Health Condition 1: B96- Other bacterial agents as the cause of diseases classified elsewhere Health Condition 2: B961- Klebsiella pneumoniae [K. pneumoniae] as the cause of diseases classified elsewhere Health Condition 3: B962- Escherichia coli [E. coli ] as thecause of diseases classified elsewhere Health Condition 4: B965- Pseudomonas (aeruginosa) (mallei)(pseudomallei) as the cause of diseases classified elsewhere Health Condition 5: B968- Other specified bacterial agents as the cause of di
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Chacha Nehru Bal Chikitsalaya
Eligibility
Inclusion criteria
Inclusion criteria: All neonates with confirmed positive culture of any sterile body fluid like blood, respiratory ,urinary tract caused by multidrug or extensively drug resistant gram negative bacteria and susceptibility confirmed to colistin
Exclusion criteria
Exclusion criteria: Children with major congenital anomalies, severe renal dysfunction at baseline . Cases with colistin administered less than 48 hours. Cases with CSF culture emerged multidrug or extensively drug resistant organisms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical cure at day 14 (defined as resolution of symptoms or signs of infection without need of antibiotic change or escalation.Timepoint: Clinical cure at day 14 (defined as resolution of symptoms or signs of infection without need of antibiotic change or escalation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Microbiological Eradication as repeat culture report negative for Multidrug or Extensively drug resistant organisms.Timepoint: 72 hour , day 7 , day 14;All cause mortalities.Timepoint: 48 hours to 14 days or till Discharge.;Neonates developing Acute Kidney Injury as per N KDIGOTimepoint: 24 hour , 72 hour , day 7;Neonates developing hypocalcemia ,hypomagnesemia & dyselectrolytemia.Timepoint: 24 hour ,72 hour , day 7;Neonates requiring additional antibiotics in monotherapy group.Timepoint: starting of therapy to end of therapy | — |
Countries
India
Contacts
Public ContactGoutham Shivarag
Chacha Nehru Bal Chikitsalaya
Outcome results
None listed