Health Condition 1: A415- Sepsis due to other Gram-negativeorganisms
Conditions
Interventions
Intervention1: Ceftazidime-avibactam 2.5g every 8hrly: Drug will be administered every 8hrly for first 48 hrs and further doses will be modified based on renal function estimated using Cockroft gault
Sponsors
Glenmark Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: a. Patients diagnosed with Sepsis b. Patients with Acute kidney injury according to KDIGO criteria. c. The patient or approved proxy is able to provide informed consent.
Exclusion criteria
Exclusion criteria: a. Treatment is not with the intent to cure the infection (that is, palliative care is an exclusion). b. Patients with Chronic kidney disease on dialysis c. Pregnancy or breast-feeding. d. Use of study drug within last 7 days before recruitment in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality rate will be measured as the number of deaths on or before 28 days after inclusion in the study.Timepoint: On day 28 after inclusion in the study, the primary outcome will be measured as stated above. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical cure is defined as a patient is alive, with resolution or substantial improvement of baseline signs & symptoms (defervescence), & a delta sequential organ function assessment (?SOFA) score of less than 2, with or without microbiological cure, & no requirement of rescue antibiotic therapy.Timepoint: Clinical cure will be measured on Day 14 & 28 of inclusion. | — |
Countries
India
Contacts
Public ContactRacha Amarthya sree
AIG Hospitals
Outcome results
None listed