Zinksuppletie voor jonge baby's met een klinisch ernstige infectie in Tanzania
Proef met zinksupplementen voor jonge kinderen met een klinisch ernstige infectie in Tanzania
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Fase 3
Contacten en locaties
Studiecontact
- Naam: Christopher R Sudfeld, ScD
- Telefoonnummer: (617) 432-5051
- E-mail: csudfeld@hsph.harvard.edu
Studie Locaties
-
-
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Dar es Salaam, Tanzania
- Werving
- Muhimbili University of Health and Allied Sciences
-
Contact:
- Karim P Manji, MD
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-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Zinc Supplementation
14-day regimen of twice-daily 5 mg elemental zinc supplements to be taken orally or by enteral feeding tube |
Dispersible zinc citrate tablets |
|
Placebo-vergelijker: Placebo
14-day regimen of twice-daily oral placebo supplements to be taken orally or by enteral feeding tube |
Dispersible placebo tablets |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Death
Tijdsspanne: 90 Days
|
All-cause infant death |
90 Days
|
|
Treatment Failure
Tijdsspanne: 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 |
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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Death during initial hospitalization
Tijdsspanne: Randomization to the date of initial hospitalization discharge, assessed up to 90 days
|
All-cause mortality during initial hospitalization |
Randomization to the date of initial hospitalization discharge, assessed up to 90 days
|
|
Duration of initial hospital stay
Tijdsspanne: Randomization to Day 90
|
Hours from randomization to initial hospitalization discharge |
Randomization to Day 90
|
|
Duration of signs of clinical severe infection
Tijdsspanne: Randomization to Day 90
|
Hours from randomization to the absence of any sign of clinical severe infection |
Randomization to Day 90
|
|
Diarrhea during initial hospital admission
Tijdsspanne: Randomization to the date of initial hospitalization discharge, assessed up to 90 days
|
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
Tijdsspanne: Randomization to Day 15
|
Vomiting observed by study staff within 30 minutes of regimen dosing |
Randomization to Day 15
|
|
Re-hospitalization
Tijdsspanne: Date of initial hospitalization discharge to Day 90
|
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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Day 15 and 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
Tijdsspanne: Day 15
|
Infant length-for-age z-score by WHO Child Growth Standards |
Day 15
|
|
Infant length-for-age z-score at Day 90
Tijdsspanne: Day 90
|
Infant length-for-age z-score by WHO Child Growth Standards |
Day 90
|
|
Infant weight-for-age z-score at Day 15
Tijdsspanne: Day 15
|
Infant weight-for-age z-score by WHO Child Growth Standards |
Day 15
|
|
Infant weight-for-age z-score at Day 90
Tijdsspanne: Day 90
|
Infant weight-for-age z-score by WHO Child Growth Standards |
Day 90
|
|
Infant weight-for-length z-score at Day 15
Tijdsspanne: Day 15
|
Infant weight-for-length z-score by WHO Child Growth Standards |
Day 15
|
|
Infant weight-for-length z-score at Day 90
Tijdsspanne: Day 90
|
Infant weight-for-length z-score by WHO Child Growth Standard |
Day 90
|
|
Plasma zinc concentrations at Day 15
Tijdsspanne: Day 15
|
Infant plasma zinc concentration |
Day 15
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Christopher R Sudfeld, ScD, Harvard School of Public Health (HSPH)
- Hoofdonderzoeker: Christopher P Duggan, MD, Harvard School of Public Health (HSPH) and Boston Children's Hospital
- Hoofdonderzoeker: Karim P Manji, MD, Muhimbili University of Health and Allied Sciences
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- IRB23-0138
Plan Individuele Deelnemersgegevens (IPD)
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Informatie over medicijnen en apparaten, studiedocumenten
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