ReclutandoNCT06818565Registro de ClinicalTrials.gov

Comparison of Efficacy and Safety of Ceftazidime Avibactam Versus Extended Infusions of High Dose Meropenem in Patients of ACLF With Nosocomial Infections.

Acute-On-Chronic Liver Failure

Pregúntale a WCR sobre este estudio Registro oficial ↗

LO ESENCIAL

De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

Tipo de estudio: De intervención
Fase: No aplica
Rango de edad: 18 años - No especificado
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 150 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

Acute on chronic liver failure patients are at high risk for nosocomial infections due to liver dysfunction, which impairs immune responses and increases vulnerability to infections. Key factors contributing to nosocomial infections in ACLF patients include ascites, use of invasive devices, and recent hospitalization, frequent need for broad spectrum antibiotics. Multidrug resistance is a growing issue, making treatment more challenging, common pathogens involved are gram negative bacteria such as Escherichia Coli and Klebsiella pneumoniae. Surveillance data show increasing carbapenem resistant enterobacterales (CRE) infection rates in cirrhotics, with high morbidity and mortality rates. The impact of these nosocomial infections is profound, significantly worsen outcomes in ACLF patients, leading to prolonged hospitalizations, increased health care costs and higher mortality rates. Early detection and effective antibiotic stewardship are essential to manage antibiotic resistance and improve patient outcomes. In this study we aim to compare efficacy and safety of Ceftazidime avibactam versus extended infusions of high dose Meropenem in patients of ACLF with nosocomial infections.

Leer la descripción completa

Hypothesis - We hypothesize that ceftazidime-avibactum would be superior and an effective carbapenem sparing agent compared to extended high dose carbapenems as empirical therapy in management of nosocomial infections caused by carbapenem resistant organisms in patients with ACLF.

Aim -To compare the efficacy and safety of Ceftazidime avibactam and extended infusions of high dose Meropenem as emperical antibiotic in patients of ACLF with nosocomial infections caused by carbapenem resistant organisms.

Primary objective:

• To compare the efficacy of Ceftazidime avibactam over extended infusions of high dose carabapenem as emperical antibiotic in achieving clinical response at day 3 in patients of ACLF with suspected nosocomial infections.

Secondary objectives:

To study the spectrum of nosocomial infections, bacterial DNA and resistance genes in the context of nosocomial infections in ACLF
Proportion of patients requiring escalation/de-escalation of antibiotics at day 3
Incidence of clinical and microbiologic response at day 5 and day 7
Time to escalation of antibiotics in both groups
Transfer to icu, mortality, and progression of organ failures and worsening of AARC scores by grade I, SOFA score by point 2.
Microbiologic outcome (Eradication/Persistence)
To identify biomarkers of host response to empirical antibiotic regimen
Transplant free survival at day 15 and day 28
Proportion of patients made eligible for transplant day 7. A prospective, Randomized Control Trial. Single centre, Open label, Block randomization will be done, it will be implemented by IWRS method. This study will be conducted in Department of Hepatology, ILBS.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

1. Age ≥ 18 years
2. ACLF as per APASL criteria
3. ACLF patients with nosocomial infections caused by carbapenem resistant organism (defined as suspected or documented evidence of infection after 48 hours of hospitalization) requiring antibiotics.

Exclusion Criteria:

1. Severe septic shock with MOF requiring escalation of antibiotics
2. Patients having known allergies to meropenem or Ceftazidime Avibactam
3. Culture sensitivity showing isolate non susceptible to study drug being investigated.
4. Already on either regimen, receiving meropenem or Ceftazidime Avibactam \>48 hours.
5. On mechanical ventilator support PF ratio \< 300.
6. Patients on immunosuppression medication
7. HCC or other malignancies
8. CKD
9. CAD
10. Pregnancy or Lactation
11. Post Liver Transplantation
12. Refusal to consent
13. PLWHA

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: Asignación al azar
Enmascaramiento: Sin enmascaramiento

Meropenem

Meropenem 2gm TDS over 3 hours infusion Teicoplanin 400 mg iv BD for 3 doses f/b 400 mg iv OD

Drug: Meropenem Injection · Drug: Teicoplanin

Ceftazidime avibactam

Ceftazidime avibactam 2.5 gm iv TDS. Teicoplanin 400 mg iv BD for 3 doses f/b 400 mg iv OD

Drug: Ceftazidime-avibactam · Drug: Teicoplanin

Meropenem Injection DRUG

Meropenem 2 gm iv TDS

Ceftazidime-avibactam DRUG

Ceftazidime-avibactam 2.5 gm iv TDS

Teicoplanin DRUG

Teicoplanin 400 mg iv BD 3 doses followed by 400mg iv OD

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Proportion of ACLF patients with nosocomial infection by carbapenem resistant organisms showing clinical response at the end of treatment.

Plazo: Day 3