ClinicalTrials.gg
RecruitingNCT06818565Updated Nov 9, 2026

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

An interventional study of Meropenem Injection and Ceftazidime-avibactam in Acute-On-Chronic Liver Failure, sponsored by Institute of Liver and Biliary Sciences, India. Recruiting at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by Institute of Liver and Biliary Sciences, India · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started May 2025; still recruiting 1 year 5 months later.
Updated Nov 9, 2026Now RecruitingStart date moved+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.
02

Conditions studied

  • Acute-On-Chronic Liver Failure
03

In context

Acute-On-Chronic Liver Failure

165 studies on the registry are indexed under Acute-On-Chronic Liver Failure; 60 are open to participants now.

This study's planned enrollment of 150 is above the median of 72 across 95 interventional studies indexed under Acute-On-Chronic Liver Failure.

Browse Acute-On-Chronic Liver Failure studies →

Lead sponsor

Institute of Liver and Biliary Sciences, India is the lead sponsor of 302 studies on the registry; 87 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 medication
  7. HCC or other
  8. CKD
  9. CAD
  10. Pregnancy or Lactation
  11. Post Liver Transplantation
  12. Refusal to consent
  13. PLWHA
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Active comparator
    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

  • Experimental
    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

Interventions

  • Meropenem 2 gm iv TDS

  • DrugCeftazidime-avibactam

    Ceftazidime-avibactam 2.5 gm iv TDS

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

06

What researchers measure

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

  5. Mortality at day 15 and day 28

    Time frame: day 15 & 28

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Nov 9, 2026
Sites
1 site added, 1 site removed
Show site
  • Institute of Liver & Biliary Sciences (ILBS) · New Delhi, India
Show 1 removed
  • Institute of Liver & Biliary Sciences (ILBS) · New Delhi, India
Nov 9, 2026
Start date
Feb 10, 2025→May 22, 2025 (actual)
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    Not yet recruiting→Recruiting
    1 site added, 1 site removed
    Show site
    • Institute of Liver & Biliary Sciences (ILBS) · New Delhi, India
    Show 1 removed
    • Institute of Liver & Biliary Sciences (ILBS) · New Delhi, India
    Start date Feb 10, 2025→May 22, 2025 (now actual)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06818565
Responsible party
Sponsor
First posted
Feb 10, 2025
Start date
May 22, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Nov 9, 2026

Study contacts

Dr Amanjot Kaur, MD
Contact
amanjotbahri@gmail.com
01146300000
Prof. Rakhi Maiwall, DM
Contact
rakhi_2011@yahoo.co.in
01146300000

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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