This superiority trial is a individually randomized double-blind placebo-controlled parallel group clinical trial to evaluate the role of zinc acting as an adjunct for the treatment of clinical severe infections among infants below two months of age. In India, the study is being conducted at 4 tertiary centres in Delhi (Safdarjung Hospital, Kasturba hospital, MAMC and CNBC). CDSA has taken up the responsibility of quality management to ensure the quality standards of the study as per the project requirements and applicable guidelines.
|Project Title:||Zinc as an adjunct for the treatment of clinical severe infection in infants younger than 2 months|
|• Individually randomized double-blind placebo-controlled parallel group superiority trial
• Multi site (7 hospitals- 4 in Delhi, India and 3 in Nepal)
• Study implemented under Dept of Biotechnology, GOI, Program of Cooperation
• Trial start date: 28 February 2018
|Recruitment ongoing (Enrolments as of 30 Apr 2018: 677 )|
|Study Sites:||1. Maulana Azad Medical College (MAMC), New Delhi
2. Vardhman Mahavir Medical College & Safdarjung Hospital (VMMC & SJH), New Delhi
3. Chacha Nehru Bal Chikitsalaya, (CNBC), New Delhi
4. Kasturba Hospital (KH), Delhi
|• The QM team along with the Coordinating Centre at THSTI successfully initiated the study at the 4 hospital sites in India.
• Conducted GCP training for all site investigators and study staff at the India sites and
supported the investigator for training of research staff in study specific activities.
• Conducted a GCP training for the investigators and study staff for the Nepal sites.
• Supported the project management team in equipment calibration, procurement of
mobile temperature loggers and other temperature monitoring device.
• Prepared and successfully implemented the QM plan along with a monitoring checklist.
- Dr. Nitya Wadhwa
- Mr. Gourav Khurana
- Divya Pillai