Estudio multicéntrico aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de CAL02 administrado por vía intravenosa en adición al tratamiento estándar en sujetos con neumonía bacteriana grave adquirida en la comunidad (NBGAC)

Activo, no reclutaFase 2ClinicalTrials.gov

ID: NCT05776004Tipo: INTERVENTIONALInicio: 22 de jul de 2023Fin estimado: 7 de sept de 2026

Resumen

Se trata de un estudio controlado con placebo para evaluar la adición de CAL02 al tratamiento estándar en el tratamiento de sujetos hospitalizados con diagnóstico de neumonía bacteriana grave adquirida en la comunidad (NBGAC) que requieren medidas de cuidados intensivos.

Descripción detallada

Los sujetos con diagnóstico de NBGAC que requieran medidas de cuidados intensivos recibirán 2 infusiones intravenosas de CAL02 (dosis entre 13,7 y 24 mg/kg ajustada por peso) administradas con 24-26 horas de intervalo, o 2 infusiones intravenosas de placebo. Además, todos los sujetos recibirán el tratamiento estándar (SOC) para la NBGAC según las guías científicas. Las medidas de cuidados intensivos proporcionan atención médica y de enfermería intensiva y especializada, capacidad de monitoreo continuo durante 24 horas al día y múltiples modalidades de soporte fisiológico de órganos para mantener con vida a los pacientes grave o críticamente enfermos.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

male or females older than 18 years old
Body Weight 40 - 140 kg;
clinical diagnosis of CABP diagnosed less than or equal to 48 hrs after hospital admission;
presence of at least one of the protocol defined SCABP severity criteria:
at least two clinical symptoms
at least 2 vital sign abnormalities
at least one finding of other clinical signs/laboratory abnormalities
radiographic evidence in support of pneumonia with likely bacterial origin
presence of at least one of the following severity criteria based on protocol defined SCABP:
respiratory failure requiring invasive mechanical ventilation support
respiratory failure requiring non-invasive positive pressure ventilation support
respiratory failure requiring high-flow oxygen
septic shock requiring treatment with vasopressors at therapeutic doses for at least 2 hours
requires critical care for management of SCABP
onset of severity criteria less than 48 hours from diagnosis of CABP or upon discussion with medical monitor
written informed consent before any study-specific assessment is performed

Criterios de exclusión

subjects with ventilator-associated pneumonia, aspiration pneumonia, fungal pneumonia, viral pneumonia (viral coinfection may be exempted subject to discussion with medical monitor);
subjects more than 12 hours from the diagnosis of SCABP;
SOFA score greater than 12 points
subject received IV antibiotics for CABP/SCABP for more than 48 hours at the time of randomization if sensitivity supports appropriate empiric therapy chosen and administered
renal replacement therapy
known hypersensitivity to liposomal formulations
end-stage neuromuscular disorders, tracheostomy, known bronchial obstruction, post-operative aspiration pneumonia, cystic fibrosis, known or suspected pneumocystis jirovecii or tuberculosis pneumonia, post organ transplant, or primary or metastatic malignancy in the lungs
current or recent participation in an investigational study (within 30 days of screening or 5 half-lives of the investigational compound, whichever is longer)
known liver dysfunction, chronic liver disease with Child Pugh C or esophageal varices
moribund clinical conditions at the time of screening or time of the first study medication infusion
refractory septic shock at the time of randomization
subject has any medical disease or condition that, in the opinion of the investigator, compromises the subject's safety or compromises the interpretation of results
nursing and pregnant women
women of childbearing potential and non-surgically sterile males

Intervenciones

drug

CAL02

CAL02 consists of a mixture of 2 liposomes and is a non-biological bacterial virulence neutralizer.

drug

Placebo

Physiological 0.9% sodium chloride solution for iv administration

Ubicaciones

Hospital Interzonal General de Agudo Dr Jose Pena

Bahía Blanca, Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Hospital Misericordia Nuevo Siglo

Córdoba, Argentina

Hospital Central

Mendoza, Argentina

Patrocinadores

PrincipalEagle Pharmaceuticals, Inc.

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