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Comparing the effects of ceftazidime-avibactam and aztreonam as continuous versus intermittent doses in critically ill patients with severe infections caused by drug resistant bacteria.

CONTINUOUS VS INTERMITTENT INFUSION OF CEFTAZIDIME-AVIBACTAM AND AZTREONAM IN CRITICALLY ILL PATIENTS WITH CARBAPENEM RESISTANT GRAM NEGATIVE INFECTION: A PROSPECTIVE OBSERVATIONAL COHORT STUDY - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/088572
Enrollment
60
Registered
2025-06-10
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Health Condition 1: A415- Sepsis due to other Gram-negativeorganisms

Interventions

Intervention1: Nil: Nil Intervention2: Continuous infusion Group: Eligible patients with septic shock will be identified and recruited from intensive care unit (ICU). After obtaining informed consent,

Sponsors

Dr.kunchala anand
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria 1.The patient aged more than 18 years 2.The patient has a documented GNB infection with carbapenem resistance and synergy positive 3.The patient initiated on Ceftazidime avibactam with or without aztreonam to treat the episode of infection 4.Eligible participants expected to remain in the ICU for atleast 48 hours

Exclusion criteria

Exclusion criteria: Exclusion Criteria 1 Patient aged less than 18 years 2 The patient has received Ceftazidime avibactam and aztreonam for more than 24 hours during current infectious episode 3 The patient is known or suspected to be pregnant 4 The patient has a known allergy to beta Lactam Antibiotics 5 Chronic Renal Failure on Maintenance Dialysis 6 Lack Of Consent

Design outcomes

Primary

MeasureTime frame
Clinical success on day 14Timepoint: Clinical success is defined as Patient s survival status, Hemodynamic stability systolic blood pressure more than 90 mm Hg without requiring vasopressor support, Enhancement in SOFA score Specifically, for a baseline SOFA score more than 3, a minimum 30 percent improvement in score is necessary, while for a SOFA score less than 3, a reduction of at least 1 point is required, Patients not meeting all these success criteria will be categorized as experiencing clinical failure by day 14.

Secondary

MeasureTime frame
1 Microbiological relapse 2 Microbiological failure. 3 Vasopressors free days 4 Mechanical ventilator free days 5 ICU free days 6 ICU mortality 7 In-hospital mortality Timepoint: Outcomes will be assessed on day 7 & day 14 Microbiological failure: Characterized by the recurrence of bacteria phenotypically identical to the initial isolates on or after day 7. Microbiological relapse : Defined as recurrence of bacteria phenotypically identical to the initial isolate after a previous negative culture within 14 days.

Countries

India

Contacts

Public ContactDR RENUKA MK

sri ramachandra medical education and research

hod.criticalcare@sriramachandra.edu.in8056126336

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026