Zinktilskud til små spædbørn med klinisk alvorlig infektion i Tanzania
Forsøg med zinktilskud til små spædbørn med klinisk alvorlig infektion i 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
- Navn: Christopher R Sudfeld, ScD
- Telefonnummer: (617) 432-5051
- E-mail: csudfeld@hsph.harvard.edu
Studiesteder
-
-
-
Dar es Salaam, Tanzania
- Rekruttering
- Muhimbili University of Health and Allied Sciences
-
Kontakt:
- Karim P Manji, MD
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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 komparator: Placebo
14-day regimen of twice-daily oral placebo supplements to be taken orally or by enteral feeding tube |
Dispersible placebo tablets |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Death
Tidsramme: 90 Days
|
All-cause infant death |
90 Days
|
|
Treatment Failure
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Death during initial hospitalization
Tidsramme: 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
Tidsramme: Randomization to Day 90
|
Hours from randomization to initial hospitalization discharge |
Randomization to Day 90
|
|
Duration of signs of clinical severe infection
Tidsramme: 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
Tidsramme: 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
Tidsramme: Randomization to Day 15
|
Vomiting observed by study staff within 30 minutes of regimen dosing |
Randomization to Day 15
|
|
Re-hospitalization
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Day 15
|
Infant length-for-age z-score by WHO Child Growth Standards |
Day 15
|
|
Infant length-for-age z-score at Day 90
Tidsramme: Day 90
|
Infant length-for-age z-score by WHO Child Growth Standards |
Day 90
|
|
Infant weight-for-age z-score at Day 15
Tidsramme: Day 15
|
Infant weight-for-age z-score by WHO Child Growth Standards |
Day 15
|
|
Infant weight-for-age z-score at Day 90
Tidsramme: Day 90
|
Infant weight-for-age z-score by WHO Child Growth Standards |
Day 90
|
|
Infant weight-for-length z-score at Day 15
Tidsramme: Day 15
|
Infant weight-for-length z-score by WHO Child Growth Standards |
Day 15
|
|
Infant weight-for-length z-score at Day 90
Tidsramme: Day 90
|
Infant weight-for-length z-score by WHO Child Growth Standard |
Day 90
|
|
Plasma zinc concentrations at Day 15
Tidsramme: Day 15
|
Infant plasma zinc concentration |
Day 15
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Christopher R Sudfeld, ScD, Harvard School of Public Health (HSPH)
- Ledende efterforsker: Christopher P Duggan, MD, Harvard School of Public Health (HSPH) and Boston Children's Hospital
- Ledende efterforsker: Karim P Manji, MD, Muhimbili University of Health and Allied Sciences
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- IRB23-0138
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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