Health Condition 1: P369- Bacterial sepsis of newborn, unspecified Health Condition 2: null- Neonatal bacterial septicemia
Conditions
Interventions
Intervention1: 7-day antibiotics: Neonates with uncomplicated culture-proven bacterial sepsis due to organism other than Staphylococcus aureus and who have received 7 days of intravenous antibiotics u
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria for the initial observational period: 1. Neonates aged 0-28 days, either inborn or outborn, who are currently admitted in the Neonatal unit of the centre, 2. Whose birth weight is greater than 1500 grams (it should be reliably ascertained from records of a hospital), 3. Whose residence is within approximately 15 kms from the centre, so that the infant can be brought back to the centre for follow up. 4. Who have suspected septicemia for which a conventional or BACTEC/BACTALERT blood culture is sent and for which the treating physician decides to start antibiotics Randomization criteria applicable after 7 days of therapy of above patients with sensitive antibiotics: 1.Positive blood culture other than Staphylococcus aureus 2.No signs and symptoms of sepsis from end of day 5 through end of day 7 of starting sensitive antibiotics (This will be on day 5 through 7 for those who have improved and will be, for instance, day 8 through 10 for those whose initial empiric antibiotics were resistant requiring a change in antibiotic on day 3 of enrollment)
Exclusion criteria
Exclusion criteria: Exclusion criteria for the initial observational period: 1. Central Nervous System infection (meningitis will be defined as one or more of CSF cell count >= 25 per microliter with > 60% neutrophils; glucose 150 mg/dL in term or >180 mg/dL in preterm or positive gram stain report) 2. Septic arthritis, osteomyelitis or deep-seated abscess as clinically judged by the treating team 3. Life threatening congenital malformations as judged by the principal investigator of the centre Exclusion criteria for randomization applicable after 7 days of therapy of above patients with sensitive antibiotics: 1. Sterile blood culture 2. Suspected contaminants in blood culture. 3. Growth of Staphylococcus aureus in blood culture 4. Growth of fungal organism in blood culture 5. Diagnosis of meningitis, septic arthritis, osteomyelitis, abscess 6. Has not gone into remission on day 5 or have recurrence of symptoms from day 5 through day 7 7. If the empiric antibiotic is resistant but neonate has shown improvement of signs and symptoms of sepsis and there is ambiguity regarding in vivo sensitivity of antibiotic use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â??Definite or probable relapseâ??. Definite relapse will be defined as the occurrence of an episode of illness within the 21-day period after antibiotic completion in which the same organism with similar antibiogram is grown, as in the original episode. Probable relapse will be defined as the occurrence of an episode of illness within the 21-day period that is diagnosed to be bacterial sepsis based on clinical features and investigations, in the setting of a sterile blood culture.Timepoint: 0 to 21 day period after completion of allocated antibiotic ourse | — |
Secondary
| Measure | Time frame |
|---|---|
| "Definite or probable" relapse within 28 days after randomization. "Definite or probable" relapse will be defined as above. This will be analyzed as per intention-to-treat.Timepoint: 0 to 28 day period after randomization;"Definite or probable" relapse within 35 days after randomization. "Definite or probable" relapse will be defined as above. This will be analyzed as per intention-to-treat.Timepoint: 0 to 35 day period after randomization;Adverse events: adverse events will be graded according to severity, defined a priori.Timepoint: 0 to 35 day period after randomization;â??Definite or Probable relapseâ?? within 21 days after antibiotic completion. Probable relapse will be defined as the occurrence of an episode of illness that is diagnosed to be clinical diagnosis of bacterial sepsis, in the setting of a sterile blood culture. This will be also be analyzed both as per protocol and as per intention-to-treat.Timepoint: 0 to 21 day period after completion of allocated antibiotic course.;â??Definite or Probable relapseâ?? within 28 days after antibiotic completion. Probable relapse will be defined as the occurrence of an episode of illness that is diagnosed to be clinical diagnosis of bacterial sepsis, in the setting of a sterile blood culture. This will be also be analyzed both as per protocol and as per intention-to-treat.Timepoint: 0 to 28 day period after completion of allocated antibiotic course.;Definite relapse within 28 days after randomization. Definite relapse will be defined as above. This will be analyzed as per intention-to-treat.Timepoint: 0 to 28 day period after randomization;Definite relapse within 35 days after randomization. Definite relapse will be defined as above. This will be analyzed as per intention-to-treat.Timepoint: 0 to 35 day period after randomization.;Secondary infections due to bacterial organisms other than the original etiologic organism or with a different antibiogram or a fungal organismTimepoint: 0 to 35 day period from randomiza | — |
Countries
India
Contacts
Public ContactSourabh Dutta
Postgraduate Institute of Medical Education and Research
Outcome results
None listed