Clinical trial NCT06102044: Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania
Official title: Trial of Zinc Supplements for Young Infants With Clinical Severe Infection in Tanzania
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Neonatal Infection
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: Muhimbili University of Health and Allied Sciences
First posted: 2023-10-26
Enrollment: 3250
Sex: ALL
Minimum age (years): 0
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Bacterial infections among young infants, including sepsis, meningitis, and pneumonia, continue to cause a substantial number of deaths globally. Zinc supplementation in combination with standard antibiotic therapy may represent a new intervention to reduce mortality and improve treatment outcomes for young infants with clinical severe infection.

The Investigators will conduct a randomized, double-blind, placebo-controlled trial of zinc supplementation among young infants 0-59 days with severe clinical infection. The trial will enroll 3,250 Tanzanian infants hospitalized with clinical severe infection as defined by WHO Integrated Management of Childhood Illness (IMCI) guidelines. Enrolled infants will receive standard clinical management including antibiotics and will be randomized to receive either a 14-day course of twice-daily 5 mg elemental zinc (10 mg per day) or a matching placebo regimen.


Eligibility criteria: Inclusion Criteria:

* Young infants aged 0-59 days
* Diagnosis of clinical severe infection (CSI)
* Ability to feed enterally
* Intend to stay in the study area for 90 days
* Provided informed consent

Exclusion Criteria:

* Prior use of zinc supplements during the current illness
* Receipt of antibiotics for \>24 hours before enrollment
* Diarrhea at enrollment
* Signs suggestive of serious illness/condition that is not clinical severe infection
* Previously enrolled in the trial
* Enrolled in other research study

Primary outcomes:
measure: Death
timeFrame: 90 Days
measure: Treatment Failure
timeFrame: From date of randomization until the date of first documented treatment failure or date of death from any cause during the initial hospitalization, whichever comes first, assessed up to 90 days
Secondary outcomes:
measure: Death during initial hospitalization
timeFrame: Randomization to the date of initial hospitalization discharge, assessed up to 90 days
measure: Duration of initial hospital stay
timeFrame: Randomization to Day 90
measure: Duration of signs of clinical severe infection
timeFrame: Randomization to Day 90
measure: Diarrhea during initial hospital admission
timeFrame: Randomization to the date of initial hospitalization discharge, assessed up to 90 days
measure: Rate of vomiting related to regimen dosing
timeFrame: Randomization to Day 15
measure: Re-hospitalization
timeFrame: Date of initial hospitalization discharge to Day 90
measure: Presence of any sign of possible severe bacterial infection at Day 15
timeFrame: Day 15
measure: Presence of any sign of possible severe bacterial infection at Day 90
timeFrame: Day 90
measure: Proportion of Children with Diarrhea at Day 15 or Day 90
timeFrame: Day 15 and Day 90
measure: Infant length-for-age z-score at Day 15
timeFrame: Day 15
measure: Infant length-for-age z-score at Day 90
timeFrame: Day 90
measure: Infant weight-for-age z-score at Day 15
timeFrame: Day 15
measure: Infant weight-for-age z-score at Day 90
timeFrame: Day 90
measure: Infant weight-for-length z-score at Day 15
timeFrame: Day 15
measure: Infant weight-for-length z-score at Day 90
timeFrame: Day 90
measure: Plasma zinc concentrations at Day 15
timeFrame: Day 15
Other outcomes:
Locations:
city: Dar Es Salaam
country: Tanzania
facility: Muhimbili University of Health and Allied Sciences
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Christopher R Sudfeld, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard School of Public Health (HSPH) and Boston Children's Hospital
name: Christopher P Duggan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Muhimbili University of Health and Allied Sciences
name: Karim P Manji, MD
role: PRINCIPAL_INVESTIGATOR
References: