Health Condition 1: null- Pneumonia, complicated urinary tract infections and septicemia
Conditions
Interventions
Intervention1: ELORES: Ceftriaxone + Sulbactam +EDTA, Dose: 3gm b.d., Route of administration is Inttravenous as infusion over 90 minutes
Control Intervention1: ELORES: Ceftriaxone+sulbactam+EDTA
Cont
Sponsors
Venus Remedies Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Diagnosis of pneumonia 2 Subjects with suspected cUTI 3 Subjects with suspected sepsis
Exclusion criteria
Exclusion criteria: 1 Subjects with clinically significant cardiovascular, renal, hepatic, gastrointestinal, uncontrolled diabetes mellitus neurological, psychiatric, respiratory ventilator associated pneumonia, HIV, other severally immunocompromized, haematological or malignant disease 2 Subjects with the risk of developing torsade de pointes. Subjects with hypocalcaemia and hypomagnesaemia and uncorrected hypokalemia; clinically relevant bradycardia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To understand the ELORES PK/PD correlation of 90 min infusion regimen in ESBL Positive patient infected with gram-negative bacteriaTimepoint: 90 min | — |
Secondary
| Measure | Time frame |
|---|---|
| To understand the in-vitro TKC and betalactamse inhibition of ESBL pathogen of the serum collected at various time points in ESBL positive patientsTimepoint: 24 hrs | — |
Countries
India
Contacts
Public ContactDr V Satya Suresh Attili
Outcome results
None listed