Clinical trials: Enterobacteriaceae Infection
Typhoid Fever
Safety and Immunogenicity of a Novel Conjugate Vaccine Against Salmonella Typhi and Salmonella Paratyphi A in Healthy Adults
A bivalent Typhoid and Paratyphoid A conjugate investigational vaccine aimed to prevent both typhoid and paratyphoid enteric fever in infants and older age groups has been developed by GlaxoSmithKline (GSK).
- Trial name
- NCT05613205
- Testing
- TYP04A Low Dose without Alum investigational vaccine, TYP04B Full Dose without Alum investigational vaccine, TYP03A Low Dose with Alum investigational vaccine
- Where
- Belgium
- Volunteers
- 97 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Urinary Tract Infection Complicated, Acute Pyelonephritis
Efficacy, Safety, Tolerability of Vabomere Compared to Best Available Therapy in Treating Serious Infections in Adults
Vabomere™, (meropenem-vaborbactam) is being compared to the Best Available Therapy in the treatment of adults with selected serious infections due to Carbapenem Resistant Enterobacteriaceae
- Conditions
- Urinary Tract Infection Complicated, Acute Pyelonephritis, Hospital Acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia
- Trial name
- NCT02168946
- Testing
- Vabomere, Best Available Therapy
- Where
- 50 sites in United States, Argentina and 6 more
- Volunteers
- 77 people
- Sponsor
- Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)
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
Salmonella Infections
A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella and Typhoid Fever
The purpose of this study is to assess the safety, reactogenicity, and immune response induced by the GlaxoSmithKline Biologicals SA (GSK) Vaccines Institute for Global Health (GVGH) invasive nontyphoidal Salmonella-typhoid…
- Trial name
- NCT05480800
- Testing
- Invasive nontyphoidal Salmonella-typhoid conjugate vaccine (iNTS-TCV) low dose, Invasive nontyphoidal Salmonella-generalized modules for membrane antigens vaccine (iNTS-GMMA) low dose, Typhoid conjugate vaccine (TCV) low dose
- Where
- 2 sites in Belgium, Malawi
- Volunteers
- 155 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Meningococcal Disease, Meningococcal Meningitis
A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With MenACWY in Adults
This study compares the safety and immunogenicity profile of several travel vaccines given alone or concomitantly with MenACWY-CRM to healthy adults.
- Conditions
- Meningococcal Disease, Meningococcal Meningitis, Typhoid, Yellow Fever
- Trial name
- NCT01466387
- Testing
- Typhoid Vi Polysaccharide Vaccine, Yellow Fever Vaccine, Japanese Encephalitis Vaccine
- Where
- 5 sites in Czechia, Germany
- Volunteers
- 552 people, healthy volunteers welcome
- Sponsor
- Novartis
Diarrhea
Dose Escalating Study of Intramuscular Invaplex[AR-DETOX]
The main purpose of this study is to evaluate the safety of a Shigella flexneri 2a detoxified artificial invasin complex (Invaplex[AR-Detox]) vaccine candidate administered by intramuscular immunization.
- Trial name
- NCT03869333
- Testing
- Invaplex[AR-DETOX]
- Where
- United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- PATH
Escherichia Coli Diarrhea
Enterotoxigenic Escherichia Coli (ETEC) ETVAX Vaccine Trial in Bangladesh
The purpose of this study is to determine if the ETEC vaccine ETVAX with and without dmLT adjuvant is safe and immunogenic in adults, children, toddlers and infants in Bangladesh.
- Trial name
- ETVAX/dmLT (NCT02531802)
- Testing
- ETVAX, dmLT, Bicarbonate Buffer
- Where
- Bangladesh
- Volunteers
- 475 people, healthy volunteers welcome
- Sponsor
- PATH
Gastroenteritis Escherichia Coli, Immunisation
A Double-Blind Placebo-Control Dose Escalating Study to Evaluate the Safety and Immunogenicity of dmLT by Oral, Sublingual and Intradermal Vaccination in Adults Residing in an Endemic Area
This is a trial to evaluate the safety and immunogenicity of double mutant heat-labile toxin LTR192G/L211A (dmLT) from Enterotoxigenic Escherichia coli (ETEC) by oral, sublingual, or intradermal vaccination in approximately 135…
- Trial name
- NCT03548064
- Testing
- Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine
- Where
- 2 sites in United States, Bangladesh
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Diarrhea
Shigella WRSS1 Vaccine Trial in Bangladesh
This is a research study of an experimental (investigational) live attenuated Shigella sonnei vaccine (WRSS1) to find a dose of the vaccine that is safe, tolerable, and develops an immune response.
- Trial name
- NCT02934178
- Testing
- Shigella sonnei Strain WRSS1 Vaccine
- Where
- Bangladesh
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- PATH
Spinal Cord Injury, Urinary Tract Infection
Colonizing Neurogenic Bladders With Benign Flora
The purpose of the research is to determine whether we can get harmless bacteria to live in the bladders of persons with spinal cord injury who practice intermittent bladder catheterization.
- Trial name
- NCT00371631
- Testing
- Insertion of urinary catheters coated with E. coli 83972
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- US Department of Veterans Affairs
Healthy Volunteer
Efficacy of B7A BSIgG Against E. Coli Strain B7A Challenge
Enterotoxigenic Escherichia coli (ETEC) is a major cause of diarrhea worldwide. Vaccines and therapeutics are under development to prevent ETEC disease in children and travelers.
- Trial name
- NCT03040687
- Testing
- Anti CS6 BSIgG product (Lot PD1601105CS), Anti B7A BSIgG product (Lot PD1601132ET), Bovine Immunoglobin Negative Control (Lot PD161071NC)
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Lung Diseases, Obstructive, Sarcoidosis
Interventional Cryotherapy for the Eradication of Benign Airway Disease ("ICE the BAD")
The purpose of this study is to evaluate the safety, effectiveness, and side effects of the CryoSpray AblationTM System (CryoSpray AblationTM, "CSA" or "cryospray therapy") to treat benign airway disease in the lung using liquid…
- Conditions
- Lung Diseases, Obstructive, Sarcoidosis, Wegener's Granulomatosis, Rhinoscleroma
- Trial name
- ICEtheBAD (NCT00747461)
- Testing
- CryoSpray Ablation
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- CSA Medical, Inc.
Diarrhea
Safety Study of Live Attenuated Oral Shigella (WRSS1) Vaccine in Bangladeshi Adults and Children
This is a research study about an experimental (investigational) oral Shigella sonnei - Walter Reed S. sonnei (WRSS1). WRSS1 is a live vaccine that is being made to prevent disease from Shigella, which causes bloody, watery…
- Trial name
- NCT01813071
- Testing
- WRSS1
- Where
- Bangladesh
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- PATH
Salmonella Infections, Typhoid Fever
Study of a Single Dose of SP093 Typhoid Vi Polysaccharide Vaccine in Japanese Subjects
This study is designed to assess the immunogenicity and safety of typhoid Vi polysaccharide vaccine in Japanese participants to support registration of the product in Japan.
- Conditions
- Salmonella Infections, Typhoid Fever, Bacterial Infections
- Trial name
- NCT01608815
- Testing
- Typhoid Vi polysaccharide
- Where
- 3 sites in Japan
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Urinary Tract Infection
Cranberry for UTI Prevention in Residents of Long Term Care Facilities
Urinary tract infections (UTIs) affect over 7 million men and women per year and cost the health care industry over 1 billion dollars annually.
- Trial name
- PACS (NCT00596635)
- Testing
- Once Daily Cranberry Capsule, Twice Daily Cranberry Capsules
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Yale University
Diarrhoea
A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants
The aim of the current clinical study was to evaluate, for the first time in humans (FTIH), the safety and immunogenicity of the altSonflex1-2-3 candidate vaccine against S. sonnei and S. flexneri serotypes 1b, 2a, and 3a.
- Trial name
- NCT05073003
- Testing
- AltSonflex1-2-3 High Dose, AltSonflex1-2-3 Medium Dose, AltSonflex1-2-3 Low Dose
- Where
- 2 sites in Belgium, Kenya
- Volunteers
- 551 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Shigellosis
Safety Study of Inactivated Shigella Whole Cell Vaccine in Adults
This is a research study about an experimental (investigational) oral inactivated whole cell Shigella flexneri 2a killed vaccine (Sf2aWC).
- Trial name
- NCT01509846
- Testing
- Vaccine: 2.6±0.8 x 10^8 vp/mL, 1 dose, Vaccine: 2.6±0.8 x 10^9 vp/mL, 3 doses, Vaccine: 2.6±0.8 x 10^10 vp/mL, 3 doses
- Where
- 2 sites in United States
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- PATH
Intra-abdominal Infections
LYS228 PK, Clinical Response, Safety and Tolerability in Patients With Complicated Intra-abdominal Infection (cIAI)
The purpose of the study was to evaluate whether LYS228 can be developed for the treatment of complicated intra-abdominal infections.
- Trial name
- NCT03354754
- Testing
- LYS228, Standard of care therapy
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Novartis Pharmaceuticals
Shigellosis, Bacillary Dysentery
Safety and Immunogenicity of Artificial Invaplex (Shigella Flexneri 2a InvaplexAR)
This study is an open-label, dose-escalating Phase 1 investigation of S. flexneri 2a InvaplexAR vaccine. A total of up to 40 subjects will receive one of four S. flexneri 2a InvaplexAR vaccine doses.
- Trial name
- NCT02445963
- Testing
- Shigella flexneri 2a InvaplexAR
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command