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 |
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. |