Health Condition 1: P369- Bacterial sepsis of newborn, unspecified
Conditions
Interventions
Intervention1: Injection Levofloxacin and Amikacin: Injection Levofloxacin
and Amikacin will be
administered to newborns with
suspected or confirmed sepsis
using standard doses adjusted to gestational
Sponsors
Banaras Hindu University
Eligibility
Inclusion criteria
Inclusion criteria: The diagnosis of neonatal sepsis will be based on the presence of the following criteria, as defined by the European Medicines Agency (2010). Per EMA criteria there should be at least 2 clinical and 2 laboratory signs for making a diagnosis of suspected or confirmed neonatal sepsis. These criteria are as follows: Clinical symptoms (2 or more) 1. If core body temperature >38.5°C or 2. Cardiovascular instability: Bradycardia, (heart rate 180/min), Rhythm instability, Reduced urine output ( 3 seconds 3. Respiratory instability: Apnea (cessation of breathing for >20 seconds), Tachypnea (respiratory rate >60/min, Increased oxygen requirement >10%, Requirement of ventilatory support 4. Petechial rash or sclerema. 5. Feed intolerance or poor sucking or abdominal distension. 6. Central nervous system: Irritability, Lethargy, Hypotonia, Seizure 7. Cellulitis or skin ulceration. 8. Non-specific: irritability or lethargy or hypotonia Laboratory signs (2 or more) 1. White blood cells (WBC) count 20,000/cubic mm. 2. Platelet count 3. Immature to total neutrophil ratio >0.2 4. C-reactive protein >10 mg/L 5. Glucose intolerance confirmed at least 2 times: hyperglycemia (blood glucose >180 mg/dL or 10mmol/L) or hypoglycemia (blood glucose 6. Metabolic acidosis: Base excess (BE) below -10 mEq/L or Serum lactate >2 mmol/L. 7. Chest X-ray suggestive of bronchopneumonia 8. Cerebrosinal fluid changes suggestive of septic meningitis.
Exclusion criteria
Exclusion criteria: 1. Newborns receiving prophylactic antibiotics 2. Surgical conditions and life threatening congenital malformations 3. Failure to obtain consent 4. Prior exposure of antibiotics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment failure defined as a need for changing initial antibiotics regimen within 72 hours or earlier if treating physician considers it necessary in view of rapidly deteriorating clinical condition of newborn or patient not cured by 7 days after enrollment.Timepoint: 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mortality during hospitalization 2. Adverse effects of therapy 3. Duration of hospitalizationTimepoint: During hospitalization | — |
Countries
India
Contacts
Public ContactAyush Yadav
Banaras Hindu University
Outcome results
None listed