Choice of antibiotics for the treatment of infection in newborn babies

Not yet recruiting

Conditions: Bacterial sepsis of newborn, unspecified,

Registration Number: CTRI/2023/08/056272

Lead Sponsor: Banaras Hindu University

Brief Summary: Generally, ampicillin and gentamicin are recommended as initial antibiotic regimen to treat neonatal sepsis. However, due to emerging antimicrobial resistance, it is becoming increasingly difficult to treat neonatal sepsis. This has led to the search for alternative antibiotics which are effective. It is common practice to use piperacillin-tazobactam and amikacin combination to treat neonatal sepsis. However, resistance has also been reported to this combination of antibiotics. In our unit many bacterial isolates are sensitive to levofloxacin. However, no study has been done on the comparative effectiveness and safety of piperacillin-tazobactam and amikacin versus levofloxacin and amikacin. The diagnosis pf neonatal sepsis will be considered as per EMA 2010 criteria. Sepsis work-up will include CBC, CRP, blood culture and culture from other sterile body sites whenever indicated and feasible.Other relevant investigations such as chest x-ray, ABG, renal and liver function tests, coagulogram, cranial sonography, echocardiography will be done as per need. Lumbar puncture will be done if there is strong suspicion of septic meningitis such as seizures, bulging anterior fontanelle. and altered sensorium. We generally perform LP in late onset sepsis and those with positive blood culture unless baby is otherwise well and showing good recovery. LP will delayed for 24-48 hours in hemodynamically unstable neonates. Detailed clinical and laboratory data will be recorded on a predesigned proforma. Complications will be managed as per our unit protocol. The duration of antibiotics will be 5-7 days for clinical sepsis, 10-14 days for culture positive sepsis and 21 days in case of meningitis. We generally do not repeat LP at the completion of therapy.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 180

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 >38.5Â°C or <36Â°C or temperature instability.
2.Cardiovascular instability: Bradycardia, (heart rate <80/min),Tachycardia (heart rate >180/min),Rhythm instability,Reduced urine output (<1ml/kg/hour),Hypotension requiring volume or inotropic support,Mottled skin, Capillary refilling time >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 <4,000/cubic mm or >20,000/cubic mm.
Platelet count <100,000/cubic mm 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 <45mg/dL or 2.5 mmol/L).
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

1.Newborns receiving prophylactic antibiotics 2.Surgical conditions and life threatening congenital malformations 3.Failure to obtain consent 4.Prior exposure of antibiotics.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
hours or earlier if treating physician considers it	7 days
Treatment failure defined as a need for changing initial antibiotics regimen within 72	7 days
necessary in view of rapidly deteriorating clinical	7 days
condition of newborn or patient not cured by 7 days after enrollment.	7 days

Secondary Outcome Measures

Name	Time	Method
1. Mortality during hospitalization	2. Adverse effects of therapy

Trial Locations

Locations (1): SS Hospital
🇮🇳
Varanasi, UTTAR PRADESH, India
SS Hospital
🇮🇳Varanasi, UTTAR PRADESH, India
Prof Ashok Kumar
Principal investigator
09415300370
ashokkumar_bhu@hotmail.com