Health Condition 1: Z163- Resistance to other antimicrobialdrugs Health Condition 2: A415- Sepsis due to other Gram-negativeorganisms
Conditions
Interventions
Intervention1: Ceftazidime-avibactam + Aztreonam: Nil
Intervention2: Nil: Nil
Intervention3: Nil: Nil
Intervention4: Nil: Nil
Control Intervention1: Other Active Agents (Colistin, Tigecycline, Fosfomy
Sponsors
None
Eligibility
Inclusion criteria
Inclusion criteria: Patients must be more than or equal to 18 years of age, both males and females. Patients have a confirmed diagnosis (blood culture positive) of bloodstream infection (BSI) requiring administration of intravenous (IV) antibacterial therapy. Patients must have an MBL-positive Enterobacterales (for which the imipenem or meropenem minimum inhibitory concentrations is reported as more than or equal to 4 mg/L) isolated from blood within 48 hours prior to enrolment. Patient admitted in ICU. In the case of mixed infection, the patient was allowed to participate in the study if the species were deemed susceptible to Ceftazidime-avibactam + Aztreonam combination (CAZ-AVI + ATM) or the investigator considered that the additional species were colonizers which did not warrant specific treatment. Patients with BSI, with signs and symptoms of systemic infection characterized by at least one of the following: Chills, rigors or fever (temperature of more than or equal to 38.0 C or more than or equal to 100.4 F). Elevated WBC count (more than or equal to 10 000/mm3) or left shift ( more than or equal to 15% immature polymorphonuclear leukocytes).
Exclusion criteria
Exclusion criteria: Patients with positive culture for any infection prior to ICU admission Pregnant and nursing mothers Patient readmitted to the ICU Patient admitted with burns Patient with known HIV seropositivity Patient had a history of serious allergy such as anaphylaxis, angioedema and bronchospasm, or any serious reactions to any systemic antibacterial, which is allowed per protocol. Refusal to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main outcome variable will be 30-day all-cause mortality, defined as the occurrence of death within 30 days from the index blood culture.Timepoint: The main outcome variable will be 30-day all-cause mortality, defined as the occurrence of death within 30 days from the index blood culture. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes will be clinical and microbiological response at 7 days, clinical failure at day 14 and length of ICU and hospital stay (LOS) after the BSI episode. Secondary outcome would also include investigation of the independent risk factors for mortality in MBL producing Enterobacteriaceae, in the entire cohort.Timepoint: Day 7 and Day 14 | — |
Countries
India
Contacts
Public ContactDr Aditi Kaushal
Sir gangaram hospital, new delhi
Outcome results
None listed