To compare whether a 1 week course of antibiotics is as good as 2 weeks of antibiotics for septic newborn babies

Phase 3

Completed

• Conditions: Health Condition 1: P369- Bacterial sepsis of newborn, unspecifiedHealth Condition 2: null- Neonatal bacterial septicemia

• Registration Number: CTRI/2017/09/009743
• Lead Sponsor: Indian Council of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-01-30
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 261

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 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 <20 mg/dl or CSF: blood glucose <0.6 or protein >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

Study & Design

• Study Type: Interventional
• Study Design: Not specified