Efficacy and Safety of Ampicillin and Ceftriaxone Continuous Infusion Versus Intermittent Infusion for the Treatment of Enterococcus Faecalis Infective Endocarditis (DOBLEI)

Phase IV, open-label, randomized and multicenter clinical trial to prove that patients with Enterococcus faecalis infective endocarditis treated with an antibiotic treatment as a continuous infusion is non-inferior to the standard intermittent infusion regimen, usually administered in hospitalized patients.

开始日期2024-09-30

申办/合作机构

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

[+1]

NCT06513533 / Recruiting临床2/3期IIT

Effect of Dimethyl Fumarate Administered to Patients With Adrenomyeloneuropathy: a Multicenter, Placebo Controlled, Phase IIb/III Trial

The goal of this clinical trial is to determine if dimethyl fumarate is effective in treating motor problems in adults with Adrenomyeloneuropathy. The trial will also assess the safety of dimethyl fumarate and explore the molecular mechanisms underlying the disease. The primary questions it aims to answer are:
* Does dimethyl fumarate improve motor problems in participants?
* What medical issues do participants experience while taking dimethyl fumarate? Researchers will compare the effects of dimethyl fumarate to a placebo (a substance that looks like the drug but contains no active ingredients) to evaluate its effectiveness in treating Adrenomyeloneuropathy.
Participants will:
* Take either dimethyl fumarate or a placebo daily for 36 months.
* Visit the clinic at the start of the trial, then at 3 months, 6 months, and every 6 months thereafter for checkups and tests.

开始日期2024-04-23

申办/合作机构

Spanish Clinical Research Network

[+2]

NCT06378190 / Recruiting临床1/2期

Multicentre Phase I/IIa Study of Infusion of Autologous Peripheral Blood T Lymphocytes Expanded and Genetically Modified Using Sleeping Beauty Family Transposons to Express a Chimeric Antigenic Receptor With Anti-CD19 Specificity Conjugated to the 4-1BB Co-stimulatory Region and CD3z and huEGFRt Signal Transmission (TranspoCART19) in Patients With Relapsed or Refractory B-cell Lymphoma

The goal of this clinical trial is to to evaluate the safety and efficacy of TranspoCART19 in patients with relapsed/refractory B-lymphoma. The main questions it aims to answer are:
Maximum tolerated dose (MTD) Response rates Participants will be treated with the investigational medicinal product and will be followed for 36 months.

开始日期2024-03-11

申办/合作机构

Instituto de InvestigaciÃ³n BiomÃ©dica de Salamanca - IBSAL

[+3]

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2023-10-01·Nature medicine1区 · 医学

Cloxacillin plus fosfomycin versus cloxacillin alone for methicillin-susceptible Staphylococcus aureus bacteremia: a randomized trial.

1区 · 医学

Article

作者: Euba, Gorane ; Pérez-Rodríguez, Maria Teresa ; Tebé, Cristian ; Garcia-País, Maria José ; Gomez-Zorrilla, Silvia ; Videla, Sebastian ; Izquierdo-Cárdenas, Álvaro ; López-Cortés, Luis Eduardo ; Padullés, Ariadna ; Gioia, Francesca ; Gomila-Grange, Aina ; Oriol, Isabel ; Miró, Josep M ; Jover-Sáenz, Alfredo ; San-Juan, Rafael ; Cuervo, Guillermo ; Aguado, José María ; Iftimie, Simona ; Dietl, Beatriz ; Carratalà, Jordi ; Boix-Palop, Lucia ; Berbel, Damaris ; García-Pardo, Graciano ; Gasch, Oriol ; Pallarès, Natalia ; Grillo, Sara ; Goikoetxea, Ane Josune ; Pedro-Botet, Maria Luisa ; Hereu, Pilar ; Loeches, Belén ; López-Contreras, Joaquín ; Morata, Laura ; Pujol, Miquel

Treatment failure occurs in about 25% of patients with methicillin-susceptible Staphylococcus aureus (MSSA) bacteremia. We assessed whether cloxacillin plus fosfomycin achieves better treatment success than cloxacillin alone in hospitalized adults with MSSA bacteremia. We conducted a multicenter, open-label, phase III-IV superiority randomized clinical trial. We randomly assigned patients (1:1) to receive 2 g of intravenous cloxacillin alone every 4 h or with 3 g of intravenous fosfomycin every 6 h for the initial 7 days. The primary endpoint was treatment success at day 7, a composite endpoint with the following criteria: patient alive, stable or with improved quick Sequential Organ Failure Assessment score, afebrile and with negative blood cultures for MSSA, adjudicated by an independent committee blinded to treatment allocation. We randomized 215 patients, of whom 105 received cloxacillin plus fosfomycin and 110 received cloxacillin alone. We analyzed the primary endpoint with the intention-to-treat approach in 214 patients who received at least 1 day of treatment. Treatment success at day 7 after randomization was achieved in 83 (79.8%) of 104 patients receiving combination treatment versus 82 (74.5%) of 110 patients receiving monotherapy (risk difference 5.3%; 95% confidence interval (CI), -5.95-16.48). Secondary endpoints, including mortality and adverse events, were similar in the two groups except for persistent bacteremia at day 3, which was less common in the combination arm. In a prespecified interim analysis, the independent committee recommended stopping recruitment for futility prior to meeting the planned randomization of 366 patients. Cloxacillin plus fosfomycin did not achieve better treatment success at day 7 of therapy than cloxacillin alone in MSSA bacteremia. Further trials should consider the intrinsic heterogeneity of the infection by using a more personalized approach. ClinicalTrials.gov registration: NCT03959345 .

2023-02-08·Clinical Infectious Diseases

Tenofovir Disoproxil Fumarate/Emtricitabine and Baricitinib for Patients at High Risk of Severe Coronavirus Disease 2019: The PANCOVID Randomized Clinical Trial

Article

作者: Martínez, Patricia ; Ciudad, Marianela ; Carcas, Antonio J ; Borobia, Alberto M ; Goikoetxea, Ane Josune ; Estrada, Vicente ; Marcelo, Cristina ; Ibarrola, Marta ; de la Calle-Prieto, Fernando ; del Álamo, Mikel ; Merino, Esperanza ; Rivera, María A ; Ibarra, Sofía ; Guijarro, Carlos ; Ruiz-Muñoz, Manuel ; Queiruga-Parada, Javier ; Velasco, María ; Díaz-Brasero, Ana ; Montejano, Rocío ; Novella, María ; Gutiérrez, Ángela ; de Miguel, Marta ; Díez, Cristina ; Soler, Llanos ; Jiménez-González, María ; Torralba, Miguel ; Moreno, Santiago ; Ryan, Pablo ; Marcos, Javier ; Arribas, José R ; González-Ruano, Patricia

AbstractBackgroundThis study was designed to evaluate if patients with high risk for severe coronavirus disease 2019 (COVID-19) would benefit from treatment with tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) followed by baricitinib in case of hypoxemia and systemic inflammation.MethodsPANCOVID is an open-label, double-randomized, phase 3 pragmatic clinical trial including adults with symptomatic COVID-19 with ≥2 comorbidities or aged ≥60 years and was conducted between 10 October 2020 and 23 September 2021. In the first randomization, patients received TDF/FTC or no TDF/FTC. In the second randomization, patients with room air oxygen saturation <95% and at least 1 increased inflammatory biomarker received baricitinib plus dexamethasone or dexamethasone alone. The primary endpoint was 28-day mortality. Main secondary endpoint was 28-day disease progression or critical care unit admission or mortality. The trial was stopped before reaching planned sample size due to the decrease in the number of cases and a mortality rate substantially lower than expected.ResultsOf the 355 included participants, 97% were hospitalized at baseline. Overall, 28-day mortality was 3.1%. The 28-day mortality relative risk (RR) for participants treated with TDF/FTC was 1.76 (95% confidence interval [CI], .52–5.91; P = .379); it was 0.42 (95% CI, .11–1.59; P = .201) for those treated with baricitinib. The 28-day RR for the main secondary combined endpoint for participants treated with TDF/FTC was 0.95 (95% CI, .66–1.40; P = .774); it was 0.90 (95% CI, .61–1.33; P = .687) for those treated with baricitinib.ConclusionsOur results do not suggest a beneficial effect of TDF/FTC; nevertheless, they are compatible with the beneficial effect of baricitinib already established by other clinical trials.Clinical Trials RegistrationEudraCT: 2020-001156-18.

2023-01-01·Frontiers in public health

Characteristics of clinical trials of influenza and respiratory syncytial virus registered in ClinicalTrials.gov between 2014 and 2021.

Article

作者: Maestro de la Calle, Guillermo ; Menéndez-Orenga, Miguel ; Calderón, Enrique J ; Ruíz-Ruigómez, María ; Lalueza, Antonio ; Lora, David ; García-Reyne, Ana

The randomized clinical trial (RCT) is the ideal and mandatory type of study to verify the effect and safety of a drug. Our aim is to examine the fundamental characteristics of interventional clinical trials on influenza and respiratory syncytial virus (RSV). This is a cross-sectional study of RCTs on influenza and RSV in humans between 2014 and 2021 registered in ClinicalTrials.gov. A total of 516 studies were identified: 94 for RSV, 423 for influenza, and 1 for both viruses. There were 51 RCTs of RSV vaccines (54.3%) and 344 (81.3%) for influenza virus vaccines (p < 0.001). Twelve (12.8%) RCTs for RSV were conducted only with women, and 6 were conducted only with pregnant women; for RCTs for influenza, 4 (0.9%) and 3, respectively. For RSV, 29 (31%) of the RCTs were exclusive to people under 5 years of age, and 21 (5%) for influenza virus (p < 0.001). For RSV, there are no RCTs exclusively for people older than or equal to 65 years and no phase 4 trials. RCTs on influenza virus and RSV has focused on vaccines. For the influenza virus, research has been consolidated, and for RSV, research is still in the development phase and directed at children and pregnant women.

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