Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania

Neonatal Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06102044
• Other study ID #: IRB23-0138
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 30, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: April 2024
• Source: Harvard School of Public Health (HSPH)
• Contact: Christopher R Sudfeld, ScD
• Phone: (617) 432-5051
• Email: csudfeld[@]hsph.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3250
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 59 Days

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Neonatal Infection

Intervention

Dietary Supplement:
• Zinc Supplements
Dispersible zinc sulfate tablets
• Placebo Supplements
Dispersible placebo tablets

Locations

Country	Name	City	State
Tanzania	Muhimbili University of Health and Allied Sciences	Dar Es Salaam

Sponsors (2)

Lead Sponsor	Collaborator
Harvard School of Public Health (HSPH)	Muhimbili University of Health and Allied Sciences

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death	All-cause infant death	90 Days
Primary	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