Ventilator-associated pneumonia is the leading nosocomial infection in the intensive care units, and is associated with prolonged mechanical ventilation and overuse of antibiotics. Initiating antibiotic therapy immediately after bacteriological sampling (immediate strategy) may expose uninfected patients to unnecessary treatment, while waiting for bacteriological confirmation (conservative strategy) may delay ventilator-associated pneumonia in infected patients.
The decision to start antibiotic therapy for ventilator-associated pneumonia takes three points into account: diagnostic probability, the risks to the patient if Antibiotic Therapy is delayed, and the risk of selection of resistant bacteria. Diagnostic probability is limited, given the subjective and non-specific nature of the diagnostic criteria, and only 30-50% of suspected cases are confirmed bacteriologically (whereas samples are only taken when the pre-test probability is sufficient). The risks associated with delayed antibiotic therapy are unknown, as few observational studies have directly assessed the impact of the timing of Antibiotic Therapy initiation on outcome (frequent confusion between delayed and inappropriate Antibiotic Therapy).
Iregui et al. found that delaying Antibiotic Therapy by more than 24 hours was associated with higher mortality. However, more recent before-and-after studies have shown that the conservative strategy was associated with lower mortality, more frequently appropriate initial Antibiotic Therapy and shorter duration of Antibiotic Therapy. Similarly, in a recent before-and-after study by our team, initiating antibiotic therapy only upon microbiological confirmation of ventilator-associated pneumonia without septic shock or severe acute respiratory distress syndrome was not associated with an increase in ventilation time, length of stay or excess mortality at D28; but was associated with antibiotic therapy that was more often appropriate (DELAVAP, MARTIN et al, Annals of Intensive Care, 2024). Finally, the recent multicenter TARPP pilot study in surgical intensive care suggests that antibiotic therapy initiated on the basis of microbiological data in patients with suspected ventilator-associated pneumonia not requiring vasopressor support is not associated with a poorer outcome than immediate antibiotic therapy without documentation (the only randomized study on this subject).
Antibiotic Therapy for suspected ventilator-associated pneumonia that is not subsequently confirmed is an unnecessary use of antibiotics and carries a risk of selection of resistant bacteria, with adverse effects on public health. It has been reported that a conservative Antibiotic Therapy prescription strategy for intensive care units -acquired infections reduces Antibiotic Therapy use and the incidence of acquired β-lactamase-producing Enterobacteriaceae infections.
Overall, in patients with suspected ventilator-associated pneumonia but no signs of clinical severity, given the uncertainty about attributable mortality and concerns about bacterial resistance, the evaluation of the conservative Antibiotic Therapy strategy is reasonable. Some French intensive care units already delay Antibiotic Therapy until confirmation of ventilator-associated pneumonia, except in patients with severe hypoxemia or the need for vasopressor support.

开始日期2025-09-01

申办/合作机构

Nantes University Hospital

NCT06780722

/ Not yet recruitingN/AIIT

Study of the Occurrence of Cardiocirculatory Arrest As a Function of the Level of Hypoxemia During a Maastricht 3 Procedure. Prospective Observational Multicenter Study

Evaluation of the level of hypoxemia during the occurrence of cardiocirculatory arrest during a Maastricht III organ donation procedure.

开始日期2025-06-01

申办/合作机构

Nantes University Hospital

NCT06741189

/ Not yet recruitingN/AIIT

Cardiopediatric Home Monitoring Tool

We hypothesize that a home monitoring program combined with routine postoperative care significantly reduces morbidity and mortality after neonatal and pediatric cardiac surgery. This project differs from the previously published experiences by (a) providing an innovative telemedicine solution via the use of validated measurement sensors, (b) an alert system based on individualized standards, established for each care pathway, and (c) a protocolized response from medical teams in the management of alerts generated by the home monitoring tool.

开始日期2025-04-01

申办/合作机构

Nantes University Hospital

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2025-12-01·European Journal of Trauma and Emergency Surgery

Diagnostic performance of prehospital EFAST in predicting CT scan injuries in severe trauma patients: a multicenter cohort study

Article

作者: Balen, Frederic ; Tikvesa, Dino ; Le Conte, Philippe ; Grandpierre, Romain Genre ; Le Dortz, Marianne ; Markarian, Thibaut ; Bobbia, Xavier ; Vogler, Camille

BACKGROUNDThe early mortality of trauma patients, mainly from hemorrhagic shock, raises interest in detecting the presence of non-exteriorized bleeding. Intra-hospital EFAST (Extended Focused Assessment with Sonography for Trauma) has demonstrated its utility in the assessment and management of severe trauma patients (STP). However, there is a lack of data regarding the diagnostic performance of prehospital EFAST (pEFAST). The main objective of our study was to evaluate the pEFAST performance to predict a positive CT scan in STP.METHODSThis was a retrospective, multicenter, database-driven study. All severe trauma patients managed by a prehospital medical team were included. The results of pEFAST were compared with the admission CT scan.RESULTSData from 495 patients were included. The pEFAST had sensitivity of 27% (95% CI 22; 32) and specificity of 94% (95% CI 90; 97) for predicting the presence of a lesion on CT scan at hospital admission. The area under the curve (AUC) was 0.66 (95% CI 0.57; 0.63), the positive predictive value 84% (95% CI 75; 87), the negative predictive value was 51% (95% CI 44; 66), the positive likelihood ratio was 4.24 (95% CI 2.46; 7.3) and the negative likelihood ratio 0.78 (95% CI 0.72; 0.85).CONCLUSIONPrehospital EFAST has an excellent specificity but a poor sensitivity for predicting a positive CT scan on hospital admission. We do not know whether this low sensitivity is secondary to the delay between the two examinations or to the poor performance of pEFAST. Therefore, a negative pEFAST should not be reassuring. A positive pEFAST is highly informative, as it predicts a lesion and enables hospital management to be prepared accordingly.

2025-04-01·Annals of Physical and Rehabilitation Medicine

Complications of intrathecal baclofen therapy for spasticity: A single-centre cohort of 170 individuals

Article

作者: Buffenoir, Kévin ; Perrouin-Verbe, Brigitte ; Hirardot, Thomas ; Gross, Raphaël ; Gahier, Matthieu

BACKGROUNDIntrathecal baclofen (ITB) therapy effectively reduces severe spasticity but is associated with complications that can be serious. The evolution of these complications over time and their predictive factors are not well known.OBJECTIVESThe primary aim was to describe the incidence of ITB complications in adults with neurological disorders and disabling spasticity. The secondary aims were to describe the complications and the time-course of their incidence, to identify factors associated with complications, and to evaluate ITB effectiveness.METHODWe conducted a retrospective, single-centre, longitudinal observational study of data from people implanted with an ITB pump between 1995 and 2023. We calculated the incidence of complications overall and per category, and their evolution over the study period. Factors associated with complications were searched among demographic, clinical, device-related, and ITB dose characteristics. Effectiveness of ITB therapy was assessed using a goal-achievement scale.RESULTSData from 170 individuals were included (1577 years of ITB therapy); 198 complications were reported. Complication incidence was 0.13 events per pump-year and rate was 0.63 events per implantation. 49 % of complications were device related, 31 % procedure related and 20 % drug related. Surgical intervention was required for 63 % of complications. The main risk factors were walking capacity with odds ratio (OR) 3.12 (95 % CI 1.14 to 9.10, P = 0.030), and pre-Ascenda catheters with OR 3.36 (95 % CI 1.28 to 9.10, P = 0.014). Synchromed II pumps were associated with a higher risk of procedure-related complications: OR 3.41 (95 % CI 1.14 to 12.12, P = 0.039). Complication incidence decreased continuously during the study period, mainly because of a reduction in the number of device-related complications. Goals were partially achieved in 51 % of participants and achieved in 37 %.CONCLUSIONSThe incidence of complications associated with ITB therapy was high, and complications were mostly serious (requiring hospitalisation and/or life threatening). We recommend thorough examination of the benefits and risks of ITB therapy for each individual and systematic screening for dysfunctions at follow-up visits.

2025-03-01·Annals of Physical and Rehabilitation Medicine

Intensive interdisciplinary specialized rehabilitation or regular physiotherapy for multiple sclerosis? A randomised controlled trial with economic evaluation

Article

作者: Médée, B ; Jacota, M ; Gallien, P ; Aymard, C ; Zory, R ; Bonnyaud, C ; Sznajder, M ; Chenet, A ; Bensmail, D ; Hameau, S ; Heinzlef, O

BACKGROUNDThe benefits of Interdisciplinary Rehabilitation in an Outpatient Specialised Unit (IROSU) have not been determined.OBJECTIVESTo compare the effects of IROSU and physiotherapy in the community on impairment, function and Quality Of Life (QoL) in people with Multiple Sclerosis (pwMS) and to determine the medico-economic impact.METHODSPragmatic, multicentre, parallel, randomized (centralised computer-generated randomisation) controlled trial. 148 pwMS were analysed (73 in the IROSU group, 75 in the community group). IROSU included balance, stretching, walking, resistance and endurance training. The 6-Minute Walk Test (6MWT) was the primary outcome. Secondary outcomes were speed over 10 m, Timed Up and Go and Stair test, balance (Berg Balance Scale, posturology), knee extensor and flexor strength (isokinetic dynamometer), peak power output (cycling test), fatigue (Fatigue Severity Scale, Modified Fatigue Impact Scale), QoL (EuroQol EQ5D3 L, SEP59), anxiety and depression (Hospital Anxiety and Depression scale) and Multiple Sclerosis Impact Scale. Evaluations were performed before, after 4 weeks of training and 3 and 6 months after the start by therapists blinded to group allocation. Linear mixed effect models were used (intention-to-treat analysis). Cost-effectiveness and cost-utility ratios were analysed.RESULTS6MWT increased similarly in both groups from baseline to M1 (423.8 (126.7) m to 476.0 (119) m IROSU, 404.4 (99.3) m to 440.5 (112.1) m community, P < 0.001), to M3 (P < 0.001) and to M6 (P = 0.001). Knee extensor strength, power output and QoL-physical health improved significantly more in IROSU group (P < 0.05, effect size 0.25-0.61). Many improvements were maintained at the 6-month follow-up. Gain in quality adjusted life years and cost-utility ratios were in favour of IROSU.CONCLUSIONSWalking distance improved similarly in both groups but this was underpowered. The larger improvements in secondary outcomes and quality-adjusted life years after IROSU, maintained at the 6-month follow-up, suggest pwMS should have access to this program each year.TRIAL REGISTRATION CLINICAL TRIALSNCT01871818.

项与 Nantes University Hospital 相关的新闻（医药）

2024-11-22

·PipelineReview

First Patient Treated in Phase I/II Trial in Acute Myeloid and Acute Lymphoblastic Leukemia with Lu177-PentixaTher, Expanding the Evidence Base for Targeted Radiotherapy Approach

BERLIN and WURZBURG, Germany I November 21, 2024 I Pentixapharm Holding AG, a biopharmaceutical company developing innovative first-in-class radiopharmaceuticals, today announced that the first patient has been treated in a Phase I/II clinical trial evaluating the safety and efficacy of Lu177-PentixaTher, a novel radiopharmaceutical therapy, in adults for relapsed/refractory CXCR4 positive acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). The trial, funded by the French Ministry of Health and led by a renowned investigator team from the University Hospital in Nantes, represents a significant step toward expanding targeted radiotherapy options for hematologic malignancies. The investor-initiated study, named PENTILULA (ClinicalTrials.gov ID: NCT06356922) is a multicenter, open-label trial in which up to 21 patients with relapsed/refractory AML or ALL will be enrolled over a period of 24 months, with a total study duration of 36 months. The primary objective is to determine the maximal tolerated dose (MTD) of Lu177-PentixaTher, and to examine key efficacy parameters such as overall response rate (ORR) and complete remission (CR) after infusion of the novel radiotherapeutic agent. Following a peer-reviewed publication in January 2023 in the prestigious Journal of Nuclear Medicine highlighting promising clinical results in the treatment of patients suffering from T-cell lymphoma, further evidence continues to be built up about the potential of Pentixapharm’s lead candidate, PentixaTher, for the treatment of haemato-oncological diseases. The study is significant for Pentixapharm insofar as the incidence of ALL and AML, and hence the medical need, is much higher than that for T-Cell lymphoma. The PENTILULA trial is the first trial that combines PentixaTher with Lutetium-177, a radioisotope widely and successfully used for the treatment of castration resistant prostate cancer or neuroendocrine tumors. Acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) are aggressive and life-threatening blood cancers that affect thousands of people worldwide each year. AML is the most common type of acute leukemia in adults, with an incidence of approximately 20,000 new cases per year and low five-year survival rate of 31.9% in the United States [1]. ALL is the most common type of cancer in children, with a high incidence in adults as well. Current treatment options often involve intensive chemotherapy and stem cell transplantation, which can have severe side effects. Effective radiotherapies in other indications are currently reimbursed with more than 100,000 USD per patient. “Although treatments for acute leukemia have advanced, many patients continue to have limited options and face poor outcomes. We believe PentixaTher holds significant potential to address these unmet needs, offering a valuable radiopharmaceutical theranostic approach tailored to the individual patients with hematologic malignancies,” explains Dr. Dirk Pleimes, Group CEO and CMO at Pentixapharm. “We are delighted that leading experts such as Professor Françoise Kraeber-Bodéré of the Nuclear Medicine Department and Professor Patrice Chevallier of the Hematology Department in Nantes have decided to initiate this study to evaluate this novel radiotherapeutic treatment option. We are committed to providing our full support, leveraging our therapeutic knowledge with PentixaTher and facilitating access to the compound to drive this important research forward.” Professor Françoise Kraeber-Bodéré is the Head of the department of Nuclear Medicine at the University Hospital in Nantes, France, and an expert of the Oncology committee of the French Society of Nuclear Medicine (SFMN) as well as of the Oncology and Therapy committee of the European Association of Nuclear Medicine. She is on the scientific board of the French Lymphoma research group LYSA and expert for PET imaging in lymphoma and myeloma. Professor Patrice Chevallier is a specialist in Hematology and member of the executive committee and scientific council of HéMA, an umbrella organization for hemato-oncological research in Western France. About Pentixapharm Pentixapharm is a clinical-stage biotech company discovering and developing novel targeted radiopharmaceuticals with its offices in Berlin and Würzburg, Germany. It is committed to developing CXCR4 ligand-based first-in-class radiopharmaceutical approaches with a clear commercial pathway for diagnostic and therapeutic programs in a number of hematological and solid cancers, as well as cardiovascular, endocrine and inflammatory diseases. Its Pipeline includes PentixaTher, an Yttrium-90 or Lutetium-177 based therapeutic against non-Hodgkin lymphomas (NHL), and PentixaFor, a Gallium-68 based companion diagnostic for blood cancers and cardiovascular diseases. PentixaTher is an innovative radiotherapeutic that specifically targets the chemokine-4 receptor (CXCR4). Background material about its potential for the treatment of haematooncological diseases can be found at: About Nantes University Hospital Nantes University Hospital (CHU de Nantes) is one of France’s leading healthcare institutions, recognized for its excellence in various medical specialties including cardiology, transplants, oncology, and neuroscience. The hospital is also a key player in medical research and innovation, conducting thousands of clinical trials and contributing to significant advancements in healthcare. [1] https://seer.cancer.gov/statfacts/html/amyl.html SOURCE: Pentixapharm

临床研究

2024-11-21

·GlobeNewswire-Health Care

First Patient Treated in Phase I/II Trial in Acute Myeloid and Acute Lymphoblastic Leukemia with Lu177-PentixaTher, Expanding the Evidence Base for Targeted Radiotherapy Approach

BERLIN and WURZBURG, Germany, Nov. 21, 2024 (GLOBE NEWSWIRE) -- Pentixapharm Holding AG, a biopharmaceutical company developing innovative first-in-class radiopharmaceuticals, today announced that the first patient has been treated in a Phase I/II clinical trial evaluating the safety and efficacy of Lu177-PentixaTher, a novel radiopharmaceutical therapy, in adults for relapsed/refractory CXCR4 positive acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). The trial, funded by the French Ministry of Health and led by a renowned investigator team from the University Hospital in Nantes, represents a significant step toward expanding targeted radiotherapy options for hematologic malignancies. The investor-initiated study, named PENTILULA (ClinicalTrials.gov ID: NCT06356922) is a multicenter, open-label trial in which up to 21 patients with relapsed/refractory AML or ALL will be enrolled over a period of 24 months, with a total study duration of 36 months. The primary objective is to determine the maximal tolerated dose (MTD) of Lu177-PentixaTher, and to examine key efficacy parameters such as overall response rate (ORR) and complete remission (CR) after infusion of the novel radiotherapeutic agent. Following a peer-reviewed publication in January 2023 in the prestigious Journal of Nuclear Medicine highlighting promising clinical results in the treatment of patients suffering from T-cell lymphoma, further evidence continues to be built up about the potential of Pentixapharm’s lead candidate, PentixaTher, for the treatment of haemato-oncological diseases. The study is significant for Pentixapharm insofar as the incidence of ALL and AML, and hence the medical need, is much higher than that for T-Cell lymphoma. The PENTILULA trial is the first trial that combines PentixaTher with Lutetium-177, a radioisotope widely and successfully used for the treatment of castration resistant prostate cancer or neuroendocrine tumors. Acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) are aggressive and life-threatening blood cancers that affect thousands of people worldwide each year. AML is the most common type of acute leukemia in adults, with an incidence of approximately 20,000 new cases per year and low five-year survival rate of 31.9% in the United States [1]. ALL is the most common type of cancer in children, with a high incidence in adults as well. Current treatment options often involve intensive chemotherapy and stem cell transplantation, which can have severe side effects. Effective radiotherapies in other indications are currently reimbursed with more than 100,000 USD per patient. “Although treatments for acute leukemia have advanced, many patients continue to have limited options and face poor outcomes. We believe PentixaTher holds significant potential to address these unmet needs, offering a valuable radiopharmaceutical theranostic approach tailored to the individual patients with hematologic malignancies,” explains Dr. Dirk Pleimes, Group CEO and CMO at Pentixapharm. “We are delighted that leading experts such as Professor Françoise Kraeber-Bodéré of the Nuclear Medicine Department and Professor Patrice Chevallier of the Hematology Department in Nantes have decided to initiate this study to evaluate this novel radiotherapeutic treatment option. We are committed to providing our full support, leveraging our therapeutic knowledge with PentixaTher and facilitating access to the compound to drive this important research forward.” Professor Françoise Kraeber-Bodéré is the Head of the department of Nuclear Medicine at the University Hospital in Nantes, France, and an expert of the Oncology committee of the French Society of Nuclear Medicine (SFMN) as well as of the Oncology and Therapy committee of the European Association of Nuclear Medicine. She is on the scientific board of the French Lymphoma research group LYSA and expert for PET imaging in lymphoma and myeloma. Professor Patrice Chevallier is a specialist in Hematology and member of the executive committee and scientific council of HéMA, an umbrella organization for hemato-oncological research in Western France. About Pentixapharm Pentixapharm is a clinical-stage biotech company discovering and developing novel targeted radiopharmaceuticals with its offices in Berlin and Würzburg, Germany. It is committed to developing CXCR4 ligand-based first-in-class radiopharmaceutical approaches with a clear commercial pathway for diagnostic and therapeutic programs in a number of hematological and solid cancers, as well as cardiovascular, endocrine and inflammatory diseases. Its Pipeline includes PentixaTher, an Yttrium-90 or Lutetium-177 based therapeutic against non-Hodgkin lymphomas (NHL), and PentixaFor, a Gallium-68 based companion diagnostic for blood cancers and cardiovascular diseases. PentixaTher is an innovative radiotherapeutic that specifically targets the chemokine-4 receptor (CXCR4). Background material about its potential for the treatment of haematooncological diseases can be found at: https://edoc.mdc-berlin.de/id/eprint/24012/1/24012oa.pdf About Nantes University Hospital Nantes University Hospital (CHU de Nantes) is one of France's leading healthcare institutions, recognized for its excellence in various medical specialties including cardiology, transplants, oncology, and neuroscience. The hospital is also a key player in medical research and innovation, conducting thousands of clinical trials and contributing to significant advancements in healthcare. For more information, please contact: Pentixapharm Holding AGPhillip Eckert, Investor Relationsir@pentixapharm.comTel. +49 30 94893232www.pentixapharm.com [1] https://seer.cancer.gov/statfacts/html/amyl.html

临床研究

2024-11-05

·PipelineReview

OSE Immunotherapeutics Announces Statistically Significant and Clinically Meaningful Results from the Phase 2 Study of Anti-IL7R mAb Lusvertikimab for the Treatment of Ulcerative Colitis

NANTES, France I November 4, 2024 I OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), today reported positive results from the induction period of the CoTikiS randomized, double-blind, placebo-controlled, Phase 2 study of Lusvertikimab (OSE-127) demonstrating a strong efficacy and favorable safety profile in moderate to severe active ulcerative colitis (UC). Topline results from the CoTikiS Phase 2 Study The randomized, double-blind Phase 2 clinical trial CoTikiS has evaluated the efficacy and the safety of Lusvertikimab versus placebo in 136 patients with moderate to severe active UC who failed or lost response to previous treatment(s)*. CoTikiS is a 50-week study, with a 10-week induction period evaluating two doses (450mg or 850mg) of Lusvertikimab against placebo, a 24-week additional open label treatment extension period (OLE) during which all subjects received Lusvertikimab 850mg infusions every 4 weeks and a 16-week safety follow-up period free of treatment. Lusvertikimab (Lusv) met the primary efficacy endpoint defined by the improvement of the Modified Mayo Score (MMS)** at week 10 (W10) at the two doses tested and demonstrated statistically significant and clinically meaningful results on key secondary endpoints. A favorable safety profile was observed during both the induction period and during the 6 months of open-label extension period trial. 134 patients were analyzed in the W0-W10 period [group 850mg (50 patients); group 450mg (35 patients); drug group pooled 850mg + 450mg (85 patients); group placebo (49 patients)]. A total of 120 patients treated with Lusvertikimab participated to the additional 24-week OLE treatment period. Final analysis of the primary endpoint at W10*** Improvement of the global Disease Activity Index of UC (MMS) Key secondary endpoint results at W10 Clinical remission**** Endoscopic remission (endoscopic score at 0) Endoscopic improvement (endoscopic score ≤ 1 point) Ulcerative Colitis Endoscopic index of Severity***** (UCEIS score decreases at week 10) Safety Profile Lusvertikimab displayed a good safety profile and was well tolerated, with no difference between both dose groups and placebo in the incidence of drug related serious adverse events (SAEs), adverse events (AEs) leading to discontinuation, severe drug-related AEs, opportunistic infections or infusion reactions during the induction period. In addition, no safety signal was observed in the patient population who received 850mg of Lusvertikimab for an additional 24-week period in the OLE, regardless of the initial randomization groups. Pr. Arnaud Bourreille, Associate professor in Gastroenterology, Institut des Maladies de l’Appareil Digestif, Nantes University Hospital, Principal/ Scientific coordination of the CoTikiS study , said: “We are very excited to share these positive topline efficacy results which could establish Lusvertikimab as a potential new breakthrough therapeutic option for UC patients. We are beyond enthusiastic with the very high endoscopy efficacy and what it could mean for patients suffering from chronic ulcerative colitis. This promising drug-candidate with a differentiated mode of action and very good safety profile needs to be further actively explored in ulcerative colitis and in other indications. We are grateful to all the investigators and patients for their participation in this study and we are eager to present a more complete clinical and biomarkers data set in future medical congresses.” Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics , adds: “These impressive efficacy and safety results represent a major milestone in the clinical development of Lusvertikimab and a strong catalyst for the subsequent steps. Lusvertikimab has clearly demonstrated meaningful clinical proof-of-efficacy in UC and we are now looking forward to further evaluating it in additional studies with the ultimate goal of making this innovative therapy accessible to millions of patients in need of more efficacious and safe treatments. Lusvertikimab is a pure interleukin-7 receptor antagonist mAb and we believe it has a broad first-in-class potential in various chronic inflammatory and autoimmune diseases. We look forward to making progress on this strategy and to go ahead with the most relevant partners.” * Previous corticosteroids, immunosuppressive agents or previous biological treatments. ** Ulcerative Colitis is a chronic inflammatory disease of the rectum and colon characterized by mucosal inflammation, abdominal pain associated with symptoms and frequency of diarrhea and rectal bleeding. The moderate to severe UC is measured by a Modified Mayo Score (MMS) between 4 and 9, inclusive. The primary endpoint is the mean change at Week 10 from baseline in the Modified Mayo Score, a Disease Activity Index for UC defined by the addition of the stool frequency and the rectal bleeding sub-scores (two patient’s clinical elements as Patient Reported Outcomes) and the endoscopic sub-score (mucosal endoscopy activity), assessed by an endoscopist through a central reading platform. *** An interim Futility analysis performed early (about 30% of patients) by the IDMC proposed interruption of the 450 mg group for risk of futility. The 850 mg group was initially considered as primary analysis, in the final analysis the futility of the 450mg was not confirmed. SAP (Statistical Analysis Plan) Addendum: Results of 450mg group reconsidered with all patients already included in this group. In addition, the two groups have been pooled for the drugs cohort to a global treatment effect. **** Clinical remission at Week 10, a modified Mayo score of ≤ 2 points with no individual sub-score of > 1 point and a rectal bleeding at 0, therefore a stool frequency score of 0 or 1 and an endoscopic score of 0 or 1. ***** Ulcerative Colitis Endoscopic Index of Severity, UCEIS, is a validated endoscopic scoring tool with lower interobserver variability, score change at Week 10 from baseline measuring specific subscores: vascular pattern/ presence of bleeding/ erosions and ulcerations (Pabla B S et al Gastroenterol Clin North Am. 2020). About OSE Immunotherapeutics OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology (IO) and immuno-inflammation (I&I). The Company’s current well-balanced first-in-class clinical pipeline includes: OSE Immunotherapeutics expects to generate further significant value from its three proprietary drug discovery platforms, which are central to its ambitious goal to deliver next-generation first-in-class immunotherapies: Additional information about OSE Immunotherapeutics assets is available on the Company’s website: www.ose-immuno.com . Follow us on X and LinkedIn SOURCE: OSE Immunotherapeutics

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