Zinc in addition to antibiotics for treating newborn babies with sepsis

• Register: CTRI
• Last refreshed on: 17 October 2022
• Main ID: CTRI/2017/02/007966
• Date of registration: 27-02-2017
• Prospective Registration: Yes
• Primary sponsor: Translational Health Science and Technology Institute
• Public title: Zinc in addition to antibiotics for treating newborn babies with sepsis
• Scientific title: Zinc as an adjunct for the treatment of clinical severe infection in infants younger than 2 months
• Date of first enrolment: 02-03-2017
• Target sample size: 4140
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=17717
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
• Phase: Phase 3

Countries of recruitment

India, Nepal

Contacts

• Name: Dr Nitya Wadhwa
• Affiliation: Translational Health Science and Technology Institute

• Name: Dr Shinjini Bhatnagar
• Affiliation: Translational Health Science and Technology Institute

Key inclusion & exclusion criteria

Inclusion criteria: We have adapted the inclusion criteria from the WHO IMCI and IMNCI to identify very sick infants aged 3 days to 59 days with clinical severe infection

1)Low body temperature less than 35.5 deg Celsius AND, OR

2)Movement only when stimulated AND, OR

3)Stopped feeding well AND, OR

4)Severe chest indrawing AND, OR

5) Axillary temperature more than or equal to 38.0 deg Celsius and Infant should have been well at some point from birth till the current episode of illness
Exclusion criteria: 1) Surgical or life-threatening malformation or condition that will interfere with administration of oral or oro-gastric (OG) or naso-gastric (NG) intervention

2) Infants requiring surgical intervention or admission outside of pediatric ward for management

3) Documented evidence of having received more than 1mg of elemental zinc per day in the last 48 hours

4) Documented evidence of having received injectable antibiotics for 48 hours or more for this illness episode

5) Weight at presentation less than 1500 gm

6) infants requiring exchange transfusion



Those infants who fulfill the criteria of clinical severe infection and do not have any exclusion criteria but are very sick and not allowed oral or nasogastric intervention will not be enrolled immediately but will be observed during a stabilization period when they will be observed by the study nurse every 8th hourly for a maximum period of 24 hours of

stabilization. Infants who have been stabilized and allowed orally, anytime within the 24 hour stabilization period and who after stabilization continue to have at least one sign of clinical severe infection, no exclusion criteria and whose parents or guardians have given written informed consent for participation will now fulfill the eligibility criteria



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: A418- Other specified sepsis Health Condition 2: A414- Sepsis due to anaerobes Health Condition 3: A413- Sepsis due to Hemophilus influenzae Health Condition 4: A415- Sepsis due to other Gram-negativeorganisms Health Condition 5: A411- Sepsis due to other specified staphylococcus Health Condition 6: A410- Sepsis due to Staphylococcus aureus Health Condition 7: A412- Sepsis due to unspecified staphylococcus Health Condition 8: A419- Sepsis, unspecified organism

Intervention(s)

Intervention1: Zinc sulphate dispersible tablet: 5 mg elemental zinc given as dispersible zinc sulphate tablets twice a day for a total of 14 days.
Control Intervention1: Placebo dispersible tablets: Placebo dispersible tablets twice a day for a total of 14 days.

Primary Outcome(s)

1) Case fatality, which is death due to any cause and at any time after enrolment while hospitalized for the illness episode.

2) extended case fatality risk, i.e. the risk of death until 12 weeks from the day of enrolmentTimepoint: 1) Death at any time during hospitalization for this illness episode

2) Death at any time from enrolment upto 12 weeks from day of enrolment

Secondary Outcome(s)

Cessation of signs of clinical severe infectionTimepoint: During

hospitalization

Death at any time after discharge

from hospital until 12 weeks from day of enrollment

Timepoint: Discharge to

end of study

period

DischargeTimepoint: From

hospitalization

Failure of primary treatment, defined as need to

change antibiotics or requirement for life support or death

Timepoint: During

hospitalization

Severe illness at any time after discharge from

hospital until 12 weeks from day of enrolment

Timepoint: Discharge to

end of study

period

Health gain, financial risk protection and cost effectiveness analysisTimepoint: Enrollment to end of study period (until 12 weeks from day of enrollment)

Stool for enteropathogens and characterization of intestinal microbiome/metagenomeTimepoint: Enrolment - V1

Immunobiological readouts to evaluate effect of zincTimepoint: During

hospitalization

Secondary ID(s)

U1111-1187-6479

RCN/ZINCSEVINF/02/2015 Version 5.0 dated: 18-01-2021

Source(s) of Monetary Support

1. The Research Council of Norway under the research Grant on Global Health and Vaccination research (GLOBVAC) Department for Health, N-0131 Oslo Norway And 2. Centre for Intervention Science in Maternal and Child Health (CISMAC) is a consortium funded by Research Council of Norway and anchored at the Centre for International Health (CIH), University of Bergen, Norway

Infrastructural support: 1) THSTI Faridabad 2) VMMC and Safdarjung Hospital New Delhi 3)Chacha Nehru Bal Chikitsalaya, Delhi 4)Maulana Azad Medical College New Delhi 5) Kasturba Hospital Delhi 6) Institute of Medicine, Tribhuvan University Nepal 7) Patan Academy of Health Sciences Nepal 8) Kanti Childrens Hospital Nepal 9) Kalawati Saran Children�s hospital New Delhi

Secondary Sponsor(s)

Institute of Medicine Tribhuvan University

Ethics review

Status: Approved
Approval date: 11/07/2016
Contact:

V.M.M.C and Safdarjung Hospital, Institute Ethics Committee

Status: Approved
Approval date: 02/08/2016
Contact:

North Delhi Kasturba Hospital, Ethics Committee

Status: Approved
Approval date: 15/12/2016
Contact:

Maulana Azad Medical College and Associated Hospital, Institutional Ethics Committee

Status: Approved
Approval date: 15/12/2016
Contact:

Maulana Azad Medical College and Associated Hospital, Institutional Ethics Committee for Chacha Nehru Bal Chikitsalaya

Status: Approved
Approval date: 13/04/2019
Contact:

Ethics Committee for Human Research, Lady Hardinge Medical College & Associated Hospitals