Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania
ConditionNeonatal Infection
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age0-59
SponsorHarvard School of Public Health (HSPH)
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Zinc Supplements
Dietary supplementDispersible zinc citrate tablets
Placebo Supplements
Dietary supplementDispersible placebo tablets
Treatment groups
3,250 Participants
are divided into 2 treatment groupsGroup A: Zinc SupplementationExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Death
All-cause infant death
Time frame
90 Days2
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
Time frame
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 daysSecondary outcomes
1
Death during initial hospitalization
All-cause mortality during initial hospitalization
Time frame
Randomization to the date of initial hospitalization discharge, assessed up to 90 days2
Duration of initial hospital stay
Hours from randomization to initial hospitalization discharge
Time frame
Randomization to Day 903
Duration of signs of clinical severe infection
Hours from randomization to the absence of any sign of clinical severe infection
Time frame
Randomization to Day 904
Diarrhea during initial hospital admission
Clinical diagnosis based on three or more loose or watery stools in the past 24 hours
Time frame
Randomization to the date of initial hospitalization discharge, assessed up to 90 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Harvard School of Public Health (HSPH)
Lead sponsor
Muhimbili University of Health and Allied Sciences
Collaborator
Source ClinicalTrials.gov