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
Conditions
Interventions
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:
Sponsors
Translational Health Science and Technology Institute
Institute of Medicine Tribhuvan University
Eligibility
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 ;Health gain, financial risk protection and cost effectiveness analysisTimepoint: Enrollment to end of study period (until 12 weeks from day of enrollment);Immunobiological readouts to evaluate effect of zincTimepoint: 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 ;Stool for enteropathogens and characterization of intestinal microbiome/metagenomeTimepoint: Enrolment - V1 | — |
Countries
India, Nepal
Contacts
Public ContactDr Shinjini Bhatnagar
Translational Health Science and Technology Institute
Outcome results
None listed