Supplémentation en zinc pour les jeunes nourrissons atteints d'une infection clinique grave en Tanzanie
Essai de suppléments de zinc pour les jeunes nourrissons atteints d'une infection clinique grave en Tanzanie
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- Phase 3
Contacts et emplacements
Coordonnées de l'étude
- Nom: Christopher R Sudfeld, ScD
- Numéro de téléphone: (617) 432-5051
- E-mail: csudfeld@hsph.harvard.edu
Lieux d'étude
-
-
-
Dar es Salaam, Tanzanie
- Recrutement
- Muhimbili University of Health and Allied Sciences
-
Contact:
- Karim P Manji, MD
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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 |
|
Comparateur placebo: Placebo
14-day regimen of twice-daily oral placebo supplements to be taken orally or by enteral feeding tube |
Dispersible placebo tablets |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Death
Délai: 90 Days
|
All-cause infant death |
90 Days
|
|
Treatment Failure
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Death during initial hospitalization
Délai: 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
Délai: Randomization to Day 90
|
Hours from randomization to initial hospitalization discharge |
Randomization to Day 90
|
|
Duration of signs of clinical severe infection
Délai: 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
Délai: 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
Délai: Randomization to Day 15
|
Vomiting observed by study staff within 30 minutes of regimen dosing |
Randomization to Day 15
|
|
Re-hospitalization
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Day 15
|
Infant length-for-age z-score by WHO Child Growth Standards |
Day 15
|
|
Infant length-for-age z-score at Day 90
Délai: Day 90
|
Infant length-for-age z-score by WHO Child Growth Standards |
Day 90
|
|
Infant weight-for-age z-score at Day 15
Délai: Day 15
|
Infant weight-for-age z-score by WHO Child Growth Standards |
Day 15
|
|
Infant weight-for-age z-score at Day 90
Délai: Day 90
|
Infant weight-for-age z-score by WHO Child Growth Standards |
Day 90
|
|
Infant weight-for-length z-score at Day 15
Délai: Day 15
|
Infant weight-for-length z-score by WHO Child Growth Standards |
Day 15
|
|
Infant weight-for-length z-score at Day 90
Délai: Day 90
|
Infant weight-for-length z-score by WHO Child Growth Standard |
Day 90
|
|
Plasma zinc concentrations at Day 15
Délai: Day 15
|
Infant plasma zinc concentration |
Day 15
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Christopher R Sudfeld, ScD, Harvard School of Public Health (HSPH)
- Chercheur principal: Christopher P Duggan, MD, Harvard School of Public Health (HSPH) and Boston Children's Hospital
- Chercheur principal: Karim P Manji, MD, Muhimbili University of Health and Allied Sciences
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- IRB23-0138
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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