Clinical trials: Gram-Negative Bacterial Infections
Shiga Toxin Producing Bacterial Infection
Study of Chimeric Monoclonal Antibodies to Shiga Toxins 1 and 2
This study is designed to evaluate the safety and efficacy of cαStx1 and cαStx2 administered concomitantly in children presenting early signs of Shiga Toxin-Producing Bacterial (STPB) Infection.
- Trial name
- NCT01252199
- Testing
- cαStx1/cαStx2
- Where
- 11 sites in Argentina, Chile and 1 more
- Volunteers
- 45 people
- Sponsor
- Thallion Pharmaceuticals
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.
Healthy Volunteers (Meningococcal Infection)
Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
The primary objective of this study was to describe the safety profile of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) Conjugate Vaccine and Meningococcal (Groups A, C, Y and W 135)…
- Trial name
- MET41 (NCT03673462)
- Testing
- Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine (MenACYW Conjugate vaccine), Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®), Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine
- Where
- 69 sites in United States, Puerto Rico
- Volunteers
- 2,797 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Helicobacter Infections
Endofaster Test for Helicobacter Pylori Detection in Patients on Proton Pump Inhibitor Therapy
H. pylori infection is the most important causative agent of gastritis, and subsequent atrophic gastritis. The endoscopic diagnosis of H. pylori infection relies on urease tests such as the Clo test.
- Trial name
- NCT02126722
- Testing
- Gastroscopy, EndoFaster test, Clo test
- Where
- United Kingdom
- Volunteers
- 150 people
- Sponsor
- Niso Biomed S.R.L.
Hepatitis B
Immune Response Post Pry Vaccination of 2 Formulations of DTPw-HBV Vaccine Given With Rotavirus Vaccine to Infants
To compare the two formulations of GSK Biologicals' DTPw-HBV vaccine to concomitant administration of CSL's DTPw vaccine and GSK Biologicals' HBV with respect to the antibody response to the diphtheria antigen after a three-dose…
- Trial name
- NCT00158756
- Testing
- Tritanrix™-HepB, Rotarix™, Zilbrix™
- Where
- 9 sites in Russia
- Volunteers
- 308 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Meningococcal
The Long-term Antibody Persistence of GSK Biologicals' Meningococcal Vaccine GSK134612 in Healthy Toddlers
In this study, the concentration of antibody to the vaccine one year, three and five years after vaccination in subjects who were vaccinated with GSK Biologicals' meningococcal vaccine GSK134612 in a previous study (whose…
- Trial name
- NCT00718666
- Testing
- Meningococcal vaccine GSK134612
- Where
- 14 sites in United States
- Volunteers
- 387 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Meningitis, Meningococcal Infection
Study of a Single Dose of Menactra® Vaccine 4-6 Years After Prior Menactra Vaccine
The purpose of this trial is to describe the safety and antibody response to revaccination with Menactra vaccine in persons who received their first dose at ≥11 years of age.
- Trial name
- NCT01442675
- Testing
- Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate: Menactra®
- Where
- 15 sites in United States
- Volunteers
- 834 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Enteric Fever
Study to Evaluate the Safety, Tolerability and Immunogenicity of a Potential Enteric Fever Vaccine
A Phase 1, randomised, double-blind, placebo-controlled, parallel group study in 45 healthy participants aged 18 to 45 years inclusive.
- Trial name
- NCT04349553
- Testing
- ZH9PA and ZH9, ZH9PA
- Where
- United Kingdom
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Prokarium Ltd
Infections, Meningococcal
Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine Given as One Dose to Healthy Subjects Above 56 Years
This study evaluates the immunogenicity and safety of the meningococcal conjugate vaccine GSK 134612 given as single dose to healthy adults 56 years or older compared to the meningococcal polysaccharide vaccine MencevaxACWYTM.
- Trial name
- NCT01235975
- Testing
- Meningococcal vaccine GSK 134612, MencevaxACWY TM
- Where
- Lebanon
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pertussis
Pertussis Acellular Vaccine Adjuvanted With TQL1055
This is a phase 1 study to evaluate the safety and immunogenicity of the semisynthetic saponin adjuvant TQL1055 administered in combination with an acellular pertussis vaccine.
- Trial name
- NCT04793620
- Testing
- TQL1055, Acellular pertussis vaccine
- Where
- Australia
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Adjuvance Technologies, Inc.
Meningococcal Infections, Meningitis
Safety and Immunogenicity of Intradermal Versus Subcutaneous Doses of Menomune®
The objective of this trial is to study the administration of the Menomune vaccine given intradermally and low-dose subcutaneously versus standard subcutaneously.
- Trial name
- NCT00850603
- Testing
- Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
- Where
- United States
- Volunteers
- 170 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Epidemic Meningitis, Meningococcal Vaccines
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 6-11 Months
The goal of this clinical trial is to evaluate the immunogenicity, safety, and persistence of the immune response of a group ACYW135 meningococcal conjugate vaccine in healthy children aged 6 to 11 months.
- Trial name
- NCT07505823
- Testing
- experimental vaccine, Active Comparator vaccine
- Where
- 2 sites in China
- Volunteers
- 1,040 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech Co., Ltd
Gonorrhea
Comparison of Delafloxacin Versus Ceftriaxone for the Treatment of Uncomplicated Gonorrhea
The purpose of this study is to evaluate the effects of a single oral dose of delafloxacin versus a single intramuscular injection of ceftriaxone in subjects with uncomplicated cervical, urethral, rectal, or pharyngeal gonorrhea.
- Trial name
- NCT02015637
- Testing
- Delafloxacin, Ceftriaxone
- Where
- 25 sites in United States
- Volunteers
- 460 people
- Sponsor
- Melinta Therapeutics, Inc.
Chlamydial Infections
Validation of Chlamydia Diagnostic Codes in TriNetX US EHR Data
This study is a pharmacoepidemiologic method study based on the secondary use of pre-existing data that examines whether TriNetX, a global health research network encompassing a worldwide electronic health record (EHR), database…
- Trial name
- NCT07094373
- Where
- United States
- Volunteers
- 4,878,935 people
- Sponsor
- Sanofi
Haemophilus Influenzae Type b, Neisseria Meningitidis
Safety, Reactogenicity & Immunogenicity Study to Evaluate a Booster Dose of GSK Biologicals' Hib-MenC Given With Priorix™ in Toddlers (13-14 m) Primed With 3 Doses of Hib and MenC-CRM197
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a booster dose of the candidate Hib-MenC conjugate vaccine given concomitantly with measles, mumps and rubella (MMR) vaccine, versus…
- Trial name
- NCT00263653
- Testing
- Haemophilus influenzae type b- and meningococcal (vaccine)
- Where
- 16 sites in Spain
- Volunteers
- 297 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Tetanus
Immunogenicity and Safety of Pentaxim™ in an Indian Population
The present clinical study will assess the immunogenicity as the primary objective and the reactogenicity as the secondary objective of Aventis Pasteur's DTacP-IPV// PRP~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose…
- Conditions
- Diphtheria, Tetanus, Polio, Pertussis
- Trial name
- NCT00259337
- Testing
- Diphteria/Tetanus/Polio/Acellular Pertussis/Hib vaccine
- Where
- India
- Volunteers
- 226 people, healthy volunteers welcome
- Sponsor
- Sanofi
Cystic Fibrosis, Lung Infection
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa
The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF), mild lung disease (forced expiratory volume in 1 second…
- Conditions
- Cystic Fibrosis, Lung Infection, Pseudomonas Aeruginosa
- Trial name
- AIR-CF4 (NCT00712166)
- Testing
- AZLI 75 mg three times daily (TID)
- Where
- 40 sites in United States, Australia and 1 more
- Volunteers
- 160 people
- Sponsor
- Gilead Sciences
Whooping Cough
Effectiveness of Maternal Immunization With Boostrix at Preventing Pertussis Among Infants <2 Months Old in the United States
The purpose of this study is to estimate the effectiveness of maternal immunization with Boostrix at preventing pertussis in infants in the United States.
- Trial name
- NCT03973905
- Testing
- Not applicable / dataset analysis
- Where
- Belgium
- Volunteers
- 290 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pneumonia, Bacterial
Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia
To demonstrate that as adjunctive therapy to intravenous (IV) antibiotics, BAY 41-6551 400 mg (amikacin as free base) administered as an aerosol by the Pulmonary Drug Delivery System (PDDS) Clinical every 12 hours is safe and…
- Trial name
- INHALE 1 (NCT01799993)
- Testing
- Amikacin Inhalation Solution (BAY41-6551)
- Where
- 65 sites in United States, Australia and 10 more
- Volunteers
- 725 people
- Sponsor
- Bayer
Diphtheria, Tetanus
A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series
The purpose of this study is to evaluate immunogenicity, safety and lot-to-lot consistency of LBVD in comparison to co-administration of Pentavalent vaccine and Poliomyelitis Vaccine (Inactivated) in separate injections at four…
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT06947499
- Testing
- LBVD, Pentavalent vaccine and Inactivated Polio vaccine
- Where
- Philippines
- Volunteers
- 1,186 people, healthy volunteers welcome
- Sponsor
- LG Chem