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Clinical Outcomes of Ceftazidime-Avibactam Alone Versus in Combination for the Treatment of Severe Pneumonia Caused by Drug-Resistant Klebsiella pneumoniae in Critically Ill Patients

Efficacy of ceftazidime-avibactam mono-versus combination therapy in the treatment of pneumonia caused by carbapenem-resistant Klebsiella pneumoniae in critically ill patients: A Prospective Observational Study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/05/110295
Enrollment
100
Registered
2026-05-10
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J150- Pneumonia due to Klebsiella pneumoniae

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Control Intervention1: Nil: Nil

Sponsors

None
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Public ContactDr Gaurav Jain

All India Institute Of Medical Sciences Rishikesh

gauravhld@gmail.com8808631209

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026