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Søgning på udtrykket 'phase 3' giver 25 resultater
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BMJ Open
3.04.2025
…ral nervous system penetration alongside adjuvant anti-inflammatory therapy are needed to improve outcomes. . Methods and analysis. The Shortened Intensive Therapy for Children with Tuberculous Meningitis (SURE) trial is a phase 3, randomised, partially blinded, factorial trial being conducted in Asia (India and Vietnam) and Africa (Uganda, Zambia and Zimbabwe). It is coordinated by the Medical Research Council Clinical Trial Unit at University College London (MRCCTU at UCL). 400 children (aged 29 days to
Lancet Microbe
1.04.2025
Among adolescents participating in the PREVENT-19 trial during the delta (B.1.617.2) variant wave of the COVID-19 pandemic, the NVX-CoV2373 vaccine was highly efficacious against SARS-CoV-2 infection regardless of symptoms, indicating its potential to reduce the reservoir of infections that contribute to community transmission.
Lancet
28.03.2025
When compared with a licensed, quadrivalent meningococcal conjugate vaccine, and given alongside other routine vaccines, a single dose of NmCV-5 was safe and elicited a non-inferior immune response in infants aged 9 months and young children aged 15 months.
Lancet Infectious Diseases
20.03.2025
Non-inferior immune responses for extended two-dose regimens of 2vHPV support dosing flexibility. For up to 24 months, one dose of 2vHPV elicited immunogenicity that was similar to one dose of 4vHPV, for which single-dose efficacy has been shown, supporting a single-dose use of 2vHPV.
Clinical Infectious Diseases
14.03.2025
Abstract . Background . Doravirine/islatravir is an investigational, once-daily regimen being studied for HIV-1 treatment.Methods . In this phase 3, double-blind, non-inferiority trial, previously untreated people with HIV-1 (≥18 years) were randomized (1:1) and stratified by HIV-1 RNA (≤/>100,000 copies/mL) and CD4 count (
BMJ Open
6.03.2025
. Objectives. To investigate the long-term safety and efficacy of otilimab, an antigranulocyte-macrophage colony-stimulating factor monoclonal antibody, for patients with rheumatoid arthritis (RA). . Methods. ContRAst X (NCT04333147) was a phase 3, multicentre, long-term extension trial. Patients with RA aged ≥18 years who completed a qualifying contRAst trial (contRAst 1–3) and who the investigator thought might benefit from long-term otilimab treatment were eligible to enter contRAst X.
Lancet Respiratory Medicine
5.03.2025
Dupilumab, as an add-on to standard triple therapy, reduced the annualised rate of moderate or severe exacerbations compared with placebo, highlighting its potential for personalised treatment approaches in patients with COPD with specific clinical endotypes.
Journal of Acquired Immune Deficiency Syndromes
28.02.2025
…ecommended for initial antiretroviral therapy (ART) in adults living with HIV-1; however, no clinical trials have assessed this regimen in adolescents, a potentially more challenging population to treat. We evaluated efficacy, safety, and pharmacokinetics of dolutegravir/lamivudine as initial ART in adolescents living with HIV-1. Setting: . Nine centers in Thailand, Kenya, and South Africa. Methods: . In the single-arm, open-label, phase 3b DANCE study (NCT03682848), adolescents naive to ART aged ≥12 to
Lancet Infectious Diseases
25.02.2025
The primary analysis showed efficacy and safety of sipavibart in preventing symptomatic COVID-19 in participants who are immunocompromised when susceptible (ie, non-Phe456Leu-containing) variants dominated, although no efficacy was shown against resistant (ie, Phe456Leu-containing) variants that dominate as of November, 2024.
Clinical Infectious Diseases
17.02.2025
Abstract . Background . Ensitrelvir, a severe acute respiratory syndrome coronavirus-2 main protease inhibitor, has demonstrated clinical and virologic efficacy in previous studies.Methods . In this global phase 3 trial, nonhospitalized adults with mild-to-moderate coronavirus disease 2019 (COVID-19) and symptom onset within 5 days were randomized (1:1) to receive once-daily ensitrelvir (375 mg day 1, 125 mg days 2–5) or blinded matching placebo.
Lancet Infectious Diseases
5.02.2025
Repeated high-dose ivermectin MDA integrated with SMC distributions at the study site did not reduce malaria incidence among children relative to placebo MDA, despite evidence that, compared with the control group, mosquito survivorship in the first year was reduced in the intervention group the week following MDA and overall improvements in haemoglobin were greater in children in the intervention group.
Clinical Infectious Diseases
30.01.2025
Abstract . Background . Cabotegravir + rilpivirine (CAB + RPV) administered via intramuscular gluteal injections is the first complete long-acting regimen for maintaining human immunodeficiency virus type 1 (HIV-1) virologic suppression. We present substudy results on short-term repeat intramuscular CAB + RPV long-acting thigh injections in participants with ≥3 years of experience with gluteal administration during the ATLAS–2M study.Methods .
Clinical Infectious Diseases
26.12.2024
Abstract . Background . A MenABCWY vaccine containing 4CMenB and MenACWY-CRM vaccine components has been developed to protect against the five meningococcal serogroups that cause most invasive disease cases.Methods . In this phase 3 study (NCT04707391), healthy participants aged 15–25 years, who had received MenACWY vaccination ≥4 years previously, were randomized (1:1) to receive two MenABCWY doses six months apart or one MenACWY-CRM dose.
Antimicrobial Agents And Chemotherapy
20.12.2024
Antimicrobial Agents and Chemotherapy, Ahead of Print.
Lancet Infectious Diseases
6.12.2024
This study demonstrates breadth of immune response against a panel of 110 MenB strains for the MenB component of the investigational MenABCWY vaccine, when administered as a 0–6 months schedule to the target population of adolescents and young adults, with predefined criteria for success met for both breadth of immune response endpoints and for non-inferiority versus 4CMenB.
Clinical Infectious Diseases
5.12.2024
… tract infection (LRTI) in infants and medically vulnerable children (aged ≤24 months). This post-hoc exploratory analysis examined the incidence of LRTI from RSV and other respiratory pathogens during a 2:1 randomized, double-blind, placebo-controlled, phase 3 study of nirsevimab, in healthy-term and late-preterm (i.e. gestational age ≥35 weeks) infants entering their first RSV season (MELODY).Methods . 3012 participants were randomized to nirsevimab (n = 2009) or placebo (n = 1003).
Lancet
29.11.2024
These data demonstrate that beti-cel can allow patients with genotypes that cause severe β-thalassaemia (β0/β0, β0/β+IVS-I-110, or β+IVS-I-110/β+IVS-I-110) to reach transfusion independence. Beti-cel offers the potential to attain near-normal haemoglobin levels for those with severe forms of TDT, and a potentially curative option without the risks and limitations of allogeneic HSPC transplantation.
American Journal of Respiratory and Critical Care Medicine
28.11.2024
American Journal of Respiratory and Critical Care Medicine, Volume 210, Issue 11, Page 1358-1369, December 1, 2024.
Aktuelle smitsomme sygdomme [5]
Aktuelle smitsomme sygdomme [5]
Medscape Infectious Diseases
30.10.2024
Japan's Shionogi & Co said on Tuesday a global, late-stage study showed its pill-based treatment for COVID-19 was effective in reducing transmission of the. . Reuters Health Information
ProMED
11.02.2025
…e -- Puerto Rico, 2010-2024. MMWR Morb Mortal Wkly Rep. 2024;73:1112-1117. dx.doi.org/10.15585/mmwr.mm7349a1 . 19. Tricou V, Yu D, Reynales H, et al. Long-term efficacy and safety. of a tetravalent dengue vaccine (TAK-003): 4.5-year results from a. phase 3, randomised, double-blind, placebo-controlled trial. Lancet. Glob Health. 2024;12(2):E257-E270. doi.org/10.1016/S2214-109X(23)00522-3 . 20. Pan American Health Organization. Manual for surveillance events.
Medscape Infectious Diseases
9.01.2025
Dr Bishal Gyawali discusses tips for reading a phase 3 clinical trial publication, focusing on the introduction and methods sections. . Medscape Oncology
Medscape Infectious Diseases
8.10.2024
Two different doses of crisugabalin resulted in significantly greater pain reductions in adults with postherpetic neuralgia than placebo in a phase 3 trial. . Medscape Medical News
Medscape Infectious Diseases
5.07.2024
Patients at a high risk for HIV infection who received preexposure prophylactic injections with lenacapavir had 100% efficacy in a phase 3 clinical trial. . Medscape Medical News