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

ConditionAcute-On-Chronic Liver Failure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Liver and Biliary Sciences, India

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

ACLF as per APASL criteria

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.

Disqualifiers

Severe septic shock with MOF requiring escalation of antibiotics

Patients having known allergies to meropenem or Ceftazidime Avibactam

Culture sensitivity showing isolate non susceptible to study drug being investigated.

Already on either regimen, receiving meropenem or Ceftazidime Avibactam >48 hours.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: MeropenemActive comparator 2 interventions
Group B: Ceftazidime avibactamExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Day 3

Secondary outcomes

1

Time to escalation or descalation of antibiotics

Time frame
within 3 days
2

Progression in terms of organ dysfunction/failure at day 5 and 7.

Time frame
day 5 and 7
3

Incidence of adverse events in both groups.

Time frame
within 7 to 10 days
4

Duration of hospital and ICU stay

Time frame
day 28

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Liver and Biliary Sciences, India

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: