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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06102044
Other study ID # IRB23-0138
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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