Ventilator-Associated PneumoniaECTOPICUSNCT03018431
CT Scan and Lung Ultrasonography to Improve Diagnostic of Ventilation Acquired Pneumonia in ICU
An observational study of Ventilator-Associated Pneumonia and Tracheobronchitis, run by Centre Hospitalier Universitaire de Besancon at 2 sites in France.
Trial summary
We aim to show that systematic ultrasonography performed in ventilated patients suspected of ventilation-acquired pneumonia could improve the accuracy of diagnostic of pneumonia, and helps defining the diagnostic of tracheobronchitis when lower respiratory tract infection is considered. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator-Associated Pneumonia, Tracheobronchitis
- What is being tested?
- CT Scan
- How many people
- 160 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Oct 2017to Jun 2019
- How long will I take part?
- 18 Days
- Phase
- Observational
- 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
Study population: Every patient place under mechanical ventilation at least for 48 hours, suspected of lower respiratory tract infection, based on CDC criterias of ventilatior-acquired pneumonia.
Who may be able to join
- Immunocompetent subject,
- fever and/or purulent tracheal secretions and/or hyperleukocytosis or leukopenia, associated with a positive microbiological sample (within broncho-alveolar leakage, endotracheal aspiration, or distal sample),
- invasive mechanical ventilation initiated since at least 48hours, and suppose to be maintained for at least 48hours
Who cannot join
- Immunocompromised-patients defined by ; HIV treated or not, patient under corticotherapy, immunotherapy, inflammatory systemic diseases, solid organ transplant, solid tumor treated or not, bone marrow transplant or stem cells graft, hematological malignancy known or under treatment,
- moribond,
- ventilation expected to last less than 48hours,
- minor-aged patients,
- no social insurance or isolation,
- mental disability making the understanding of the purpose of too difficult.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Universitaire Jean Minjoz
Besançon, Doubs, 25030
Paul-Henri WICKY, 003680129209, phwicky@outook.fr
Hôpital Bichat - Claude Bernard
Paris, 75 018
About this study
Official title: Impact of CT Scan and Lung Ultrasonogrpahy in Early Diagnostic Accuracy for Ventilation Acquired Lower Respiratory Tract Infections in Intensive Care Units.
We aim to show that systematic ultrasonography performed in ventilated patients suspected of ventilation-acquired pneumonia could improve the accuracy of diagnostic of pneumonia, and helps defining the diagnostic of tracheobronchitis when lower respiratory tract infection is considered.
Chest CT scan is often performed before or just after admission in ICU, and usually show abnormalities that are revealed later on standard radiographs.
Read more
This last exam is traditionally considered as the gold standard to prove new pulmonary infiltrates, but the correlation with parenchymal consolidation is pretty low, and lead to over-diagnosing pneumonia, thus leading to a massive and maybe sometimes unconsidered prescription of antibiotic therapy.
Lung ultrasonography conducted systematically within the 3 first days after suspcion of pneumonia could help making the difference between real infection-linked lesions, and banal abnormalities following the hydric inflation of intra-thoracic organs, for instance pulmonary edema or pleural effusion.
An independent evaluation using lung ultrasound, and analysis of CT scan acquisition when performed, compared with the physician in charge of the patient appreciation by suggesting him to provide his own probability of pneumonia upon routine clinical and biological datas.
Read the detailed description
Diagnostic of VAP and tracheobronchitis is often difficult in UC under mechanical ventilation, and usually occuring quite early after initial phase of hemodynamic instability, and characterized by needs of massive fluids supports and drugs infusion. The goldstandard is still standard chest X-ray, providing a picture of the whole abnormalities due to cardiac failure, and cardiogenic pulmonary edema. The high rate of water in chest of the patients under ventilation assistance and hemodynamic support is responsible of a misinterpretation of the abnormalities visualized on the radiographs. It is often considered that Lung ultrasonography is useful to appreciate the involvement of pleural effusion, explaning etiologies of hypoxemia, where cardiac failure is excluded by the simultaneous ultrasonographic evaluation. However, it is not well recognized that pulmonary parenchyma can be explored through echography, and that it provides a lot of information about the amount of liquid inside it, and the default of aeration. Thus, it can in real time help the physician to guide the therapeutics and manage the ventilation better. Moreover, the suspicion of infection, clinically and biologically leads to the early prescription of antibiotics, given that the radiography is abnormal. Knowing that there is now parenchymal consolidation but rather effusion or a certain degree of pulmonary edema could help avoiding treating falsely a respiratory infection.
The same thoughts can be held concerning Chest CT Scan, an exam often realized at the early stage of management in a critical situation. We can take for granted that when occurring in the 48 first hours of resuscitation, this exam shows in a certain number of cases preexisting abnormalities, that are revealed severla hours later by Chest radiograph, when the suspicion of respiratory infection acquired under ventilation emerge. If we take into account that these abnormalities seen on radiographs are just correlated to those that could be seen on CT, but with a certain delay, and are not de novo, it could lead to an overestimating of ventilation acquired pneumonia, because the criteria of a new radiographic infiltrate won't be valid anymore. The diagnostic of tracheobronchitis could then be more appropriated in a certain number of situations.
Our aim is to verify retrospectively by an adjudication committee, that this early CT Scan, within the 2 first days after admission if patient is ventilated and/or suspicion of lower respiratory tract infection, and a systematic lung ultrasonographic evaluation, provided by an independent operator, could change our appreciation of the frequency of ventilation-acquired pneumonia, comparing to the appreciation of th physician in charge of the patients.
We are thus conducting a repeated evaluation, at day 0, day 3 and day 7 with ultrasonography, in order to give a probability of pneumonia or tracheobronchitis by the echographist operator, and suggesting the physician to give his own probability based on clinical and biological routine datas. We then measure the rate of agreement between the two parts, to see how far the systematic evaluation using pleural ultrasonography could help defining the probability of infection, and validating the diagnostic of pneumonia. The impact should be to improve the accuracy within the first days 2 or 3 days after suspicion, when repeated, if possible by the same operator. One of the main benefit could be the reduction or better reevaluation of antibiotic therapy, if diagnostic of pneumonia is rejected secondary, eventually shorter course of treatment could be chosen, even if this point deserve to be evaluated in further studies.
- Conditions
- Ventilator-Associated Pneumonia, Tracheobronchitis
- Being tested
- CT Scan
- Keywords
- Lung ultrasonography, Chest CT scan, ventilator-associated pneumonia, ventilator-associated tracheobronchitis, antibiotic stewardship
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT ScanOther
Also called Ultrasonography
patients undergoing chest CT scan at admission and repeated lung ultrasonography
| Study group | Role | What they receive |
|---|---|---|
| Physician routine evaluation | systematic evaluation of the probability of tracheobronchitis or pneumonia based upon clinical and biological, associated with standard radiographs, performed by the physician in chrage of the patient. | |
| independent evaluation | systematic evaluation of the probability of tracheobronchitis or pneumonia based upon early CT scan, and repeated lung ultrasonography, performed by an independent operator. Receives: Other: CT Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance of diagnostic of tracheo-bronchitis or pneumonia under mechanical ventilation, between physician in charge and independent observator cunducting ultrasound and CT scan evaluation.
Measured: 8 days
Secondary outcomes (2)
rate of agreement between radiographs, CT scan and lung ultrasonography
Measured: 8 days
correlation between evolution according to management of infection and misdiagnostic of pneumonia or tracheo-bronchitis or not by the clinician.
improving under treatment or worsening without antibiotic therapy when pneumonia diagnostic is valid or not, making further considering the management of antibiotic therapy by the physician guided by CT scan and/or ultrasonography.
quantifying amount of situations when diagnostic of pneumonia is validated retrospectively by the adjudication, and delayed starting of antibiotics when diagnostic is not patent early in the standard evaluation, thus conducting to an increased risk of morbi-mortality.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study start15 Oct 2017 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ventilator-Associated PneumoniaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
- Target duration
- 18 Days
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul-Henri WICKY, Centre Hospitalier Universitaire de Besancon
- Investigators
- Lila Bouadma, MD,PhD, Study director, Hôpital universitaire Bichat- Claude Bernard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03018431
- Sponsor's protocol ID
- CHBesançon
- Acronym
- ECTOPICUS
- Status last verified
- Sep 2017
- First submitted
- 10 Jan 2017
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Haddam M, Zieleskiewicz L, Perbet S, Baldovini A, Guervilly C, Arbelot C, Noel A, Vigne C, Hammad E, Antonini F, Lehingue S, Peytel E, Lu Q, Bouhemad B, Golmard JL, Langeron O, Martin C, Muller L, Rouby JJ, Constantin JM, Papazian L, Leone M; CAR'Echo Collaborative Network; AzuRea Collaborative Network. Lung ultrasonography for assessment of oxygenation response to prone position ventilation in ARDS. Intensive Care Med. 2016 Oct;42(10):1546-1556. doi: 10.1007/s00134-016-4411-7. Epub 2016 Jun 20.
PubMed 27324241Mongodi S, Via G, Girard M, Rouquette I, Misset B, Braschi A, Mojoli F, Bouhemad B. Lung Ultrasound for Early Diagnosis of Ventilator-Associated Pneumonia. Chest. 2016 Apr;149(4):969-80. doi: 10.1016/j.chest.2015.12.012. Epub 2015 Dec 22.
PubMed 26836896Martin-Loeches I, Povoa P, Rodriguez A, Curcio D, Suarez D, Mira JP, Cordero ML, Lepecq R, Girault C, Candeias C, Seguin P, Paulino C, Messika J, Castro AG, Valles J, Coelho L, Rabello L, Lisboa T, Collins D, Torres A, Salluh J, Nseir S; TAVeM study. Incidence and prognosis of ventilator-associated tracheobronchitis (TAVeM): a multicentre, prospective, observational study. Lancet Respir Med. 2015 Nov;3(11):859-68. doi: 10.1016/S2213-2600(15)00326-4. Epub 2015 Oct 22.
PubMed 26472037Claessens YE, Debray MP, Tubach F, Brun AL, Rammaert B, Hausfater P, Naccache JM, Ray P, Choquet C, Carette MF, Mayaud C, Leport C, Duval X. Early Chest Computed Tomography Scan to Assist Diagnosis and Guide Treatment Decision for Suspected Community-acquired Pneumonia. Am J Respir Crit Care Med. 2015 Oct 15;192(8):974-82. doi: 10.1164/rccm.201501-0017OC.
PubMed 26168322
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of CT Scan and Lung Ultrasonogrpahy in Early Diagnostic Accuracy for Ventilation Acquired Lower Respiratory Tract Infections in Intensive Care Units.
- ClinicalTrials.gov ID
- NCT03018431
- Acronym / sponsor ID
- ECTOPICUS / CHBesançon
- Conditions
- Ventilator-Associated Pneumonia, Tracheobronchitis
- Keywords
- Lung ultrasonography, Chest CT scan, ventilator-associated pneumonia, ventilator-associated tracheobronchitis, antibiotic stewardship
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 15 Oct 2017 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 12 Jan 2017 (estimated)
- 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.
We aim to show that systematic ultrasonography performed in ventilated patients suspected of ventilation-acquired pneumonia could improve the accuracy of diagnostic of pneumonia, and helps defining the diagnostic of tracheobronchitis when lower respiratory tract infection is considered.
Chest CT scan is often performed before or just after admission in ICU, and usually show abnormalities that are revealed later on standard radiographs.
This last exam is traditionally considered as the gold standard to prove new pulmonary infiltrates, but the correlation with parenchymal consolidation is pretty low, and lead to over-diagnosing pneumonia, thus leading to a massive and maybe sometimes unconsidered prescription of antibiotic therapy.
Lung ultrasonography conducted systematically within the 3 first days after suspcion of pneumonia could help making the difference between real infection-linked lesions, and banal abnormalities following the hydric inflation of intra-thoracic organs, for instance pulmonary edema or pleural effusion.
An independent evaluation using lung ultrasound, and analysis of CT scan acquisition when performed, compared with the physician in charge of the patient appreciation by suggesting him to provide his own probability of pneumonia upon routine clinical and biological datas.
Detailed description
Diagnostic of VAP and tracheobronchitis is often difficult in UC under mechanical ventilation, and usually occuring quite early after initial phase of hemodynamic instability, and characterized by needs of massive fluids supports and drugs infusion. The goldstandard is still standard chest X-ray, providing a picture of the whole abnormalities due to cardiac failure, and cardiogenic pulmonary edema. The high rate of water in chest of the patients under ventilation assistance and hemodynamic support is responsible of a misinterpretation of the abnormalities visualized on the radiographs. It is often considered that Lung ultrasonography is useful to appreciate the involvement of pleural effusion, explaning etiologies of hypoxemia, where cardiac failure is excluded by the simultaneous ultrasonographic evaluation. However, it is not well recognized that pulmonary parenchyma can be explored through echography, and that it provides a lot of information about the amount of liquid inside it, and the default of aeration. Thus, it can in real time help the physician to guide the therapeutics and manage the ventilation better. Moreover, the suspicion of infection, clinically and biologically leads to the early prescription of antibiotics, given that the radiography is abnormal. Knowing that there is now parenchymal consolidation but rather effusion or a certain degree of pulmonary edema could help avoiding treating falsely a respiratory infection.
The same thoughts can be held concerning Chest CT Scan, an exam often realized at the early stage of management in a critical situation. We can take for granted that when occurring in the 48 first hours of resuscitation, this exam shows in a certain number of cases preexisting abnormalities, that are revealed severla hours later by Chest radiograph, when the suspicion of respiratory infection acquired under ventilation emerge. If we take into account that these abnormalities seen on radiographs are just correlated to those that could be seen on CT, but with a certain delay, and are not de novo, it could lead to an overestimating of ventilation acquired pneumonia, because the criteria of a new radiographic infiltrate won't be valid anymore. The diagnostic of tracheobronchitis could then be more appropriated in a certain number of situations.
Our aim is to verify retrospectively by an adjudication committee, that this early CT Scan, within the 2 first days after admission if patient is ventilated and/or suspicion of lower respiratory tract infection, and a systematic lung ultrasonographic evaluation, provided by an independent operator, could change our appreciation of the frequency of ventilation-acquired pneumonia, comparing to the appreciation of th physician in charge of the patients.
We are thus conducting a repeated evaluation, at day 0, day 3 and day 7 with ultrasonography, in order to give a probability of pneumonia or tracheobronchitis by the echographist operator, and suggesting the physician to give his own probability based on clinical and biological routine datas. We then measure the rate of agreement between the two parts, to see how far the systematic evaluation using pleural ultrasonography could help defining the probability of infection, and validating the diagnostic of pneumonia. The impact should be to improve the accuracy within the first days 2 or 3 days after suspicion, when repeated, if possible by the same operator. One of the main benefit could be the reduction or better reevaluation of antibiotic therapy, if diagnostic of pneumonia is rejected secondary, eventually shorter course of treatment could be chosen, even if this point deserve to be evaluated in further studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physician routine evaluation | – | –systematic evaluation of the probability of tracheobronchitis or pneumonia based upon clinical and biological, associated with standard radiographs, performed by the physician in chrage of the patient. |
| independent evaluation | – | Other: CT Scansystematic evaluation of the probability of tracheobronchitis or pneumonia based upon early CT scan, and repeated lung ultrasonography, performed by an independent operator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Every patient place under mechanical ventilation at least for 48 hours, suspected of lower respiratory tract infection, based on CDC criterias of ventilatior-acquired pneumonia.
Key inclusion criteria (3 listed)
- Immunocompetent subject,
- fever and/or purulent tracheal secretions and/or hyperleukocytosis or leukopenia, associated with a positive microbiological sample (within broncho-alveolar leakage, endotracheal aspiration, or distal sample),
- invasive mechanical ventilation initiated since at least 48hours, and suppose to be maintained for at least 48hours
Key exclusion criteria (6 listed)
- Immunocompromised-patients defined by ; HIV treated or not, patient under corticotherapy, immunotherapy, inflammatory systemic diseases, solid organ transplant, solid tumor treated or not, bone marrow transplant or stem cells graft, hematological malignancy known or under treatment,
- moribond,
- ventilation expected to last less than 48hours,
- minor-aged patients,
- no social insurance or isolation,
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 |
|---|---|---|
| CT ScanAlso: Ultrasonographypatients undergoing chest CT scan at admission and repeated lung ultrasonography | Other | independent evaluation |
Primary outcome
Concordance of diagnostic of tracheo-bronchitis or pneumonia under mechanical ventilation, between physician in charge and independent observator cunducting ultrasound and CT scan evaluation.
Time frame: 8 days
2 secondary outcomes
rate of agreement between radiographs, CT scan and lung ultrasonography
Time frame: 8 days
correlation between evolution according to management of infection and misdiagnostic of pneumonia or tracheo-bronchitis or not by the clinician.
Time frame: 8 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
- Results publication: PubMed 27324241Haddam M, Zieleskiewicz L, Perbet S, Baldovini A, Guervilly C, Arbelot C, Noel A, Vigne C, Hammad E, Antonini F, Lehingue S, Peytel E, Lu Q, Bouhemad B, Golmard JL, Langeron O, Martin C, Muller L, Rouby JJ, Constantin JM, Papazian L, Leone M; CAR'Echo Collaborative Network; AzuRea Collaborative Network. Lung ultrasonography for assessment of oxygenation response to prone position ventilation in ARDS. Intensive Care Med. 2016 Oct;42(10):1546-1556. doi: 10.1007/s00134-016-4411-7. Epub 2016 Jun 20.
- Results publication: PubMed 26836896Mongodi S, Via G, Girard M, Rouquette I, Misset B, Braschi A, Mojoli F, Bouhemad B. Lung Ultrasound for Early Diagnosis of Ventilator-Associated Pneumonia. Chest. 2016 Apr;149(4):969-80. doi: 10.1016/j.chest.2015.12.012. Epub 2015 Dec 22.
- Results publication: PubMed 26472037Martin-Loeches I, Povoa P, Rodriguez A, Curcio D, Suarez D, Mira JP, Cordero ML, Lepecq R, Girault C, Candeias C, Seguin P, Paulino C, Messika J, Castro AG, Valles J, Coelho L, Rabello L, Lisboa T, Collins D, Torres A, Salluh J, Nseir S; TAVeM study. Incidence and prognosis of ventilator-associated tracheobronchitis (TAVeM): a multicentre, prospective, observational study. Lancet Respir Med. 2015 Nov;3(11):859-68. doi: 10.1016/S2213-2600(15)00326-4. Epub 2015 Oct 22.
- Results publication: PubMed 26168322Claessens YE, Debray MP, Tubach F, Brun AL, Rammaert B, Hausfater P, Naccache JM, Ray P, Choquet C, Carette MF, Mayaud C, Leport C, Duval X. Early Chest Computed Tomography Scan to Assist Diagnosis and Guide Treatment Decision for Suspected Community-acquired Pneumonia. Am J Respir Crit Care Med. 2015 Oct 15;192(8):974-82. doi: 10.1164/rccm.201501-0017OC.
- Individual participant dataSharing planned: No
Related trials for Ventilator-Associated Pneumonia
Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
Not yet recruitingObservational study
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
RecruitingPhase 4
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Blood Stream Infections, Ventilator Associated Pneumonia
Not yet recruiting
Mobile-Based Microlearning for Improving ICU Nurses' Adherence to Ventilator-Associated Pneumonia Prevention Protocols
Ventilator-Associated Pneumonia
Not yet recruitingPhase 3
Cefepime-Zidebactam Versus Ceftazidime-Avibactam With or Without Colistin for Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia
Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Associated Bacterial Pneumonia (VABP)
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.
Lila Bouadma, MD,PhD study director
Hôpital universitaire Bichat- Claude Bernard
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator-Associated Pneumonia and Tracheobronchitis, run by Centre Hospitalier Universitaire de Besancon at 2 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 3 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: status not confirmed, as of the sponsor's last update on 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul-Henri WICKY, MD (003680129209, phwicky@outlook.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance of diagnostic of tracheo-bronchitis or pneumonia under mechanical ventilation, between physician in charge and independent observator cunducting ultrasound and CT scan evaluation. (time frame: 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03018431, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2017.