Health Condition 1: J150- Pneumonia due to Klebsiella pneumoniae
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Adults aged 18 years or older with culture-confirmed Carbapenem resistant klebsiella pneumoniae ventilator-associated pneumonia admitted in the ICU. Patients receiving either Ceftazidime-avibactam monotherapy or Ceftazidime-avibactam combination therapy as definitive treatment.
Exclusion criteria
Exclusion criteria: Polymicrobial infections requiring additional systemic antibiotics. Allergy or contraindications to study drugs. Pregnancy or breastfeeding. Expected survival less than or equal to 72 hours. Duration of ceftazidime-avibactam less than or equal to 72hr.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare 30-day mortality in ventilator associated pneumonia due to Carbapenem resistant klebsiella pneumoniae treated with Ceftazidime avibactam monotherapy versus Ceftazidime avibactam combined with specific partner antibiotics like Aztreonam, carbapenems, tigecycline, Fosfomycin, aminoglycosides etc. Timepoint: ICU admission to 30 day post inclusion or death or discharge which ever occurs earlier. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the impact of early initiation and infusion regimens of Ceftazidime-avibactam monotherapy vs combination theraphy on clinical cure and microbiological eradication in Carbapenem resistant klebsiella pneumoniae ventilator associated pneumonia. Timepoint: ICU admission to 30 day post inclusion or death or discharge which ever occurs earlier.;To analyse the outcome variables in each treatment arm.Timepoint: ICU admission to 30 day post inclusion or death or discharge which ever occurs earlier;To assess the cost-effectiveness including drug costs and overall healthcare resource utilization in each treatment arm.Timepoint: ICU admission to 30 day post inclusion or death or discharge which ever occurs earlier;To examine how patient factors influence the 30-day mortality with Ceftazidime-avibactam mono versus combination therapy.Timepoint: ICU admission to 30 day post inclusion or death or discharge which ever occurs earlier.;To evaluate how carbapenemase genotypes influence 30-day mortality among patients receiving Ceftazidime-avibactam mono verses combination therapy.Timepoint: ICU admission to 30 day post inclusion or death or discharge which ever occurs earlier. | — |
Countries
India
Contacts
All India Institute Of Medical Sciences Rishikesh