Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania

Trial of Zinc Supplements for Young Infants With Clinical Severe Infection in Tanzania

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neonatal Infection
• Intervention / Treatment: Dietary supplement: Zinc Supplements; Dietary supplement: Placebo Supplements

• Study Type: Interventional
• Enrollment (Estimated): 3250
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Christopher R Sudfeld, ScD; Phone Number: (617) 432-5051; Email: csudfeld@hsph.harvard.edu

Study Locations

• Tanzania
  • Dar Es Salaam, Tanzania
    • Muhimbili University of Health and Allied Sciences
    • Contact: Karim P Manji, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Zinc Supplementation; 14-day regimen of twice-daily 5 mg elemental zinc supplements to be taken orally or by enteral feeding tube	Dietary supplement: Zinc Supplements; Dispersible zinc sulfate tablets
Placebo Comparator: Placebo; 14-day regimen of twice-daily oral placebo supplements to be taken orally or by enteral feeding tube	Dietary supplement: Placebo Supplements; Dispersible placebo tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	All-cause infant death	90 Days
Treatment Failure	A composite endpoint of death during initial period of hospitalization, the need for additional respiratory support (either mechanical ventilation, or positive end expiratory pressure support) or the use of vasoactive medicines to support blood pressure or need to change antibiotics during the initial hospitalization	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

Collaborators and Investigators

• Sponsor: Harvard School of Public Health (HSPH)
• Collaborators: Muhimbili University of Health and Allied Sciences
• Investigators: Principal Investigator: Christopher R Sudfeld, ScD, Harvard School of Public Health (HSPH); Principal Investigator: Christopher P Duggan, MD, Harvard School of Public Health (HSPH) and Boston Children's Hospital; Principal Investigator: Karim P Manji, MD, Muhimbili University of Health and Allied Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: October 20, 2023
• First Submitted That Met QC Criteria: October 25, 2023
• First Posted (Actual): October 26, 2023

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: IRB23-0138

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No