Aim: To evaluate the 24-week interim outcomes of bedaquiline-containing regimens in the treatment of adolescents with rifampicin-resistant tuberculosis (RR-TB) in China.
Methods: Adolescents with RR-TB from two hospitals were included in this retrospective study. All patients received the longer regimen containing bedaquiline. Sputum culture, chest computed tomography, blood tests and electrocardiography were performed regularly, and the outcomes after 24 weeks of treatment were reported.
Results: Four male and six female adolescents aged 11 to 17 years old were included. Among them, four (40.0%), four (40.0%) and two (20.0%) were confirmed to have RR-TB, multidrug-resistant TB and extensively drug-resistant TB, respectively. The most common companion drugs included linezolid (100.0%), cycloserine (90.0%), pyrazinamide (80.0%), moxifloxacin (50.0%) and levofloxacin (40.0%). Culture conversion rates of 80.0%, 100.0% and 100.0% were observed at weeks 2, 4 and 24, respectively. The mean maximum drug concentration of bedaquiline at weeks 2, 12 and 24 was 3.29 ± 0.66, 1.78 ± 0.81 and 1.93 ± 0.74 μg/mL, respectively. Six adverse events including leukopenia (50.0%), Fridericia-corrected QT (QTcF) interval prolongation (16.7%), anaemia (16.7%) and peripheral neuropathy (16.7%) were observed in five (50.0%) patients. No patient discontinued bedaquiline owing to QTcF interval prolongation. Meanwhile, no deaths, reversions or serious adverse events were reported during 24 weeks of treatment.
Conclusion: A longer regimen containing bedaquiline was effective and well tolerated in Chinese adolescents with RR-TB. The combination of bedaquiline and linezolid may be a favourable choice for this population.
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http://dx.doi.org/10.1111/jpc.15672 | DOI Listing |
Background: CT1812 is an experimental therapeutic sigma-2 receptor modulator in development for Alzheimer's disease (AD) and dementia with Lewy bodies. CT1812 reduces the affinity of Aβ oligomers to bind to neurons and exert synaptotoxic effects. This phase 2, multi-center, international, randomized, double-blind, placebo-controlled trial assessed safety, tolerability and effects of CT1812 on cognitive function in individuals with AD.
View Article and Find Full Text PDFAlzheimers Dement
December 2024
Centre for Ageing Research and Translation, University of Canberra, Bruce, ACT, Australia.
Background: The Sustainable Personalised Interventions for Cognition, Care, and Engagement (SPICE) program was developed to address an identified gap in access to high-quality integrated post-diagnostic rehabilitation for people with dementia and their care partners in Canberra, Australia. The multicomponent intervention aims to maximise quality of life (QoL) and independence of people with dementia by increasing engagement in everyday and meaningful activities and promoting care partners' physical and mental well-being.
Method: The SPICE program is a waiting-list study design delivered by a multidisciplinary allied health team over twelve weeks.
Int J Clin Pediatr Dent
November 2024
Department of Pharmacology, Saveetha Dental College and Hospitals, Saveetha Institute of Medical and Technical Sciences, Saveetha University, Chennai, Tamil Nadu, India.
Aim And Background: Glass ionomer cement (GIC) serves as a widely used restorative dental material, known for its direct bonding to tooth structures and fluoride-releasing properties. This study aims to investigate the enhancement of GIC through the incorporation of a green-mediated nanocomposite comprising chitosan, titanium, zirconium, and hydroxyapatite, with a focus on evaluating the wear resistance of the modified GIC.
Materials And Methods: A one-pot synthesis technique was utilized to prepare a green-mediated nanocomposite incorporating chitosan, titanium, zirconium, and hydroxyapatite nanoparticles.
Eur J Haematol
January 2025
Hematology and Transplant Center, University Hospital "San Giovanni di Dio e Ruggi d'Aragona", Salerno, Italy.
Brentuximab-vedotin (BV)-induced neurotoxicity (BVIN), a frequent adverse event caused by this monoclonal antibody, is the primary reason for dose modification or drug discontinuation, and is characterized by sensory, motor, and/or autonomic peripheral nerve dysfunctions. Although reversible, BVIN can persist for months or years after treatment and negatively affect quality of life (QoL). Currently, BVIN is managed by dose adjustment or drug interruption, leading to an increased risk of disease relapse.
View Article and Find Full Text PDFTher Innov Regul Sci
January 2025
Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, 19104, USA.
It has long been a basic principle of randomized clinical trials addressing serious outcomes and/or major public health issues that interim data should be inaccessible to investigators and to industry sponsors, with interim data reviewed on a regular basis by an independent data monitoring committee (DMC). Challenges to this principle may arise when sponsors and/or regulators perceive a need to review interim data while the trial remains ongoing-for example, when a trial is being considered for accelerated approval. In this paper we propose approaches that could minimize the extent of interim data that is made available to others while the trial continues.
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