Choice of Antibiotics for the Treatment of Infection in Newborns

Recruiting

Conditions: Bacterial sepsis of newborn, unspecified,

Registration Number: CTRI/2021/08/035803

Lead Sponsor: Banaras Hindu University

Brief Summary: In this study we will compare the efficacy and safety of Injection ampicillin and gentamicin versus Injection piperacillin-tazobactam and amikacin for the teatment of suspected or confirmed neonatal sepsis.Neonatal sepsis will be suspected on the basis of criteria given by the European Medicines Agency, 2010. Sepsis work up will include CBC, CRP, blood culture, and CSF examination and culture, if needed. Other relevant investigations such as chest xray, ABG, renal and liver function tests, cranial sonography, echocardiography will be done as per need. Newborns with suspected or confirmed sepsis will be randomized to Injection ampicicillin and gentamicin or piperacillin-tazobactam and amikacin, using random permuted blocks of variable size. Randomization sequence will be prepared by a person not involved in study. Newborns will be allocated using serially numbered opaque and sealed envelops. Primary outcome variable of the study is the need for change of initial antibiotic regimen within 72 hours or earlier if treating physician considers it necessary in view of rapidly deteriorating clinical condition of baby. Antibiotics will be changed under the following circumstances(one or more): Failure to improve or worsening of clinical status, new or worsening infiltrates on chest xray, CRP rise of more than 10 mg per decilitre in an unwell newborn, isolation of bacteria resistant to initial antibiotic regimen in an unwell newborn. Complications will be managed as per unit protocol. The duration of antibiotics will be 5-7 days for clinical sepsis, 10-14 days for culture-positive sepsis, and 21 days for meningitis. Lumbar puncture will be done as per the discretion of the treating physician.. LP will be done in those cases where the suspicion of meningitis is high, such as late onset sepsis, or if the blood culture is positive in early onset sepsis. However, generally it will be the discretion of treating physician to subject a newborn to LP. Initial LP will be delayed for 24-48 hours in critically sick newborns. Clinical and laboratory data will be recorded on a pre-designed proforma.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 180

Inclusion Criteria

Clinical Symptoms (2 or more) 1 If core body temperature more than 38.5Â°C or less than 36Â°C or temperature instability.
2 Cardiovascular instability: bradycardia(heart rate below 80/minute) or tachycardia(heart rate above 180/minute) or reduced urinary output (less than 1 ml/kg/hour)or hypotension requiring volume or inotropic support, or mottled skin or capillary refilling time more than 3 seconds 3 Respiratory instability: apnea(cessation of breathing for more than 20 seconds) or tachypnea(respiratory rate more than 60/minute)or episodes or increased oxygen requirement by more than 10% or requirement of ventilatory support 4 Petechial rash or sclerema 5 Feeding intolerance or poor sucking or abdominal distension 6 Central nervous system: irritability or lethargy or hypotonia or seizures 7 Cellulitis or skin ulceration Laboratory signs (2 or more) 1 White blood cells (WBC) count: below 4,000/cubic mm or above 20,000 cubic mm 2 Platelet count below 100,000 cubic mm 3 Immature to total neutrophil ratio above 0.2 4 C reactive protein above 10 mg/L or Procalcitonin levels above hourly reference values after birth 5 Glucose intolerance: hyperglycemia (blood glucose above 180 mg/dL) or hypoglycemia (blood glucose below 45mg/dL) 6 Metabolic acidosis: Base excess (BE) below -10 mEq/L or Serum lactate above 2 mMol/L 7 Chest xray suggestive of bronchopneumonia 8 Cerebrospinal fluid changes suggestive of septic meningitis.

Exclusion Criteria

Newborns receiving antibiotics for 3 days or less 2.
Major congenital malformations 3.
Failure to obtain consent.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment failure will be 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	Within 72 hours

Secondary Outcome Measures

Name	Time	Method
1. Death at 3 days of age	2. Death at 7 days of age

Trial Locations

Locations (1): Second Floor, Neonatal Unit, Department of Pediatrics
🇮🇳
Varanasi, UTTAR PRADESH, India
Second Floor, Neonatal Unit, Department of Pediatrics
🇮🇳Varanasi, UTTAR PRADESH, India
Prof Ashok Kumar
Principal investigator
09415300370
ashokkumar_bhu@hotmail.com