Community-Acquired PneumoniaPhase 3CAT-CAPNCT05903352
Customized Antibiotic Treatment Duration Among Hospitalized Patients With Moderately Severe Community-Acquired Pneumonia
A Phase 3 study testing Stop antibiotic and Continue the antimicrobial treatment in people with Community-Acquired Pneumonia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The primary objective of the study is to evaluate if the efficacy of an experimental strategy on antibiotic treatment duration based on stopping treatment when stability criteria are reached after at least 48 h of treatment, is non-inferior to the efficacy of standard antibiotic duration in CAP patients treated in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-Acquired Pneumonia
- What is being tested?
- Stop antibiotic and Continue the antimicrobial treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 328 participants
- Where
- 1 siteFrance
- Study dates
- 5 Feb 2024to May 2027
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient (≥18 years old)
- Admitted to hospital for suspected CAP defined by the presence of at least 2 of the following diagnostic clinical criteria:
- Fever (temperature > 38°C) or hypothermia (< 36°C)
- Dyspnea
- Cough
- Production of purulent sputum
Show all 21Show fewer
- Crackles
- Radiological evidence of a new infiltrate (chest X-ray or CT scan)
- Negative viral respiratory testing
- Treated for a minimum of 48 hours with antibiotics (excluding azithromycin due to its prolonged half-life)Presenting with an early clinical response within the last 24 hours (up to 7 days after the start of antibiotic treatment, if planned treatment duration > 7 days), defined by the presence of all the following criteria:apyrexia (T°C ≤ 37.8)heart rate < 100/minrespiratory rate < 24/min, according to the patient's usual mode of oxygenation,arterial oxygen saturation ≥ 92%, according to the patient's usual mode of oxygenation,Patient currently under antibiotic treatment for his suspected CAP (i.e. the last dose of ATB has been administered to the patient less than 24 hours ago)
- Patient presenting a clinical response within the last 24 hours defined by the presence of all the following criteria:
- apyrexia (T°C ≤ 37.8)
- heart rate < 100/min
- respiratory rate < 24/min, according to the patient's usual mode of oxygenation,
- arterial oxygen saturation ≥ 92%, according to the patient's usual mode of oxygenation,
- systolic blood pressure ≥ 90mmHg, The last occurring of these criteria must have appeared within the last 24 hours.
- The antibiotic treatment for suspected CAP has started at least 48 hours ago and at most 6 days ago
- No other site of infection besides respiratory
- Affiliated to Health insurance
- Has given informed consent
- Patient understanding oral and written French, or presence of a relative who can explain and help him complete the study documents
Who cannot join
- Signs of severe CAP (abscess, massive pleural effusion, serious chronic respiratory insufficiency)
- Known immunosuppression (asplenia, neutropenia, agammaglobulinemia, transplant, myeloma, lymphoma, known HIV and CD4<200/mm3)
- Suspected or confirmed legionellosis
- Any other infection necessitating concomitant antibiotic treatment
- Confirmed or suspected aspiration pneumonia or healthcare-associated pneumonia
- Treatment of suspected CAP with azithromycin (due to its prolonged half-life)
Show all 13Show fewer
- Concomitant steroid treatment (only for patients treated with fluoroquinolones antibiotics)
- Pre-existing aortic aneurysm or dissection, family history of aortic aneurysm or dissection, Marfan syndrome, Ehlers-Danlos syndrome, Takayasu arthritis, uncontrolled arterial hypertension, atherosclerosis (only for patients treated with fluoroquinolones antibiotics)
- Pregnant or breastfeeding woman
- Life expectancy < 1 month
- Patient under legal guardianship (French "tutelle" or "curatelle")
- Patient without fixed address
- Patient enrolled in another interventional clinical trial on CAP treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Infectious diseases department, Raymond-Poincaré Hospital - APHP
Garches, 92380
About this study
The primary objective of the study is to evaluate if the efficacy of an experimental strategy on antibiotic treatment duration based on stopping treatment when stability criteria are reached after at least 48 h of treatment, is non-inferior to the efficacy of standard antibiotic duration in CAP patients treated in the hospital setting.
As the secondary objectives, the study aims
- To study if the efficacy of our experimental strategy on antibiotic treatment duration compared to standard of care in CAP patients treated in the hospital setting is non-inferior in terms of:
- Persistence of cure at Day 30 of antibiotic treatment
- All-cause mortality rate on Day 30 of antibiotic treatment
- Patients evolution of pneumonia symptoms and quality of life via 2 scores (CAP score, CAP Sym) at Day 0 of treatment (retrospectively), at stability (Day S), at Day 7 , at Day 15, and at Day 30 of antibiotic treatment.
- To compare between the 2 study arms at Day 30 of antibiotic treatment:
- The duration of antibiotic treatment;
- The length of hospital stay;
- The frequency and severity of adverse events during the 30 days after the start of treatment.
- To explore the impact of reduced antibiotic treatment duration for CAP on the oropharyngeal resistome.
Read the detailed description
Recent studies have suggested that community-acquired pneumonia (CAP) can be successfully treated with short-course antibiotic regimen when clinical improvement is rapidly obtained. Even if clinical response is obtained in 3 days in the majority of cases, it can vary widely among patients suggesting "one duration does not fit all". An individualised duration of therapy depending on the patient's response could help to ensure bacterial eradication while avoiding unnecessary antibiotic exposure and thus reduce antibiotic resistance. At present, this strategy has never been tested.
This is a phase III, pragmatic, non-inferiority randomised (1:1) national multicentre trial. Population of study participants will be patients admitted to hospital with suspected CAP and in need for antibiotics.
There is no need to establish a DSMB for this trial. The antibiotic treatments prescribed during this study are treatments used in current practice, with well-known adverse drug reactions. Furthermore, a 3-day treatment duration has already been studied in 2 previous randomized clinical trials, showing its safety for hospitalized CAP.
Statistical analysis:
Statistical inference for non-inferiority will be based on the confidence intervals (CI) of the difference in Day 15 cure proportions [proportion in reference arm - proportion in experimental arm] accounting for randomisation stratification factors (centre and delay from Day 0 to Day S (≤ 3 days or > 3 days).
The inferiority hypothesis will be rejected and non-inferiority will be claimed if the upper bound of the 95%CI of the difference is ≤ 10%.
Secondary efficacy endpoints evaluating the evolution of symptoms will be analysed using either a GMM or a GEE for categorical and continuous variables, respectively.
Other quantitative variables will be compared using the Student t-test (or a non-parametric test if the distribution remains skewed following transformation), while categorical variables will be analysed using either the Chi-squared or the Fisher-exact tests.
All statistical tests will be performed with a level of significance of 5%, except the primary endpoint which be analysed with a 2.5% level of significance.
- Conditions
- Community-Acquired Pneumonia
- Being tested
- Stop antibiotic, Continue the antimicrobial treatment
- Keywords
- Community-Acquired Pneumonia, Antibiotic treatment duration, Antibiotic resistance, Infectious diseases
- Medical subject headings
- Community-Acquired Pneumonia, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stop antibioticOther
Stop the antibiotic treatment on day S (stability criteria reached for 24 h or within 48 hours after the start of antibiotic treatment).
Continue the antimicrobial treatmentDrug
Continue the antimicrobial treatment for a duration predetermined by the investigator (usual practice, at least 5 days of treatment in total).
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic treatment | Placebo comparator | Antibiotic treatment duration left to the physician's judgment (usual practice: total treatment duration between 5 to 10 days according to French guidelines; more than 7 days of treatment should be justified). Receives: Drug: Continue the antimicrobial treatment |
| Interruption of treatment | Experimental | Interruption of treatment based on the patient reaching all of the following stability criteria (body temperature ≤ 37.8°C; heart rate ≤ 100/min; systolic blood pressure > 90mmHg; oxygen saturation ≥ 92%; respiratory rate < 24/min; normal mental status (27)), with a treatment duration no shorter than 48 h. Receives: Other: Stop antibiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of cure at Day 15 after treatment initiation
Cure at Day 15 will be defined by the association of:
- Persistence of stability criteria (body temperature ≤ 37.8°C; heart rate ≤ 100/min; systolic blood pressure > 90mmHg; oxygen saturation ≥ 92%; respiratory rate < 24/min; normal mental status);
- No additional antibiotic treatment, targeting CAP, taken after the end of initial antibiotic treatment.
Patients who died, or are not cured as defined above, will be classified as failure at Day 15.
Measured: Day 15
Secondary outcomes (9)
Rate of cure at Day 30
Rate of cure at Day 30 after the start of treatment defined by the association of: persistence of stability criteria (body temperature ≤ 37.8°C; heart rate ≤ 100/min; systolic blood pressure > 90mmHg; O2 saturation ≥ 92%; respiratory rate < 24/min; normal mental status); absence of additional antibiotic treatment needed after the end of initial antibiotic treatment.
Measured: Day 30
Mortality on Day 30
All-cause mortality on Day 30 after the start of antibiotic treatment.
Measured: Day 30
Patients' evolution of pneumonia symptoms
Patients' evolution of pneumonia symptoms by CAP Score at Day 0 of treatment (retrospectively), at stability (Day S), at Day 7, at Day 15, and at Day 30 of antibiotic treatment.
Measured: Day-0, Day S, Day 7, at Day 15, and at Day 30
Patients' evolution of pneumonia symptoms
Patients' evolution of pneumonia symptoms and quality of life by CAP Sym:
validated self-questionnaires filled at Day 0 of treatment (retrospectively), at stability (Day S), at Day 7, at Day 15, and at Day 30 of antibiotic treatment.
Measured: Day 15 and Day 30
Duration of antibiotic treatment targeting CAP
Duration of antibiotic treatment targeting CAP during the 30 days after the start of treatment.
Measured: Day 30
Duration of antibiotic treatment for all indications
Duration of antibiotic treatment for all indications during the 30 days after the start of treatment.
Measured: Day 30
Length of hospitalization
Length of initial hospital stay
Measured: Day 30
Incidence of adverse event
Frequency and severity of adverse events during the 30 days after the start of treatment
Measured: Day 30
Number of resistance genes
Calculating for each patient, the number of resistance genes normalised against the quantity of total bacterial DNA, the bacterial richness and diversity, among 300 patients.
Measured: Day S and Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start5 Feb 2024
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
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 Community-Acquired PneumoniaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All eligible patients with confirmed CAP and willing to participate will be included and randomly assigned (1:1 ratio) by the investigator, to either continue the antimicrobial treatment for a duration predetermined by the investigator (usual practice, at least 3 days of treatment in total), or to stop the antibiotic treatment.
- Masking
- None (open label)
- Enrolment
- 328 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurélien Dihn, MD, PhD, Principal investigator, Infectious diseases department, Raymond-Poincaré Hospital - APHPJacques Ropers, PharmD, Study director, Clinical Research Unit Pitié Salpêtrière - Charles Foix, CHU La Pitié-Salpêtrière - APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05903352
- Sponsor's protocol ID
- APHP220814
- Other IDs
- 2023-504208-27-00, 2023
- Acronym
- CAT-CAP
- Status last verified
- Mar 2025
- First submitted
- 6 Jun 2023
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dinh A, Ropers J, Duran C, Davido B, Deconinck L, Matt M, Senard O, Lagrange A, Makhloufi S, Mellon G, de Lastours V, Bouchand F, Mathieu E, Kahn JE, Rouveix E, Grenet J, Dumoulin J, Chinet T, Pepin M, Delcey V, Diamantis S, Benhamou D, Vitrat V, Dombret MC, Renaud B, Perronne C, Claessens YE, Labarere J, Bedos JP, Aegerter P, Cremieux AC; Pneumonia Short Treatment (PTC) Study Group. Discontinuing beta-lactam treatment after 3 days for patients with community-acquired pneumonia in non-critical care wards (PTC): a double-blind, randomised, placebo-controlled, non-inferiority trial. Lancet. 2021 Mar 27;397(10280):1195-1203. doi: 10.1016/S0140-6736(21)00313-5.
PubMed 33773631
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Customized Antibiotic Treatment Duration Among Hospitalized Patients With Moderately Severe Community-Acquired Pneumonia
- ClinicalTrials.gov ID
- NCT05903352
- Acronym / sponsor ID
- CAT-CAP / APHP220814
- Conditions
- Community-Acquired Pneumonia
- Keywords
- Community-Acquired Pneumonia, Antibiotic treatment duration, Antibiotic resistance, Infectious diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 328 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 15 Jun 2023 (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 primary objective of the study is to evaluate if the efficacy of an experimental strategy on antibiotic treatment duration based on stopping treatment when stability criteria are reached after at least 48 h of treatment, is non-inferior to the efficacy of standard antibiotic duration in CAP patients treated in the hospital setting.
As the secondary objectives, the study aims
- To study if the efficacy of our experimental strategy on antibiotic treatment duration compared to standard of care in CAP patients treated in the hospital setting is non-inferior in terms of:
- Persistence of cure at Day 30 of antibiotic treatment
- All-cause mortality rate on Day 30 of antibiotic treatment
- Patients evolution of pneumonia symptoms and quality of life via 2 scores (CAP score, CAP Sym) at Day 0 of treatment (retrospectively), at stability (Day S), at Day 7 , at Day 15, and at Day 30 of antibiotic treatment.
- To compare between the 2 study arms at Day 30 of antibiotic treatment:
- The duration of antibiotic treatment;
- The length of hospital stay;
- The frequency and severity of adverse events during the 30 days after the start of treatment.
- To explore the impact of reduced antibiotic treatment duration for CAP on the oropharyngeal resistome.
Detailed description
Recent studies have suggested that community-acquired pneumonia (CAP) can be successfully treated with short-course antibiotic regimen when clinical improvement is rapidly obtained. Even if clinical response is obtained in 3 days in the majority of cases, it can vary widely among patients suggesting "one duration does not fit all". An individualised duration of therapy depending on the patient's response could help to ensure bacterial eradication while avoiding unnecessary antibiotic exposure and thus reduce antibiotic resistance. At present, this strategy has never been tested.
This is a phase III, pragmatic, non-inferiority randomised (1:1) national multicentre trial. Population of study participants will be patients admitted to hospital with suspected CAP and in need for antibiotics.
There is no need to establish a DSMB for this trial. The antibiotic treatments prescribed during this study are treatments used in current practice, with well-known adverse drug reactions. Furthermore, a 3-day treatment duration has already been studied in 2 previous randomized clinical trials, showing its safety for hospitalized CAP.
Statistical analysis:
Statistical inference for non-inferiority will be based on the confidence intervals (CI) of the difference in Day 15 cure proportions [proportion in reference arm - proportion in experimental arm] accounting for randomisation stratification factors (centre and delay from Day 0 to Day S (≤ 3 days or > 3 days).
The inferiority hypothesis will be rejected and non-inferiority will be claimed if the upper bound of the 95%CI of the difference is ≤ 10%.
Secondary efficacy endpoints evaluating the evolution of symptoms will be analysed using either a GMM or a GEE for categorical and continuous variables, respectively.
Other quantitative variables will be compared using the Student t-test (or a non-parametric test if the distribution remains skewed following transformation), while categorical variables will be analysed using either the Chi-squared or the Fisher-exact tests.
All statistical tests will be performed with a level of significance of 5%, except the primary endpoint which be analysed with a 2.5% level of significance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All eligible patients with confirmed CAP and willing to participate will be included and randomly assigned (1:1 ratio) by the investigator, to either continue the antimicrobial treatment for a duration predetermined by the investigator (usual practice, at least 3 days of treatment in total), or to stop the antibiotic treatment.
| Arm | Type | Receives |
|---|---|---|
| Antibiotic treatment | Placebo comparator | Drug: Continue the antimicrobial treatmentAntibiotic treatment duration left to the physician's judgment (usual practice: total treatment duration between 5 to 10 days according to French guidelines; more than 7 days of treatment should be justified). |
| Interruption of treatment | Experimental | Other: Stop antibioticInterruption of treatment based on the patient reaching all of the following stability criteria (body temperature ≤ 37.8°C; heart rate ≤ 100/min; systolic blood pressure > 90mmHg; oxygen saturation ≥ 92%; respiratory rate < 24/min; normal mental status (27)), with a treatment duration no shorter than 48 h. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Adult patient (≥18 years old)
- Admitted to hospital for suspected CAP defined by the presence of at least 2 of the following diagnostic clinical criteria:
- Radiological evidence of a new infiltrate (chest X-ray or CT scan)
- Negative viral respiratory testing
- Treated for a minimum of 48 hours with antibiotics (excluding azithromycin due to its prolonged half-life)Presenting with an early clinical response within the last 24 hours (up to 7 days after the start of antibiotic treatment, if planned treatment duration > 7 days), defined by the presence of all the following criteria:apyrexia (T°C ≤ 37.8)heart rate < 100/minrespiratory rate < 24/min, according to the patient's usual mode of oxygenation,arterial oxygen saturation ≥ 92%, according to the patient's usual mode of oxygenation,Patient currently under antibiotic treatment for his suspected CAP (i.e. the last dose of ATB has been administered to the patient less than 24 hours ago)
Key exclusion criteria (13 listed)
- Signs of severe CAP (abscess, massive pleural effusion, serious chronic respiratory insufficiency)
- Known immunosuppression (asplenia, neutropenia, agammaglobulinemia, transplant, myeloma, lymphoma, known HIV and CD4<200/mm3)
- Suspected or confirmed legionellosis
- Any other infection necessitating concomitant antibiotic treatment
- Confirmed or suspected aspiration pneumonia or healthcare-associated pneumonia
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 |
|---|---|---|
| Stop antibioticStop the antibiotic treatment on day S (stability criteria reached for 24 h or within 48 hours after the start of antibiotic treatment). | Other | Interruption of treatment |
| Continue the antimicrobial treatmentContinue the antimicrobial treatment for a duration predetermined by the investigator (usual practice, at least 5 days of treatment in total). | Drug | Antibiotic treatment |
Primary outcome
Rate of cure at Day 15 after treatment initiation
Time frame: Day 15
Cure at Day 15 will be defined by the association of: * Persistence of stability criteria (body temperature ≤ 37.8°C; heart rate ≤ 100/min; systolic blood pressure > 90mmHg; oxygen saturation ≥ 92%; respiratory rate < 24/min; normal mental status); * No additional antibiotic treatment, targeting CAP, taken after the end of initial antibiotic treatment. Patients who died, or are not cured as defined above, will be classified as failure at Day 15.
9 secondary outcomes
Rate of cure at Day 30
Time frame: Day 30
Mortality on Day 30
Time frame: Day 30
Patients' evolution of pneumonia symptoms
Time frame: Day-0, Day S, Day 7, at Day 15, and at Day 30
Patients' evolution of pneumonia symptoms
Time frame: Day 15 and Day 30
Duration of antibiotic treatment targeting CAP
Time frame: Day 30
Duration of antibiotic treatment for all indications
Time frame: Day 30
Length of hospitalization
Time frame: Day 30
Incidence of adverse event
Time frame: Day 30
Number of resistance genes
Time frame: Day S and Day 30
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 20 Mar 2025.
- Background: PubMed 33773631Dinh A, Ropers J, Duran C, Davido B, Deconinck L, Matt M, Senard O, Lagrange A, Makhloufi S, Mellon G, de Lastours V, Bouchand F, Mathieu E, Kahn JE, Rouveix E, Grenet J, Dumoulin J, Chinet T, Pepin M, Delcey V, Diamantis S, Benhamou D, Vitrat V, Dombret MC, Renaud B, Perronne C, Claessens YE, Labarere J, Bedos JP, Aegerter P, Cremieux AC; Pneumonia Short Treatment (PTC) Study Group. Discontinuing beta-lactam treatment after 3 days for patients with community-acquired pneumonia in non-critical care wards (PTC): a double-blind, randomised, placebo-controlled, non-inferiority trial. Lancet. 2021 Mar 27;397(10280):1195-1203. doi: 10.1016/S0140-6736(21)00313-5.
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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.
Aurélien Dihn, MD, PhD principal investigator
Infectious diseases department, Raymond-Poincaré Hospital - APHP
Jacques Ropers, PharmD study director
Clinical Research Unit Pitié Salpêtrière - Charles Foix, CHU La Pitié-Salpêtrière - APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Stop antibiotic and Continue the antimicrobial treatment in people with Community-Acquired Pneumonia, 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 21 inclusion and 13 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 20 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Aurélien Dinh, MD, PhD (+ 33 (0)1 47 10 44 32, aurelien.dinh@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of cure at Day 15 after treatment initiation (time frame: Day 15). 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 NCT05903352, 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 20 Mar 2025.