decrease) might reduce the antibiotics exposure in SCD patients with ACS who are hospitalized and for whom an antibiotic treatment is indicated, as compared with usual care
Read the detailed description
Acute Chest Syndrome (ACS) is a frequent and severe acute complication of sickle-cell disease. It may affect 10 to 20% of hospitalized patients and is the leading cause of death. The symptoms combine a new pulmonary infiltrate and symptom(s) among fever, cough, dyspnea, expectoration, chest pain and crackles. The pathophysiology of ACS is complex and there are many interlinked aetiologies.
Lower respiratory tract infection (LRTI) is one of the most frequent aetiologies of ACS. Intracellular bacteria (Chlamydia, Mycoplasma), respiratory virus (especially respiratory syncytial virus) and pyogenes (Streptococcus pneumoniae and Staphylococcus aureus) are the most frequently identified microorganisms. Nevertheless, the clinical presentation of ACS is not helpful for the diagnosis of LRTI; the respiratory tract samples are not always collected, either because the patients do not expectorate or because the benefit-risk ratio of a fiberoptic bronchoscopy may be not advantageous. Moreover, usual diagnostic test are not enough performant.
The current practices rely on the systematic administration of antibiotics for 7 to 10 days. The efficacy and safety of alternative diagnostic and therapeutic strategies have never been evaluated in controlled clinical trial to cure ACS.
In this context, the optimisation of the microbiological documentation of ACS might enhance the use of antimicrobial drugs, reduce their duration, and limit the emergence of multidrug resistant bacteria.
Therefore, we speculate that an early pathogen-directed strategy (respiratory broad panel multiplex PCR and early antibiotics interruption based on the PCT values decrease) might reduce the antibiotics exposure in SCD patients with ACS who are hospitalized and for whom an antibiotic treatment is indicated, as compared with usual care.
- Conditions
- Acute Chest Syndrome, Sickle Cell Disease
- Being tested
- Intervention: Combined use of a respiratory broad panel multiplex PCR and procalcitonin, Control: usual antibiotic treatment
- Keywords
- Acute chest syndrome, SCD, PCR multiplex, antibiotic treatment
- Medical subject headings
- Acute Chest Syndrome, Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention: Combined use of a respiratory broad panel multiplex PCR and procalcitoninProcedure or surgery
The actions or procedures added by the research are the realization of a nasopharyngeal swab in the two strategies, and the PCT assay at D1, D3 and D7 in the pathogen-directed strategy
Control: usual antibiotic treatmentProcedure or surgery
usual antibiotic treatment
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | usual antibiotic treatment Receives: Procedure: Control: usual antibiotic treatment |
| Intervention | Experimental | targeted antibiotic treatment according to the results of PCR multiplex Receives: Procedure: Intervention: Combined use of a respiratory broad panel multiplex PCR and procalcitonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
to compare the antibiotics exposure at 28 days (D28) after the diagnosis of ACS between the two strategies
Measured: Day 28
Secondary outcomes (9)
Rate of microbiological documentation of ACS
Measured: Day 28
Transfer to ICU at 28 days (D28) after the diagnosis of ACS between the two strategies
Measured: Day 28
Survival at 28 days
Measured: Day 28
occurrence of a secondary bacterial respiratory infection or any other secondary infection at 28 days
Measured: Day 28
Global use of antibiotics at 28 days
Measured: Day 28
Time to clinical stability at 28 days
Measured: Day 28
transfusion and exchange transfusion at 28 days
Measured: Day 28
ICU and hospital lengths of stay
Measured: Day 28
Readmission rate in hospital at 28 days
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start2 Jun 2020
- Primary completion10 Oct 2022
- Study completion10 Oct 2022
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 Acute Chest SyndromeStudies 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muriel FARTOUKH, PU-PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03919266
- Sponsor's protocol ID
- APHP180159
- Acronym
- Antibio_STA
- Status last verified
- Mar 2025
- First submitted
- 15 Apr 2019
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sabate-Elabbadi A, Mekontso-Dessap A, Lionnet F, Santin A, Verdet C, Woerther PL, Lopinto J, Turpin M, Rousseau A, Lacoste-Badie R, Razazi K, Voiriot G, Fartoukh M. Combined use of respiratory multiplex PCR and procalcitonin to reduce antibiotic exposure in sickle-cell adult patients with acute chest syndrome (The ANTIBIO-STA study): a randomised, controlled, open-label trial. Lancet Reg Health Eur. 2025 Feb 7;51:101234. doi: 10.1016/j.lanepe.2025.101234. eCollection 2025 Apr.
PubMed 39995490
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Use of a Respiratory Broad Panel Multiplex PCR and Procalcitonin to Reduce Antibiotics Exposure in Adult Patients With Sickle-cell Disease Hospitalized for Acute Chest Syndrome. A Bi-centric, Open, Parallel-group, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03919266
- Acronym / sponsor ID
- Antibio_STA / APHP180159
- Conditions
- Acute Chest Syndrome, Sickle Cell Disease
- Keywords
- Acute chest syndrome, SCD, PCR multiplex, antibiotic treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 2 Jun 2020 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 18 Apr 2019 (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.
Many patients with Sickle Cell Disease (SCD) may develop Acute Chest Syndrome (ACS). ACS is usually caused by a Lower respiratory tract infection (LRTI) which may be caused by either a bacterium or a virus. Antibiotics are usually used for 7 to 10 days with no microbiological workup.
The hypothesis of the study is that the identification of the microorganisms might lead to a reduction of antibiotics exposure and a better care of the patients.
We speculate that an early pathogen-directed strategy (respiratory broad panel multiplex PCR and early antibiotics interruption based on the PCT values decrease) might reduce the antibiotics exposure in SCD patients with ACS who are hospitalized and for whom an antibiotic treatment is indicated, as compared with usual care
Detailed description
Acute Chest Syndrome (ACS) is a frequent and severe acute complication of sickle-cell disease. It may affect 10 to 20% of hospitalized patients and is the leading cause of death. The symptoms combine a new pulmonary infiltrate and symptom(s) among fever, cough, dyspnea, expectoration, chest pain and crackles. The pathophysiology of ACS is complex and there are many interlinked aetiologies.
Lower respiratory tract infection (LRTI) is one of the most frequent aetiologies of ACS. Intracellular bacteria (Chlamydia, Mycoplasma), respiratory virus (especially respiratory syncytial virus) and pyogenes (Streptococcus pneumoniae and Staphylococcus aureus) are the most frequently identified microorganisms. Nevertheless, the clinical presentation of ACS is not helpful for the diagnosis of LRTI; the respiratory tract samples are not always collected, either because the patients do not expectorate or because the benefit-risk ratio of a fiberoptic bronchoscopy may be not advantageous. Moreover, usual diagnostic test are not enough performant.
The current practices rely on the systematic administration of antibiotics for 7 to 10 days. The efficacy and safety of alternative diagnostic and therapeutic strategies have never been evaluated in controlled clinical trial to cure ACS.
In this context, the optimisation of the microbiological documentation of ACS might enhance the use of antimicrobial drugs, reduce their duration, and limit the emergence of multidrug resistant bacteria.
Therefore, we speculate that an early pathogen-directed strategy (respiratory broad panel multiplex PCR and early antibiotics interruption based on the PCT values decrease) might reduce the antibiotics exposure in SCD patients with ACS who are hospitalized and for whom an antibiotic treatment is indicated, as compared with usual care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Procedure: Control: usual antibiotic treatmentusual antibiotic treatment |
| Intervention | Experimental | Procedure: Intervention: Combined use of a respiratory broad panel multiplex PCR and procalcitonintargeted antibiotic treatment according to the results of PCR multiplex |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Sickle Cell Disease patients with ACS with an antibiotic therapy indication
- Signed and informed consent
- Affiliated with social security
Key exclusion criteria (6 listed)
- Documented extra-pulmonary bacterial infection at the time of inclusion;
- Patients who received antibiotics for more than 24 hours before the diagnosis of ACS (during the primary hospitalization)
- Known severe immunosuppression (AIDS, neutropenia (<1000 PNN), hematology, solid tumor under chemotherapy, transplanted organ); long-term treatment with hydroxy-carbamide is not considered
- Pregnant or lactating women;
- Person deprived of liberty or under legal protection;
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 |
|---|---|---|
| Intervention: Combined use of a respiratory broad panel multiplex PCR and procalcitoninThe actions or procedures added by the research are the realization of a nasopharyngeal swab in the two strategies, and the PCT assay at D1, D3 and D7 in the pathogen-directed strategy | Procedure or surgery | Intervention |
| Control: usual antibiotic treatmentusual antibiotic treatment | Procedure or surgery | Control |
Primary outcome
to compare the antibiotics exposure at 28 days (D28) after the diagnosis of ACS between the two strategies
Time frame: Day 28
9 secondary outcomes
Rate of microbiological documentation of ACS
Time frame: Day 28
Transfer to ICU at 28 days (D28) after the diagnosis of ACS between the two strategies
Time frame: Day 28
Survival at 28 days
Time frame: Day 28
occurrence of a secondary bacterial respiratory infection or any other secondary infection at 28 days
Time frame: Day 28
Global use of antibiotics at 28 days
Time frame: Day 28
Time to clinical stability at 28 days
Time frame: Day 28
transfusion and exchange transfusion at 28 days
Time frame: Day 28
ICU and hospital lengths of stay
Time frame: Day 28
Readmission rate in hospital at 28 days
Time frame: Day 28
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 24 Mar 2025.
- Results publication: PubMed 39995490Sabate-Elabbadi A, Mekontso-Dessap A, Lionnet F, Santin A, Verdet C, Woerther PL, Lopinto J, Turpin M, Rousseau A, Lacoste-Badie R, Razazi K, Voiriot G, Fartoukh M. Combined use of respiratory multiplex PCR and procalcitonin to reduce antibiotic exposure in sickle-cell adult patients with acute chest syndrome (The ANTIBIO-STA study): a randomised, controlled, open-label trial. Lancet Reg Health Eur. 2025 Feb 7;51:101234. doi: 10.1016/j.lanepe.2025.101234. eCollection 2025 Apr.
- 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.
Muriel FARTOUKH, PU-PH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention: Combined use of a respiratory broad panel multiplex PCR and procalcitonin in people with Acute Chest Syndrome and Sickle Cell Disease, 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 4 inclusion and 6 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 24 Mar 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?
to compare the antibiotics exposure at 28 days (D28) after the diagnosis of ACS between the two strategies (time frame: Day 28). 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 NCT03919266, 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 24 Mar 2025.