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Typhoid Fever clinical trials

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NCT ID: NCT05579821 Completed - Typhoid Fever Clinical Trials

Evaluation Study of DPP® Typhoid Assay

Start date: September 15, 2022
Phase:
Study type: Observational

Fever management is a major problem in Low and Middle Income Countries (LMICs) where access to good quality diagnostic test is often unavailable. Fever due to typhoid is similar to other undifferentiated febrile illnesses and typhoid can be mistaken with other vector borne febrile illnesses such as scrub typhus. Currently available diagnostic tests, blood and bone marrow culture, and RDTs have several limitations including a low sensitivity and specificity . Recently, several antigens of Salmonella Typhi useful for serodiagnosis of typhoid has been identified. Salmonella Typhi lipopolysaccharide (LPS) and hemolysin E (HlyE) have been identified as top candidate antigens by several studies to differentiate acute typhoid patients from healthy individuals. DPP® Typhoid Assay is a multiplex rapid test that detects IgA antibodies to LPS and HlyE antigen. It is considered to have high sensitivity and specificity and its results were found to be highly correlated with ELISA results. However, very few studies have been conducted to evaluate this test and limited information about the accuracy of this test is present. Hence, this study will evaluate the sensitivity and specificity of this test in archived serum sample of well characterized blood culture positives and negatives in support of new innovation on typhoid diagnostics.

NCT ID: NCT04830371 Completed - Typhoid Fever Clinical Trials

Non-inferiority and Safety Study of EuTCV Compared to Typbar-TCV in Healthy 6 Months-45 Years Aged Participants

Start date: September 7, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

This is an observer-blinded, comparative, single dose, clinical phase II/III study to assess the immunogenicity and safety of EuTCV compared to Typhoid conjugate vaccine in healthy Filipino participants aged 6 months to 45 years.

NCT ID: NCT04801602 Completed - Typhoid Fever Clinical Trials

Commercial Typhoid Tests Validation Trial

Start date: October 25, 2020
Phase:
Study type: Observational

Typhoid fever (typhoid) is an enteric bacterial infection caused by Salmonella enterica serovar Typhi (Salmonella Typhi; S. Typhi). It is one of the most common bacterial causes of acute febrile illness in the developing world, with an estimated 10.9 million new cases worldwide and 116.8 thousand deaths in 2017. Like many febrile illnesses, typhoid presents with non-specific symptoms and signs, especially in its early stages. In routine healthcare settings in low- and middle-income countries (LMIC), typhoid fever is commonly suspected and treated empirically with antibiotics. This overuse of antibiotics creates a selective pressure for the development of antimicrobial resistance (AMR), that has resulted in the emergence and spread of typhoid strains that are resistant to all first-line antibiotics. Similarly, the low specificity of current rapid diagnostic tests (RDTs) can lead to an over diagnosis of typhoid fever that may result in the overuse of antibiotics and delay the proper treatment for underlying conditions. FIND in collaboration with international typhoid experts developed a target product profile outlining the ideal characteristics of point of care tests. As part of this activity it became apparent that no quality data are available that systematically compare all available commercially point of care tests against the same set of reference standards used in multiple populations (e.g. Africa vs Asia). This lack of benchmarking data significantly impedes health provider's ability to decide on the utility of commercial tests in different settings, ultimately restricting use and access. Further the lack of well characterized samples reduces the ability for targeted innovation in the typhoid space. The current study aims to benchmark different commercial typhoid tests against a defined reference standard applied in multiple population and simultaneously develop a sample set that can be used in future evaluations of emerging technologies and/or to support innovative test development.

NCT ID: NCT04349553 Completed - Enteric Fever Clinical Trials

Study to Evaluate the Safety, Tolerability and Immunogenicity of a Potential Enteric Fever Vaccine

Start date: December 16, 2019
Phase: Phase 1
Study type: Interventional

A Phase 1, randomised, double-blind, placebo-controlled, parallel group study in 45 healthy participants aged 18 to 45 years inclusive.

NCT ID: NCT04204096 Completed - Typhoid Clinical Trials

Immune Equivalence Between Multi-dose and Single Dose Formulation of Vi-DT and Their Overall Safety (Phase III)

Start date: February 4, 2020
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, observer-blinded, controlled, immune equivalence study of a multi-dose (MD) formulation with 2PE preservative of SK bioscience Vi-DT compared to single dose (SD) formulation without preservative of SK bioscience Vi-DT in participant (6 months - 45 years) including safety population. The study objectives are as follows: - Primary objective. Demonstrate the immune equivalence as measured by anti-Vi IgG Geometric Mean Titer (GMT) of multi dose formulation against single dose formulation of Vi-DT (18-45 year age stratum), at 4 weeks after a single dose. - Secondary objective 1. Demonstrate the immune equivalence as measured by seroconversion rates of anti-Vi IgG antibody titres of multi dose formulation against single dose formulation of Vi-DT vaccine (18-45 year age stratum) at 4 weeks after a single dose. - Secondary objective 2. Describe safety profile in all age strata combined (age 6 months - 45 years old) and in each age stratum, at 4 weeks after a single dose of SD/MD formulation/control (Meningococcal Conjugate Vaccine). There are total 5 scheduled visits as follows: - Visit 1(D-7 to 0): Screening - Visit 2(D0): Enrollment, vaccination, safety follow-up and blood collection for immunogenicity assessment (only for subjects 18 years old and above) - Visit 3(D7): Safety follow-up - Visit 4(D28): Safety follow-up and blood collection for immunogenicity assessment (only for subjects 18 years old and above) - V5(D168): Safety follow-up

NCT ID: NCT04154722 Completed - Typhoid Fever Clinical Trials

Comparison of Two Drugs Regimen in Treatment of Complicated Typhoid Fever in Children

[XDRTYPHOID]
Start date: June 20, 2019
Phase: Phase 4
Study type: Interventional

This study evaluates whether XDR Typhoid fever in children can be effectively treated with monotherapy (meropenum alone), or a combination (meropenum and azithromycin).

NCT ID: NCT04051268 Completed - Safety Issues Clinical Trials

Immunogenicity and Safety of Vi-DT (Diphtheria Toxoid) Typhoid Conjugate Vaccine (Phase III)

Start date: March 2, 2020
Phase: Phase 3
Study type: Interventional

Phase III study, Randomized, observer blind, lot to lot consistency, non inferiority to PQed typhoid conjugate vaccine and Typhoid Vi polysaccharide vaccine.

NCT ID: NCT03956524 Completed - Typhoid Fever Clinical Trials

Safety and Tolerability of Typhoid Conjugate Vaccine (EuTCV) in Healthy Adults

Start date: March 16, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of EuTCV, in comparison to TCV (Typbar-TCV™, Bharat Biotech) and Vi-Polysaccharide vaccine (Typhim Vi®, Sanofi Pasteur) in healthy adult volunteers.

NCT ID: NCT03926455 Completed - Typhoid Fever Clinical Trials

Safety and Immunogenicity of Typhax, a Typhoid Vaccine

Start date: March 28, 2016
Phase: Phase 1
Study type: Interventional

This was a randomized, double-blind, ascending dose study conducted at a single clinical research center.

NCT ID: NCT03889067 Completed - Clinical trials for Salmonella Typhi Infection

Understanding How Salmonella Typhi Infects Humans (Bottlenecks)

Start date: May 30, 2019
Phase: N/A
Study type: Interventional

Typhoid fever is an infection caused by the bacteria Salmonella Typhi (S. Typhi). S. Typhi causes disease principally in developing countries where communities do not have access to safe water or adequate sanitation. It is thought to cause illness in approximately 22 million people every year and up to 200,000 deaths, mostly in children. The bacteria are spread when faeces from infected individuals contaminate food and water sources. Symptoms of infection include headache, fever and general aches and pains. If not treated properly typhoid infection can lead to severe complications and even death. In this study the investigators aim to understand more about the S. Typhi bacteria and how S. Typhi causes a bloodstream infection after it has been ingested and passed into the gut. In spite of the extensive morbidity and mortality associated with bacterial blood stream infections (BSI), comparatively little is known about the pathogenesis. At a time of increasing antimicrobial resistance and a lack of new antimicrobial agents, understanding the pathogenesis of BSI is essential for efforts directed at prevention both of Salmonella Typhi and other bacterial species, particularly those that are restricted to humans.