Administrative information
Title {1}x | Comparison of the efficacy of a 7-day versus a 14-day course of intravenous antibiotics in the treatment of uncomplicated neonatal bacterial sepsis: a randomized controlled non-inferiority trial |
Trial registration {2a and 2b}. | Clinical Trials Registry-India (CTRI): registration number CTRI/2017/09/009743 ClinicalTrials.gov: ID NCT03280147. |
Protocol version {3} | Version 3, 5 February 2019 |
Funding {4} | Funded by Indian Council of Medical Research (ICMR), Ansari Nagar, New Delhi, India |
Author details {5a} | Sourabh Duttaa, Sushma Nangiab, Mamta Jajooc, Geeta Gathwalad, Saudamini Nesargie, Mangalabharathi Sundaramf, Praveen Kumara, Arvind Sailib, Dipti Kumarc, Poonam Dalald, Suman Rao P. N.e, Ramya Shanmugamf, Pallab Raya, Valinderjeet Singh Randhawab, Karnika Saigalc, Madhu Sharmad, Savitha Nagaraje, Devasena Radhakrishnanf. a Postgraduate Institute of Medical Education and Research, Chandigarh, India b Lady Hardinge Medical College & Kalawati Saran Children’s Hospital, New Delhi, India c Chacha Nehru Bal Chikitsalaya, New Delhi, India d Postgraduate Institute of Medical Sciences, Rohtak, India e St John’s Medical College and Hospital, Bengaluru, India f Institute of Child Health, Madras Medical College, Chennai |
Name and contact information for the trial sponsor {5b} | Director-general, ICMR, V. Ramalingawami Bhawan, Ansari Nagar, Post Box Bo. 4911 New Delhi - 110029 |
Role of sponsor {5c} | ICMR will have no role in study design, data collection, data management, analysis and interpretation of data, writing of the report or decision to submit the report for publication. |
Introduction
Background and rationale {6a}
Objectives {7}
Trial design {8}
Methods: Participants, interventions, and outcomes
Study setting {9}
Eligibility criteria {10}
Eligibility criteria for the observational part of the study
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Neonates aged 0–28 days, who are currently admitted in the neonatal unit of the center,
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Birth weight ≥1000 g,
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Residence is within approximately 15 km from the center, so that the infant can be brought back to the center for follow-up.
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Suspected septicemia for which a conventional or BACTEC/BACT-ALERT blood culture is sent and for which the treating physician decides to start antibiotics.
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Central Nervous System infection [meningitis will be defined as one or more of: cerebrospinal fluid (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 or positive culture report
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Septic arthritis, osteomyelitis, or deep-seated abscess as clinically judged by the treating team
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Life-threatening congenital malformations as judged by the principal investigator of the center.
Data of observational part of the study
Randomization criteria
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Suspected contaminants in blood culture.
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Growth of Staphylococcus aureus in blood culture
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Growth of fungal organism in blood culture
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Diagnosis of meningitis, septic arthritis, osteomyelitis, abscess
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Ambiguity regarding in vivo sensitivity of antibiotics used