Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Death [90 Days]
All-cause infant death
- Treatment Failure [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]
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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Muhimbili University of Health and Allied Sciences | Dar Es Salaam | Tanzania |
Sponsors and Collaborators
- Harvard School of Public Health (HSPH)
- 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB23-0138