Suplementação de zinco para bebês com infecção clínica grave na Tanzânia
Ensaio de suplementos de zinco para bebês com infecção clínica grave na Tanzânia
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 3
Contactos e Locais
Contato de estudo
- Nome: Christopher R Sudfeld, ScD
- Número de telefone: (617) 432-5051
- E-mail: csudfeld@hsph.harvard.edu
Locais de estudo
-
-
-
Dar es Salaam, Tanzânia
- Recrutamento
- Muhimbili University of Health and Allied Sciences
-
Contato:
- Karim P Manji, MD
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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 |
|
Comparador de Placebo: Placebo
14-day regimen of twice-daily oral placebo supplements to be taken orally or by enteral feeding tube |
Dispersible placebo tablets |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Death
Prazo: 90 Days
|
All-cause infant death |
90 Days
|
|
Treatment Failure
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Death during initial hospitalization
Prazo: 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
Prazo: Randomization to Day 90
|
Hours from randomization to initial hospitalization discharge |
Randomization to Day 90
|
|
Duration of signs of clinical severe infection
Prazo: 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
Prazo: 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
Prazo: Randomization to Day 15
|
Vomiting observed by study staff within 30 minutes of regimen dosing |
Randomization to Day 15
|
|
Re-hospitalization
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Day 15
|
Infant length-for-age z-score by WHO Child Growth Standards |
Day 15
|
|
Infant length-for-age z-score at Day 90
Prazo: Day 90
|
Infant length-for-age z-score by WHO Child Growth Standards |
Day 90
|
|
Infant weight-for-age z-score at Day 15
Prazo: Day 15
|
Infant weight-for-age z-score by WHO Child Growth Standards |
Day 15
|
|
Infant weight-for-age z-score at Day 90
Prazo: Day 90
|
Infant weight-for-age z-score by WHO Child Growth Standards |
Day 90
|
|
Infant weight-for-length z-score at Day 15
Prazo: Day 15
|
Infant weight-for-length z-score by WHO Child Growth Standards |
Day 15
|
|
Infant weight-for-length z-score at Day 90
Prazo: Day 90
|
Infant weight-for-length z-score by WHO Child Growth Standard |
Day 90
|
|
Plasma zinc concentrations at Day 15
Prazo: Day 15
|
Infant plasma zinc concentration |
Day 15
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Christopher R Sudfeld, ScD, Harvard School of Public Health (HSPH)
- Investigador principal: Christopher P Duggan, MD, Harvard School of Public Health (HSPH) and Boston Children's Hospital
- Investigador principal: Karim P Manji, MD, Muhimbili University of Health and Allied Sciences
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- IRB23-0138
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