Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04838587
Status:
COMPLETED
Last Update Posted:
2022-07-20
First Post:
2021-02-05
Brief Title:
An Epidemiological Surveillance Study to Determine the Incidence of ETEC in Children and Infants in Lusaka
Sponsor:
Centre for Infectious Disease Research in Zambia
Organization:
Centre for Infectious Disease Research in Zambia
Study Overview
Official Title:
An Epidemiological Surveillance Study to Determine the Incidence of ETEC in Children and Infants in Lusaka
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ETEC-Surv
Brief Summary:
Diarrhoea is the one of the top five leading causes of death among children below the age of five years globally It is estimated that one in ten deaths in children under five is attributed to diarrhoea Enterotoxigenic Ecoli ETEC is one of the major causative agents of moderate-to-severe MSD diarrhoea among children both globally and in Zambia
The overall aim of this study is to document the burden of ETEC associated diarrhoea in Zambian children under 3 years of age
The overall aim of this study is to document the burden of ETEC associated diarrhoea in Zambian children under 3 years of age
Detailed Description:
This study seeks to determine diarrhoea aetiology calculate the incidence of moderate-to-severe ETEC-associated diarrhea and describe the frequency of ETEC colonization factors and enterotoxin types in children under 3 years old in Zambia
These data are required for the design of an anticipated phase 3 trial of the leading ETEC vaccine ETVAX that will be evaluated in Zambia from 2021 onwards
The following are the research questions that this study seeks to answer
1 What is the incidence of MSD with confirmed ETEC aetiology in children under three years old in Zambia
2 What are the prevalent colonization toxins and factors CFs in diarrhoeagenic isolates of ETEC infections in children in Zambia
3 What are the other common pathogens causing diarrhoea in Zambian children
This prospective observational longitudinal study is proposed at five health facilities in Lusaka The proposed study sites are Chawama George Kanyama Chainda and Matero Health Facilities These facilities are located within typical peri-urban settlements of Lusaka and serves communities with a cumulative total population of over 1 million people The study will be done in two stages beginning with a household census in the study catchment area of the participating health facilities and then followed by the passive diarrhoea surveillance stage A surveillance system for passive case detection of diarrhoea will be set up at each facility for the 12-months of the project to detect any seasonal variations of disease burden Prior to commencement several community sensitization activities will be conducted within the catchment areas of the health facility
A stool sample will be collected from each participant who presents to the health facility and is eligible for enrollment All research samples will be collected at the study site and laboratory assays will be performed as per written SOPs and will be a part of the study documentation All the samples will be processed in Zambia using the Novodiag platform The Novodiag Mobidiag Ltd Finland is a novel multiplex molecular platform that is based on real-time PCR and microarray technology and can identify various gastroenteritis causing bacteria parasites and viruses as well as carry out antimicrobial resistance gene testing of organisms
These data are required for the design of an anticipated phase 3 trial of the leading ETEC vaccine ETVAX that will be evaluated in Zambia from 2021 onwards
The following are the research questions that this study seeks to answer
1 What is the incidence of MSD with confirmed ETEC aetiology in children under three years old in Zambia
2 What are the prevalent colonization toxins and factors CFs in diarrhoeagenic isolates of ETEC infections in children in Zambia
3 What are the other common pathogens causing diarrhoea in Zambian children
This prospective observational longitudinal study is proposed at five health facilities in Lusaka The proposed study sites are Chawama George Kanyama Chainda and Matero Health Facilities These facilities are located within typical peri-urban settlements of Lusaka and serves communities with a cumulative total population of over 1 million people The study will be done in two stages beginning with a household census in the study catchment area of the participating health facilities and then followed by the passive diarrhoea surveillance stage A surveillance system for passive case detection of diarrhoea will be set up at each facility for the 12-months of the project to detect any seasonal variations of disease burden Prior to commencement several community sensitization activities will be conducted within the catchment areas of the health facility
A stool sample will be collected from each participant who presents to the health facility and is eligible for enrollment All research samples will be collected at the study site and laboratory assays will be performed as per written SOPs and will be a part of the study documentation All the samples will be processed in Zambia using the Novodiag platform The Novodiag Mobidiag Ltd Finland is a novel multiplex molecular platform that is based on real-time PCR and microarray technology and can identify various gastroenteritis causing bacteria parasites and viruses as well as carry out antimicrobial resistance gene testing of organisms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None