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Sinktilskudd for små spedbarn med klinisk alvorlig infeksjon i Tanzania

5. november 2026 oppdatert av: Christopher Robert Sudfeld, Harvard School of Public Health (HSPH)

Utprøving av sinktilskudd for små spedbarn med klinisk alvorlig infeksjon 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

3250

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Tanzania
      • Dar es Salaam, Tanzania
        • Rekruttering
        • Muhimbili University of Health and Allied Sciences
        • Ta kontakt med:
          • Karim P Manji, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

1 sekund til 1 måned (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Zinc Supplementation

14-day regimen of twice-daily 5 mg elemental zinc supplements to be taken orally or by enteral feeding tube
Kosttilskudd: Zinc Supplements

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
Kosttilskudd: Placebo Supplements

Dispersible placebo tablets

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Harvard School of Public Health (HSPH)

Samarbeidspartnere

Muhimbili University of Health and Allied Sciences

Etterforskere

  • Hovedetterforsker: Christopher R Sudfeld, ScD, Harvard School of Public Health (HSPH)
  • Hovedetterforsker: Christopher P Duggan, MD, Harvard School of Public Health (HSPH) and Boston Children's Hospital
  • Hovedetterforsker: Karim P Manji, MD, Muhimbili University of Health and Allied Sciences

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

27. desember 2024

Primær fullføring (Antatt)

1. januar 2028

Studiet fullført (Antatt)

1. januar 2028

Datoer for studieregistrering

Først innsendt

20. oktober 2023

Først innsendt som oppfylte QC-kriteriene

25. oktober 2023

Først lagt ut (Faktiske)

26. oktober 2023

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • IRB23-0138

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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