Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania

Phase

Condition

N/A

Treatment

Zinc Supplements

Placebo Supplements

Clinical Study ID

NCT06102044

IRB23-0138

Ages < 59
All Genders

Study 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

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

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 Design