Clinical trials: Enterobacteriaceae Infection
Healthy
A Study to Investigate the Safety and Immunogenicity of the SF2a-TT15 Synthetic Carbohydrate-based Conjugate Vaccine Against Shigella Flexneri 2a
A study among adults, children and infants in Kenya to determine if a new type of glycoconjugate vaccine incorporating a synthetic carbohydrate component is safe and induces immunity against Shigella.
- Trial name
- GlycoShig3 (NCT04602975)
- Testing
- Injection SF2A-TT15 10 µg Adjuvanted, Injection SF2A-TT15 10 µg, Injection SF2A-TT15 2 µg Adjuvanted
- Where
- Kenya
- Volunteers
- 248 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
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
Urinary Tract Infection, Complicated, Acute Pyelonephritis
Study of Cases of Serious Infections Due to Carbapenem-Resistant Enterobacteriaceae
A multi-center, retrospective study of cases of serious bacterial infections including complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP), Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Acquired…
- Conditions
- Urinary Tract Infection, Complicated, Acute Pyelonephritis, Hospital Acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia
- Trial name
- NCT02420366
- Where
- 22 sites in United States, Greece and 2 more
- Volunteers
- 257 people
- Sponsor
- Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)
Plague, Pneumonic, Plague
Trial of the Immunogenicity, Safety, and Tolerability of rF1V Vaccine With CpG 1018® Adjuvant Compared With rF1V Vaccine in Adults 18 to 55 Years of Age
Phase 2, Randomized, Active-Controlled, Observer-Blinded, Multicenter Trial of the Immunogenicity, Safety, and Tolerability of rF1V Vaccine with CpG 1018® Adjuvant Compared with rF1V Vaccine in Adults 18 to 55 Years of Age
- Conditions
- Plague, Pneumonic, Plague, Vaccine-Preventable Diseases
- Trial name
- NCT05506969
- Testing
- rF1V-1018, rF1V vaccine
- Where
- 6 sites in United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Dynavax Technologies Corporation
Diarrhea
Prevention of Travelers' Diarrhea in Subjects Traveling Outside the U.S.
The primary objective of this study is to assess the safety and tolerability of rifaximin 600 mg (3 x 200-mg tablets) once daily compared with placebo when taken for 14 days by healthy subjects to prevent travelers' diarrhea (TD)…
- Trial name
- NCT00328380
- Testing
- Rifaximin
- Where
- 3 sites in United States
- Volunteers
- 660 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
Typhoid Fever
Safety and Immunogenicity of Typhax, a Typhoid Vaccine
This was a randomized, double-blind, ascending dose study conducted at a single clinical research center.
- Trial name
- NCT03926455
- Testing
- Typhax (investigational typhoid fever candidate vaccine), Active Comparator Typhim Vi
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Matrivax Research and Development Corporation
Typhoid Fever
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Children, Older Infants and Infants
This phase 2 trial is aimed to obtain information on the safety and immunogenicity of the Vi-CRM197 in children and infants from various age groups in the Philippines where Typhoid Fever is highly endemic and an efficacious…
- Trial name
- NCT01437267
- Testing
- Vi-CRM197 vaccine, Pneumococcal conjugate vaccine, Vi Polysaccharide (PS) vaccine
- Where
- Philippines
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Novartis
Typhoid Fever
Non-inferiority and Safety Study of EuTCV Compared to Typbar-TCV in Healthy 6 Months-45 Years Aged Participants
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.
- Trial name
- NCT04830371
- Testing
- EuTCV (Vi-CRM Typhoid conjugate vaccine), Typbar-TCV
- Where
- 2 sites in Philippines
- Volunteers
- 444 people, healthy volunteers welcome
- Sponsor
- EuBiologics Co.,Ltd
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.)
Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP)
Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in Carbapenem-Resistant Enterobacteriaceae Infections
The study will evaluate the efficacy and safety of Meropenem and Pralurbactam versus Best Available Therapy in the treatment of Carbapenem-Resistant Enterobacteriaceae Infections.
- Conditions
- Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP), Complicated Intra-abdominal Infection (cIAI), Complicated Urinary Tract Infection (cUTI)
- Trial name
- NCT07089186
- Testing
- Meropenem and Pralurbactam, Best Available Therapy (e.g., colistin, meropenem, tegecycline, amikacinceftezidime-avibatam)
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Malnutrition; Mild, Iron-deficiency Anemia
The Effect of Fortified Growing-up Milk on Growth and Micronutrient Status of Nigerian Toddlers
It is well known than an important part of Nigerian children from the lower social economic class have nutrient deficiencies. Fortified products, such as growing up milks (GUM), may play an important role in reducing the risk and…
- Conditions
- Malnutrition; Mild, Iron-deficiency Anemia, Nutritional Stunting, Nutritional Wasting
- Trial name
- GaGA (NCT03411590)
- Testing
- Fortified milk Powder
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- FrieslandCampina WAMCO Nigeria PLC
Shigella, Diarrhea
First in Human Dose Escalation Study Evaluating the Safety and Immunogenicity of IVT's Shigella-04 Vaccine in Healthy Young Adults
Phase 1 trial to evaluate the Safety and Immunogenicity of Inventprise's (IVT) Shigella-04 in Healthy Young Adults
- Trial name
- NCT07205926
- Testing
- IVT Shigella-04
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Inventprise Inc.
Typhoid
Immunogenicity, Safety and Tolerability of the Typhoid Fever Vaccine Candidate M01ZH09 in Healthy Adults
This study is to investigate the safety, tolerability and immunogenicity of the typhoid fever vaccine candidate M01ZH09 manufactured at commercial scale, at a new manufacturing facility.
- Trial name
- NCT00679172
- Testing
- Dose of 5.0 x 10^9 CFU (Cohort 1), Dose of 7.5 x 10^9 CFU (Cohort 2), Dose of 1.1 x 10^10 CFU (Cohort 3)
- Where
- 3 sites in United States
- Volunteers
- 187 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Carbapenem-Resistant Enterobacteriaceae
Clinical Validation of the Molecular-Based GenePOC Carba Assay for the Detection and Differentiation of Carbapenemase Genes in Rectal Swab Samples.
The primary purpose of this clinical investigation is to establish the performance of the GenePOC Carba assay on the revogene. This will be achieved by comparing the test to a conventional method for detection of Carbapenemase…
- Trial name
- NCT03680898
- Testing
- Rectal swab collection
- Where
- 3 sites in United States, Canada
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- Meridian Bioscience, Inc.
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
E Coli Infections, Allogenic Transplant Patients
Phase 1b/2a Randomized Double-blind Study to Investigate Safety Tolerability PK PD Preliminary Efficacy of Oral Administration of SNIPR001 in Patients With Hematologic Malignancy Scheduled for Allogeneic Hematopoietic Stem-Cell Transplant Receiving FQ Prophylaxis & Harboring FQR Ecoli Pre-Transplant
This is a Phase 1b/2a study in allogenic hematopoietic stem cell transplant patients to investigate the safety, PK, PD and preliminary efficacy of multiple oral administrations of SNIPR001 when given concomitantly with SoC…
- Trial name
- NCT06938867
- Testing
- SNIPR001 consists of genetically modified bacteriophages specifically targeting Escherichia coli
- Where
- 10 sites in United States
- Volunteers
- 66 people
- Sponsor
- SNIPR Biome Aps.
Hospital Acquired Pneumonia, Ventilator Acquired Pneumonia
Real-World Study of Ceftazidime Avibactam in China
This observational study will enroll approximately 450 in patients. Patients treated with CAZ AVI for at least 1 dose at around 20 research centers in China will be enroll.
- Conditions
- Hospital Acquired Pneumonia, Ventilator Acquired Pneumonia, Complicated Intra Abdominal Infections
- Trial name
- REACT (NCT05487586)
- Testing
- ceftazidime avibactam group
- Where
- 17 sites in China
- Volunteers
- 220 people
- Sponsor
- Pfizer