Sammenligning af effektivitet og sikkerhed af ceftazidime avibactam versus udvidede infusioner af meropenem med høj dosis hos patienter af ACLF med nosocomiale infektioner.
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Dr Amanjot Kaur, MD
- Telefonnummer: 01146300000
- E-mail: amanjotbahri@gmail.com
Undersøgelse Kontakt Backup
- Navn: Prof. Rakhi Maiwall, DM
- Telefonnummer: 01146300000
- E-mail: rakhi_2011@yahoo.co.in
Studiesteder
-
-
National Capital Territory of Delhi
-
New Delhi, National Capital Territory of Delhi, Indien, 110070
- Rekruttering
- Institute of Liver & Biliary Sciences (ILBS)
-
Kontakt:
- Dr Amanjot Kaur, MD
- Telefonnummer: 01146300000
- E-mail: amanjotbahri@gmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- On mechanical ventilator support PF ratio < 300.
- Patients on immunosuppression medication
- HCC or other malignancies
- CKD
- CAD
- Pregnancy or Lactation
- Post Liver Transplantation
- Refusal to consent
- PLWHA
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Meropenem
Meropenem 2gm TDS over 3 hours infusion Teicoplanin 400 mg iv BD for 3 doses f/b 400 mg iv OD |
Meropenem 2 gm iv TDS Teicoplanin 400 mg iv BD 3 doses followed by 400mg iv OD |
|
Eksperimentel: Ceftazidime avibactam
Ceftazidime avibactam 2.5 gm iv TDS. Teicoplanin 400 mg iv BD for 3 doses f/b 400 mg iv OD |
Teicoplanin 400 mg iv BD 3 doses followed by 400mg iv OD Ceftazidime-avibactam 2.5 gm iv TDS |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Andelen af ACLF -patienter med nosokomial infektion af carbapenemresistente organismer, der viser klinisk respons ved afslutningen af behandlingen.
Tidsramme: Dag 3
|
Dag 3
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Tid til eskalering eller afskalning af antibiotika
Tidsramme: inden for 3 dage
|
inden for 3 dage
|
|
Progression med hensyn til organdysfunktion/fiasko på dag 5 og 7.
Tidsramme: Dag 5 og 7
|
Dag 5 og 7
|
|
Forekomst af bivirkninger i begge grupper.
Tidsramme: Inden for 7 til 10 dage
|
Inden for 7 til 10 dage
|
|
Varighed af hospital og ICU ophold
Tidsramme: Dag 28
|
Dag 28
|
|
Dødelighed på dag 15 og dag 28
Tidsramme: Dag 15 & 28
|
Dag 15 & 28
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Leversygdomme
- Leversvigt
- Leverinsufficiens
- Leversvigt, akut
- Akut-på-kronisk leversvigt
- Peptider
- Aminosyrer, peptider og proteiner
- Organiske kemikalier
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ring
- Kulhydrater
- Amider
- Glycoconjugates
- beta-lactams
- Lactams
- Carbapenems
- Thienamycins
- Glycopeptider
- Lipoglycopeptider
- Meropenem
- Teicoplanin
- Avibactam, Ceftazidime Drug Combination
Andre undersøgelses-id-numre
- ILBS-ACLF-20
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