Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Muhimbili University of Health and Allied Sciences | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zinc Supplementation | Experimental | 14-day regimen of twice-daily 5 mg elemental zinc supplements to be taken orally or by enteral feeding tube |
|
| Placebo | Placebo Comparator | 14-day regimen of twice-daily oral placebo supplements to be taken orally or by enteral feeding tube |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zinc Supplements | Dietary Supplement | Dispersible zinc citrate tablets |
| |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Death during initial hospitalization | All-cause mortality during initial hospitalization | Randomization to the date of initial hospitalization discharge, assessed up to 90 days |
| Duration of initial hospital stay |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christopher R Sudfeld, ScD | Contact | (617) 432-5051 | csudfeld@hsph.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Muhimbili University of Health and Allied Sciences | Recruiting | Dar es Salaam | Tanzania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40813142 | Background | Manji KP, Somji S, Bakari M, Fawzi WW, Kibwana U, Kisenge R, Kisumuni AS, Liu E, Mafie N, Maleko FA, Salim N, Duggan CP, Sudfeld CR. Efficacy of zinc supplementation for young infants with clinical severe infection in Tanzania: study protocol for a randomised controlled trial. BMJ Paediatr Open. 2025 Aug 14;9(1):e003804. doi: 10.1136/bmjpo-2025-003804. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo Supplements |
| Dietary Supplement |
Dispersible placebo tablets |
|
Hours from randomization to initial hospitalization discharge
| Randomization to Day 90 |
| Duration of signs of clinical severe infection | Hours from randomization to the absence of any sign of clinical severe infection | Randomization to Day 90 |
| Diarrhea during initial hospital admission | Clinical diagnosis based on three or more loose or watery stools in the past 24 hours | Randomization to the date of initial hospitalization discharge, assessed up to 90 days |
| Rate of vomiting related to regimen dosing | Vomiting observed by study staff within 30 minutes of regimen dosing | Randomization to Day 15 |
| Re-hospitalization | Infant admitted and stayed overnight in health facility after being discharged from initial hospitalization | Date of initial hospitalization discharge to Day 90 |
| Presence of any sign of possible severe bacterial infection at Day 15 | Presence of a clinical sign of possible severe bacterial infection, including: high body temperature ≥38°C, low body temperature <35.5°C , severe chest indrawing, movement only on stimulation or no movement at all, stopped feeding well or unable to feed at all, or convulsions. | Day 15 |
| Presence of any sign of possible severe bacterial infection at Day 90 | Presence of a clinical sign of possible severe bacterial infection, including: high body temperature ≥38°C, low body temperature <35.5°C , severe chest indrawing, movement only on stimulation or no movement at all, stopped feeding well or unable to feed at all, or convulsions. | Day 90 |
| Proportion of Children with Diarrhea at Day 15 or Day 90 | Maternal report of three or more loose or watery stools in the past 24 hours | Day 15 and Day 90 |
| Infant length-for-age z-score at Day 15 | Infant length-for-age z-score by WHO Child Growth Standards | Day 15 |
| Infant length-for-age z-score at Day 90 | Infant length-for-age z-score by WHO Child Growth Standards | Day 90 |
| Infant weight-for-age z-score at Day 15 | Infant weight-for-age z-score by WHO Child Growth Standards | Day 15 |
| Infant weight-for-age z-score at Day 90 | Infant weight-for-age z-score by WHO Child Growth Standards | Day 90 |
| Infant weight-for-length z-score at Day 15 | Infant weight-for-length z-score by WHO Child Growth Standards | Day 15 |
| Infant weight-for-length z-score at Day 90 | Infant weight-for-length z-score by WHO Child Growth Standard | Day 90 |
| Plasma zinc concentrations at Day 15 | Infant plasma zinc concentration | Day 15 |
| Karim P Manji, MD | Muhimbili University of Health and Allied Sciences | Principal Investigator |