Clinical trials: Enterobacteriaceae Infections
Shigellosis
A Study to Determine If a New Shigella Vaccine is Safe, Induces Immunity and The Best Dose Among Kenyan Infants
In this study, the tetravalent bioconjugate candidate vaccine Shigella4V will be tested to obtain first-in-human data on its safety and immunogenicity in infants and to identify the preferred dose of Shigella4V in 9 month old…
- Trial name
- NCT04056117
- Testing
- Shigella 4V, MenACWY, Rabies
- Where
- 2 sites in Kenya
- Volunteers
- 597 people, healthy volunteers welcome
- Sponsor
- LimmaTech Biologics AG
Urinary Tract Infection
Temocillin Use in Complicated Urinary Tract Infections Due to Extended Spectrum Beta-Lactamases (ESBL)/AmpC Enterobacteriaceae
This study is aimed at demonstrating the efficacy of temocillin in the treatment of complicated Urinary Tract Infection (UTI) due to confirmed Extended Spectrum Beta-Lactamases (ESBL) producing or AmpC hyperproducing…
- Trial name
- TEA (NCT01543347)
- Testing
- Temocillin
- Where
- United Kingdom
- Sponsor
- Belpharma s.a.
Escherichia Coli Bacteremia, Klebsiella Bacteraemia
Switch to Oral Antibiotics in Gram-negative Bacteremia
Eligible subjects will be those age 18 years or more with mono-microbial blood stream infection caused by E. coli, Klebsiella species, Enterobacter species, Serratia species, Citrobacter species, or Proteus species, who have…
- Conditions
- Escherichia Coli Bacteremia, Klebsiella Bacteraemia, Enterobacter Bacteraemia, Serratia Bacteraemia
- Trial name
- SOAB (NCT04146922)
- Testing
- Step down to oral antimicrobial therapy, IV antimicrobial therapy
- Where
- 7 sites in Bahrain, Kuwait and 2 more
- Volunteers
- 176 people
- Sponsor
- Hamad Medical Corporation
Typhoid Fever
Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of Typhoid Fever Vaccine (Ty800) in Healthy Adult Subjects
The purpose of this trial is to examine the safety and immunogenicity of Ty800 oral vaccine in healthy adult subjects.
- Trial name
- NCT00498654
- Testing
- Ty800 (Salmonella typhi) Oral Vaccine
- Where
- 5 sites in United States
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Avant Immunotherapeutics
Typhoid Fever
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adults, Children, Older Infants and Infants
This phase 2 trial is aimed to obtain information on the safety and immunogenicity of the Vi-CRM197 in subjects from various age groups in India and Pakistan where Typhoid Fever is highly endemic and an efficacious vaccine…
- Trial name
- NCT01229176
- Testing
- Vi-CRM197 vaccine, Vi Polysaccharide (PS) vaccine, Pneumococcal conjugate vaccine
- Where
- 2 sites in India, Pakistan
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Novartis
Pneumonic Plague, Preventive Therapy
Safety, Tolerability & Immunogenicity of the Recombinant Plague Vaccine rF1V
The purpose of this study is to evaluate the safety and tolerability of a two-dose schedule of the recombinant plague vaccine rF1V in healthy volunteers when given as an intramuscular (IM) injection at four ascending dose-levels.
- Trial name
- NCT00097396
- Testing
- rF1V vaccine
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- DynPort Vaccine Company LLC, A GDIT Company
Diarrhea
ETEC Logistics Trial (TREK)
This is a multicenter, double-blind, randomized, placebo-controlled field trial to evaluate the epidemiology of natural infection with ETEC occurring after transcutaneous immunization in a field setting.
- Trial name
- Trek (NCT00516659)
- Testing
- Heat-Labile Enterotoxin of Escherichia coli (LT)
- Where
- 19 sites in United States, Guatemala and 1 more
- Volunteers
- 201 people, healthy volunteers welcome
- Sponsor
- Intercell USA, Inc.
Plague, Plague, Bubonic
Yersinia Pestis Lateral Flow Immunoassay for Blood Samples
Plague is a deadly but highly treatable disease caused by the bacterium Y. pestis. Due to the historical development of Y. pestis as a bioweapon by several nation states, it is listed by the US as a potential bioweapon that could…
- Conditions
- Plague, Plague, Bubonic, Plague, Pneumonic, Yersinia Pestis Plague
- Trial name
- SMARTPRT (NCT04688996)
- Testing
- Lateral Flow Assay for Pathogens of the Plague
- Where
- 2 sites in United States, Madagascar
- Volunteers
- 500 people
- Sponsor
- Brimrose Technology Corporation
Typhoid Fever
Safety and Tolerability of Typhoid Conjugate Vaccine (EuTCV) in Healthy Adults
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.
- Trial name
- NCT03956524
- Testing
- EuTCV, Typbar-TCV™, Typhim Vi®
- Where
- Philippines
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- EuBiologics Co.,Ltd
Dysentery, Dysentery, Bacillary
Immunogenicity and Safety of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 3 Months to 5 Years Old
The purpose of this study is to evaluate immunogenicity and safety of S.flexneriza-S.sonnei Bivalent Conjugate Vaccine in healthy volunteers aged from 3 months to 5 years old.
- Trial name
- NCT04865497
- Testing
- S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine, Haemophilus b Conjugate Vaccine
- Where
- China
- Volunteers
- 1,050 people, healthy volunteers welcome
- Sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Uncomplicated Urinary Tract Infections, Urinary Tract Infections
Safety, Tolerability, Pharmacokinetic and Microbiological Investigation of GSK3882347 in Female Participants With Urinary Tract Infections
This phase 1b study is a double-blind, double-dummy, nitrofurantoin-controlled study designed to evaluate microbiological response at the test of cure (ToC) visit along with safety, tolerability and pharmacokinetic (PK) response…
- Trial name
- NCT05138822
- Testing
- GSK3882347, Nitrofurantoin
- Where
- 15 sites in United States
- Volunteers
- 140 people
- Sponsor
- GlaxoSmithKline
Urinary Tract Infections
A Study on the Safety and Immune Response of a Urinary Tract Infection (UTI) Vaccine in Adults 18-64 Years of Age and Clinical Efficacy in Females 18-64 Years of Age
The purpose of this study is to assess safety, reactogenicity, and immune response of the candidate UTI vaccine compared to placebo in adults between and including 18-64 years of age (YOA), and to perform a preliminary evaluation…
- Trial name
- NCT06702449
- Testing
- Candidate UTI vaccine low dose formulation 1, Candidate UTI vaccine low dose formulation 2, Candidate UTI vaccine medium dose formulation 1
- Where
- 8 sites in United States, South Africa
- Volunteers
- 448 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Shigellosis
A Phase 1, Dose Escalation Study, to Evaluate a New Shigella Sonnei Vaccine in Healthy Adults.
This Phase 1 clinical trial is aimed to evaluate the safety and immunogenicity of 3 doses of 5 sequentially escalating dosages of a candidate vaccine against Shigella sonnei (1790GAHB vaccine) administered by intramuscular route…
- Trial name
- NCT02017899
- Testing
- S. sonnei 1790GAHB
- Where
- France
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- GSK Vaccines Institute For Global Health S.r.l.
Healthy Volunteers
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK, the Measure of How the Human Body Processes a Substance) of ETX0282 When Administered Orally to Healthy Participants
This research project is being conducted to investigate the safety, tolerability, and pharmacokinetics (PK) of a single ascending dose (SAD) and multiple ascending doses (MAD) of oral ETX0282 when administered alone and in…
- Trial name
- NCT03491748
- Testing
- ETX0282, Cefpodoxime proxetil
- Where
- Australia
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- Entasis Therapeutics
Shigellosis
A Human Challenge Study to Assess Protection of a Shigella Tetravalent Bioconjugate Vaccine
In this challenge study, the bioconjugate candidate vaccine Shigella4V2 will be tested for its ability to induce an immune response that protects healthy adult volunteers from infection with a wild-type Shigella sonnei strain…
- Trial name
- S4V03 (NCT06615375)
- Testing
- Shigella4V2
- Where
- 3 sites in United States
- Volunteers
- 97 people, healthy volunteers welcome
- Sponsor
- LimmaTech Biologics AG
Typhoid Fever
Safety and Immunogenicity of Three Formulations of Vi-CRM197 Vaccine Against S. Typhi in Adults (18-40 Years Old)
This trial is aimed to evaluate the safety and immunogenicity profiles of three formulations of Vi-CRM197 conjugate vaccine against S.
- Trial name
- NCT01193907
- Testing
- NVGH Vi-CRM197 12.5 mcg, NVGH Vi-CRM197 5.0 mcg, NVGH Vi-CRM197 1.25 mcg
- Where
- Belgium
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Novartis
Shigella Infection
Healthy Adult Volunteer Study for Two Doses of a Shigella Vaccine
The purpose of this study is to assess the immune response produced by two doses of SC599 vaccine compared to placebo.
- Trial name
- NCT00210288
- Testing
- SC599
- Where
- 2 sites in France, United Kingdom
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
Shigellosis
Safety and Reactogenicity of Bioconjugate Vaccine to Prevent Shigella
Healthy volunteers will receive a 2-dose vaccination with Shigella dysenteriae candidate vaccine spaced 8 weeks apart. The objective is to demonstrate the safety and reactogenicity of the Shigella dysenteriae bioconjugate vaccine…
- Trial name
- NCT01069471
- Testing
- Shigella vaccine
- Where
- Switzerland
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- GlycoVaxyn AG
Detection Accuracy, Patient Compliance
Reliability, Safety and Usability of the Transplantation Sensor System Combined With Myfortic® in Adult Kidney Transplant Patients
The main purpose of this exploratory trial is to evaluate the reliability, safety and usability of the Transplantation Sensor System when the Ingestible Event Marker (IEM) is given in combination with ECMPS 360 mg tablets in…
- Trial name
- NCT01320358
- Testing
- ECMPS-IEM
- Where
- 5 sites in Switzerland
- Volunteers
- 30 people
- Sponsor
- Novartis Pharmaceuticals
Shigellosis
Safety and Efficacy of the Bacteriophage Preparation, ShigActive™, in a Human Experimental Model of Shigellosis
The study is a first-in-human Phase 1/2a randomized, double-blind, placebo-controlled trial to assess the clinical safety and efficacy of ShigActive in healthy adults with experimental Shigella challenge.
- Trial name
- NCT05182749
- Testing
- bacteriophage
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Intralytix, Inc.