Global Genomic and Proteomic Profiling of African Children With Typhoid Fever

NCT02947295 | Completed

• 1 other identifier: 0445-12 EP
• Study Type: observational
• Target: 969
• Locations: 1 country
• Sites: 1

Brief Summary

To develop a rapid, sensitive, and inexpensive diagnostic method, as well as more efficacious vaccine, for countries where typhoid fever remains a major public health burden.

Conditions

Typhoid Fever

Outcome Measures

Primary Outcomes (3)

• Typhoid fever-specific host response classifier genes

  Define typhoid fever-specific host response classifier genes using gene expression (GE) micro-arrays.

  10 years

• Serum anti-typhoid fever proteins

  Discover specific serum anti-typhoid fever proteins using newly established S. Typhi proteome micro-arrays and develop prototype serologic assay for acute typhoid (ELISA)

  10 years

• Validate classifier genes and field-test prototype ELISAs

  Validate classifier genes and field-test prototype ELISAs using new, independent cohorts.

  10 years

Eligibility Criteria

• Age: 1 Minute - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children 1-14 years old who present with an acute febrile illness that is clinically suggestive of bacteremia.

You may qualify if:

• Children ages 1-14 years who present with an acute febrile illness that is clinically suggestive of bacteremia.

You may not qualify if:

• Children who have underlying conditions that are recognized to increase susceptibility to invasive salmonellosis. Other conditions that are associated with frequent opportunistic infections that may cause aberrations of immune function will also be excluded, such as human immunodeficiency virus (HIV) infection and malnutrition. Clinical conditions that are known to be associated with increased risk of salmonella carriage will also be excluded, such as schistosomiasis.

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

National Hospital of Nigeria

Abuja, Nigeria

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, stool, nasopharyngeal swab/aspirate as well as cerebrospinal fluid (CSF), pleural fluid, induced sputum, gastric aspirates or synovial fluid with clinical indication.

MeSH Terms

Conditions

Typhoid Fever

Condition Hierarchy (Ancestors)

Salmonella Infections; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Stephen K Obaro, MD

  Univeristy of Nebraska Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2014
• First Posted: October 27, 2016
• Study Start: September 13, 2012
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: September 29, 2023

Record last verified: 2023-09

Locations

NG (1)