Infections are the important cause of high mortality in young infants in developing
countries. Zinc is a crucial micronutrient as it influences various immune mechanisms and
modulates host resistance to several pathogens. It has shown benefits as an adjunct therapy
in infections like diarrhea and pneumonia in older children Given the predisposition of young
infants in developing countries to zinc deficiency and infections, addition of zinc to
standard treatment of serious bacterial infections may lead to significant improvements in
the outcomes.
Several hypotheses will be examined in this clinical trial. The primary objective is to
measure, in a double blind randomized controlled trial, the efficacy of giving 2 RDA
(Required Daily Allowance 10 mg) of zinc orally in addition to routine antibiotics, for
treatment of possible serious bacterial infection in infants >= 7 days and up to 4 months of
age in reducing the proportion of treatment failures and time to discharge from the hospital.
This will evaluate the clinical consequences of the possible immunomodulation by zinc
supplementation. This is critical to demonstrate because nearly 80% of infant mortality
occurs in first months of life.
Young infants with possible serious bacterial infections fulfilling the inclusion criteria
will be enrolled in the study and stratified into 4 groups on basis of weight for age 'z'
scores < -2 z and >=- 2 z and whether he/she has diarrhea or not. Within each stratum the
subjects will be randomized to receive zinc or placebo. Treatment failures will be defined by
the need for a change of initial antibiotic therapy. The minimum duration of monitoring will
be till clinical recovery (using predetermined criteria). Serum copper, serum ferritin and
serum transferrin receptors will be determined at enrollment, 72 hours after enrollment and
at discharge from the hospital. Concentrations of CRP and procalcitonin will be measured at
baseline, 72 hours after enrolment and at clinical recovery.
Documentation of efficacy of addition of zinc to standard therapy may provide a simple and
low-cost strategy to improve survival in serious infections in young infants. This is likely
to have a significant impact on infant morbidity and mortality. It will be good example of
using a simple immunomodulator beneficially in improving child health.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Centre For International Health
Collaborator:
All India Institute of Medical Sciences, New Delhi