Clinical trials: De-escalation
Infection
DetermInants of Antimicrobial Use aNd De-escalAtion in Critical Care (DIANA)
DetermInants of Antimicrobial use aNd de-escalAtion in critical care (DIANA study), is a multicenter, international, prospective, observational cohort study, aiming to describe the rate of de-escalation as well as the associated…
- Trial name
- DIANA (NCT02920463)
- Where
- Belgium
- Volunteers
- 1,495 people
- Sponsor
- University Hospital, Ghent
Opioid Dependence
DE-eSCALation of Opioids Post-surgical dischargE
The Descale Study aims to: 1. Look at the prescribing trends of opioids and the scale of long-term use following surgery within East Kent (United Kingdom) 2.
- Trial name
- DESCALE (NCT06396663)
- Testing
- Rapid Opioid de-escalation, Gradual Opioid de-escalation, Continuation of opioids
- Where
- United Kingdom
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Kent
Ischemic Stroke, Transient Ischemic Attack
Ticagrelor Based De-Escalation of Dual Antiplatelet Therapy in Ischemic Stroke
This is a randomized, controlled, outcome assessor blind, parallel group design pilot study on 100 patient with diagnosis of ischemic stroke admitted in Bou-Ali Sina Hospital, Sari,Iran.The aim of study is to compare the efficacy…
- Trial name
- DEDAPT-TICA (NCT06653348)
- Testing
- Ticagrelor 60 + Aspirin, Ticagrelor 90 + aspirin
- Where
- Iran
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Mazandaran University of Medical Sciences
Triple Negative Breast Cancer (TNBC), Elevated Tumor-Infiltrating Lymphocytes
A Phase II Study of Biomarker-Guided De-escalation Using Anthracycline-Free Neoadjuvant Chemoimmunotherapy in Early-Stage Triple Negative Breast Cancer (TNBC) Patients With High Tumor-Infiltrating Lymphocytes (TILs)
This study tests a new treatment approach for people with early-stage triple negative breast cancer whose tumors have a high number of immune cells, called tumor-infiltrating lymphocytes or TILs, as seen by a pathologist on…
- Trial name
- NeoTILs (NCT07743190)
- Testing
- Carboplatin, Paclitaxcel, Pembrolizumab
- Where
- 2 sites in United States
- Volunteers
- 55 people
- Sponsor
- Medical University of South Carolina
Safety, Immunogenicity
EMaBS TB Vaccine Study
The study will commence with a dose-escalation and age de-escalation study in healthy adults and adolescents from the previous Entebbe Mother and Baby Study (EMaBS) in Entebbe, Uganda, focusing on ChAdOx1 85A, to provide safety…
- Trial name
- NCT03681860
- Testing
- ChAdOx185A, MVA85A, BCG
- Where
- 2 sites in Uganda, United Kingdom
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Indolent Lymphoma
Dose De-escalation Study of the PI3k Alpha/Delta Inhibitor, Copanlisib Given in Combination With the Immunotherapeutic Agents, Nivolumab and Rituximab in Patients With Relapsed/Refractory Indolent Lymphoma
Patients with relapsed or refractory follicular or marginal zone lymphoma who have received at least one prior line of therapy will receive Copanlisib IV: day 1, 8, 15 every 28 days Nivolumab IV: Cycle 1 days 1 and 15; then day 1…
- Trial name
- NCT04431635
- Testing
- Copanlisib, Nivolumab, Rituximab
- Where
- 5 sites in United States
- Volunteers
- 6 people
- Sponsor
- University of Michigan Rogel Cancer Center
Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Optimal PSA Triggered Individual Management of Androgen Sensitive Prostate Cancer
The purpose of this study is to evaluate intermittent relugolix + androgen receptor pathway inhibitor (ARPI) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) achieving optimal PSA response.
- Trial name
- OPTIMAS (NCT07216248)
- Testing
- relugolix + ARPI, Intermittent- Relugolix or androgen deprivation therapy (ADT) + ARPI, relugolix or androgen deprivation therapy (ADT) + ARPI
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- University of Utah
Relapsing-Remitting Multiple Sclerosis (RRMS), Anti-CD20 Therapy
A Prospective Randomized Non-inferiority Trial Comparing Anti-CD20 Maintenance Versus De-Escalation Strategy In Relapsing-Remitting Multiple Sclerosis
Multiple sclerosis (MS), the main central nervous system autoimmune disorder, is the first cause of non-traumatic disability in young adults and has thus significant individual consequences with elevated public health cost.
- Trial name
- DESIRE MS (NCT07189325)
- Testing
- Platform therapies (Dimethyl Fumarate, Teriflunomide, Glatiramer Acetate, Beta-interferons), Anti-CD20 therapies (Ocrelizumab, Rituximab, Ofatumumab)
- Where
- France
- Volunteers
- 250 people
- Sponsor
- University Hospital, Montpellier
HER2-positive Breast Cancer
Four Cycles Taxane With Trastuzumab and Pertuzumab Neoadjuvant Therapy Among Low Risk HER2 Positive Patients
Neoadjuvant therapy in the treatment of breast cancer is not only a means of breast conserving surgery, but also a sensitive scheme for patients, in order to reduce the treatment grade, low toxicity and high efficiency.
- Trial name
- LRNacHER2 (NCT06722599)
- Where
- China
- Volunteers
- 171 people
- Sponsor
- Shu Wang
Locally Advanced Nasopharyngeal Carcinoma
Serplulimab Combined With Induction Chemotherapy and Radiotherapy in Nasopharyngeal Carcinoma
This phase III trial aims to evaluate the efficacy and safety of induction chemotherapy combined with serplulimab (induction/maintenance therapy) with omission of concurrent chemotherapy in patients with locally advanced…
- Trial name
- NCT07177443
- Testing
- Radiotherapy, Serplulimab, Cisplatin
- Where
- China
- Volunteers
- 710 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Intermediate Risk Prostate Cancer (Diagnosis), Prostate Cancer
Dose-dEscalated MR-Guided Radiotherapy for Localized Prostate Cancer
DESTINATION 2 is a multi-centre randomised trial treating intermediate risk localised prostate cancer with 2 fraction Stereotactic Body Radiotherapy (SBRT).
- Trial name
- DESTINATION 2 (NCT07674225)
- Testing
- Prostate radical radiotherapy
- Where
- Canada
- Volunteers
- 24 people
- Sponsor
- Sunnybrook Health Sciences Centre
Diarrhoea
A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants
The aim of the current clinical study was to evaluate, for the first time in humans (FTIH), the safety and immunogenicity of the altSonflex1-2-3 candidate vaccine against S. sonnei and S. flexneri serotypes 1b, 2a, and 3a.
- Trial name
- NCT05073003
- Testing
- AltSonflex1-2-3 High Dose, AltSonflex1-2-3 Medium Dose, AltSonflex1-2-3 Low Dose
- Where
- 2 sites in Belgium, Kenya
- Volunteers
- 551 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Ulcerative Colitis (UC), Crohn's Disease
Efficacy and Safety of Discontinuing 5-ASA in Patients With Inflammatory Bowel Disease
This study aims to evaluate the long-term outcomes of discontinuing 5-ASA in UC and CD patients receiving stable biologic or immunomodulator therapy using a prospective cohort based in the Busan-Ulsan-Gyeongnam region.
- Conditions
- Ulcerative Colitis (UC), Crohn's Disease, Inflammatory Bowel Disease (IBD)
- Trial name
- NCT06878495
- Testing
- Discontinuation of 5-ASA
- Volunteers
- 100 people
- Sponsor
- Pusan National University Hospital
Safety Issues
Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever
This is a randomized study to evaluate the safety and feasibility of early de-escalation of empirical antibiotics treatment in neutropenic fever patients undergoing hematopoietic stem cell transplantation (HSCT).
- Trial name
- NCT04270786
- Testing
- Early de-escalation, Standard
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Shanghai Jiao Tong University School of Medicine
Community-acquired Pneumonia
Use of a Rapid Diagnostic Test for Antibiotic De-escalation in Severe Community Acquired Pneumonia
The purpose of this study is to conduct an open-label step-wedge pilot clinical trial to compare an antibiotic strategy based on routine use of a novel rapid diagnostic test to usual care in critically ill adults with severe…
- Trial name
- BioFire (NCT04781829)
- Testing
- BioFire Pneumonia Panel
- Sponsor
- Northwestern University
Malaria
Safety, Tolerability and Immunogenicity of PfSPZ Vaccine in an Age De-escalation Trial in Equatorial Guinea.
This trial will evaluate the safety, tolerability, and immunogenicity of PfSPZ Vaccine in healthy Equatoguinean adults, adolescents, children and infants who receive doses of 0.9x10^6, 1.8x10^6 or 2.7x10^6 PfSPZ Vaccine via…
- Trial name
- NCT02859350
- Testing
- PfSPZ Vaccine, PfSPZ Challenge (for CHMI), Normal Saline
- Where
- Equatorial Guinea
- Volunteers
- 135 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Malaria,Falciparum
A Study to Assess the Experimental Malaria Vaccines R78C and RH5.1 Combined With R21/Matrix-M (a "Multi-stage" Malaria Vaccine)
This is a Phase Ib age de-escalation, dose escalation, open-label study to assess the safety and immunogenicity of the multi-stage malaria vaccine candidate R21 plus RH5.1 and/or R78C in Matrix-M in adults aged 18-35 years and…
- Trial name
- VAC093 (NCT06958198)
- Testing
- R21, RH5.1, R78C
- Where
- Burkina Faso
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Dementia
Individualized Music Playlist Based on ISO Principle for De-escalation of Agitation in Dementia
The goal of this clinical trial is to evaluate the efficacy of an Individualized Music Playlist (InMP) composed of preferred music genres sequenced according to the ISO-Principle, for the immediate de-escalation of agitation in…
- Trial name
- NCT06104436
- Testing
- Individualized music playlist, Preferred music, Usual care
- Where
- Hong Kong
- Volunteers
- 81 people
- Sponsor
- The Hong Kong Polytechnic University
Prostate Cancer
PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Recurrent Prostate Cancer
Purpose: Prospective, single-site Phase II study testing whether PSMA-PET/MRI-guided, de-escalated salvage radiation reduces acute Grade ≥2 toxicity versus a 44% historical rate, while maintaining cancer control after…
- Trial name
- NCT07234981
- Testing
- PSMA-guided Salvage Radiation
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- University of Nebraska
Sepsis
Use of Procalcitonin, a Blood Test to Guide Antibiotic Therapy for Sepsis in Adults
Trial design: Randomised controlled, two-arm, parallel, clinical trial to assess the efficacy and safety of sequential daily procalcitonin assessments to guide de-escalation of empirical antibiotic therapy in adult patients with…
- Trial name
- PROCALBAN (NCT05955612)
- Testing
- Procalcitonin measurement
- Where
- Bangladesh
- Volunteers
- 532 people
- Sponsor
- University of Oxford