Clinical trials: Gram-Negative Bacterial Infections
Hepatitis B, Polio
Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule
To demonstrate that the immune response to hepatitis B antigen of the DTaP-IPV-Hep B-PRP~T is non-inferior to that of the association of PENTAXIM™ and ENGERIX B® one month after a three dose (2-3-4 month) primary series.
- Conditions
- Hepatitis B, Polio, Diphtheria, Pertussis
- Trial name
- NCT00315055
- Testing
- DTaP-IPV-HB-PRP~T vaccine, DTaP-IPV//PRP~T combined, Hepatitis B vaccine
- Where
- Turkey (Türkiye)
- Volunteers
- 310 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Meningitis, Meningococcal Infection
A Study of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine in Infants and Toddlers
The purpose of this study was to evaluate the optimal vaccination schedule for a Quadrivalent Meningococcal Polysaccharide (A, C, Y and W-135) Tetanus Protein Conjugate Vaccine (MenACYW Conjugate vaccine) in order to provide an…
- Trial name
- NCT01049035
- Testing
- Quadrivalent Meningococcal Polysaccharide (A, C, Y, and W-135) Tetanus Protein Conjugate, Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined), M-M-RII-Measles, Mumps, and Rubella Virus Vaccine Live
- Where
- 25 sites in United States
- Volunteers
- 580 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Diabetic Foot Ulcer, Pseudomonas Aeruginosa Infection
Bacteriophage Therapy TP-102 in Diabetic Foot Ulcers
This is a Phase I/IIa trial designed to evaluate topical bacteriophage therapy in patients with diabetic foot ulcers.
- Conditions
- Diabetic Foot Ulcer, Pseudomonas Aeruginosa Infection, Staphylococcus Aureus Infection, Acinetobacter Infection
- Trial name
- REVERSE (NCT04803708)
- Testing
- TP-102
- Where
- 2 sites in Israel
- Volunteers
- 20 people
- Sponsor
- Technophage, SA
Meningitis, Meningococcal
Study Evaluating the Safety, Immunogenicity and Tolerability of Meningococcal Group B Vaccine in Healthy Adults
To determine the safety \& immunogenicity of a potential vaccine against meningococcal B disease
- Trial name
- NCT00297687
- Testing
- MnB rLP2086
- Where
- 3 sites in Australia
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Meningitis, Meningococcal
Study Evaluating Safety And Tolerability Of Meningococcal B Rlp2086 Vaccine In Healthy Adults
The purpose of this study is to evaluate the safety and tolerability of an investigational meningococcal B rLP2086 vaccine in healthy adults.
- Trial name
- NCT00879814
- Testing
- rLP2086 vaccine or control
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Pfizer
Gram-negative Bacterial Infections
A Study to Investigate the Intrapulmonary Lung Penetration of Nacubactam in Healthy Participants
The purpose of this study is to characterize the intrapulmonary penetration of nacubactam in healthy volunteers. Nacubactam is a novel non-beta-lactam beta-lactamase inhibitor being developed as a combination therapy with the…
- Trial name
- NCT03182504
- Testing
- nacubactam, meropenem
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Hepatitis B, Tetanus
Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants
This study will evaluate GSK Biologicals' DTPa-HBV-IPV/Hib vaccine given as a three-dose primary vaccination course at 2, 4 and 6 months of age, in terms of safety and immunogenicity in different population of infants residing in…
- Conditions
- Hepatitis B, Tetanus, Poliomyelitis, Diphtheria
- Trial name
- NCT00753649
- Testing
- Infanrix™ hexa
- Where
- 3 sites in Canada
- Volunteers
- 224 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthcare-associated Pneumonia (HCAP), Hospital Acquired Pneumonia (HAP)
Clinical Study of Cefiderocol (S-649266) for the Treatment of Nosocomial Pneumonia Caused by Gram-negative Pathogens
The primary objective of this study is to compare all-cause mortality at Day 14 in participants receiving cefiderocol with participants receiving the comparator, meropenem, in adults with hospital-acquired bacterial pneumonia…
- Conditions
- Healthcare-associated Pneumonia (HCAP), Hospital Acquired Pneumonia (HAP), Ventilator Associated Pneumonia (VAP)
- Trial name
- APEKS-NP (NCT03032380)
- Testing
- Cefiderocol, Meropenem, Linezolid
- Where
- 119 sites in United States, Belgium and 17 more
- Volunteers
- 300 people
- Sponsor
- Shionogi
Gonorrhea
A Dose-Ranging Study Evaluating the Efficacy, Safety, and Tolerability of GSK2140944 in the Treatment of Uncomplicated Urogenital Gonorrhea Caused by Neisseria Gonorrhoeae
GSK2140944 has demonstrated in vitro activity against Neisseria (N.) gonorrhoeae, including ciprofloxacin resistant and susceptible strains.
- Trial name
- NCT02294682
- Testing
- GSK2140944
- Where
- 14 sites in United States, Puerto Rico and 1 more
- Volunteers
- 106 people
- Sponsor
- GlaxoSmithKline
Diarrheal Disease, Infectious, Gastrointestinal Disease
Phase 1 Trial for Safety, Tolerability, and Immunogenicity of a Live, Attenuated, Oral Shigella/ETEC Combination Vaccine to Healthy Adults
This is a Phase 1 dose escalating study to assess the safety, tolerability, and immunogenicity of ShigETEC, a live, attenuated Shigella/ETEC combination vaccine given orally to healthy European adults 18 to 45 years of age.
- Conditions
- Diarrheal Disease, Infectious, Gastrointestinal Disease, Reactive Arthritis
- Trial name
- NCT05409196
- Testing
- ShigETEC live, attenuated, oral vaccine
- Where
- Hungary
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Eveliqure Biotechnologies GmbH
Lyme Disease
Biomarker Study of Previously Treated Lyme Disease Volunteers in Comparison to Healthy Volunteers
Non-interventional study evaluating stool and blood samples collected from individuals previously treated with Lyme disease versus healthy volunteers
- Trial name
- NCT04835792
- Testing
- Stool and blood collection
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- FlightPath Biosciences, Inc.
Diphtheria, Tetanus
Study of the Effect of Pneumococcal Conjugate Vaccine (PCV) on Immunogenicity of Pentacel™
This study is designed to evaluate in a controlled manner the effect of Prevnar® on the immune responses of Pentacel™ Primary Objective - Stage I: To compare the immune responses elicited by an infant series of Pentacel™ when…
- Conditions
- Diphtheria, Tetanus, Haemophilus Infection, Pertussis
- Trial name
- NCT00772928
- Testing
- Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®
- Where
- 23 sites in United States
- Volunteers
- 1,167 people, healthy volunteers welcome
- Sponsor
- Sanofi
Gram-negative Bacterial Infection
Evaluation of Pharmacokinetics, Safety, and Tolerability of Ceftazidime-avibactam in Neonates and Infants.
This study will assess the pharmacokinetics, safety, and tolerability of single and multiple doses of intravenous ceftazidime-avibactam in hospitalized infants and neonates from 26 weeks gestation to 3 months of age.
- Trial name
- NOOR (NCT04126031)
- Testing
- Part A: Single Dose Ceftazidime-Avibactam, Cohorts 1-3, Part B: Multiple-dose Ceftazidime-Avibactam, Cohorts 1-3
- Where
- 18 sites in United States, Estonia and 6 more
- Volunteers
- 48 people
- Sponsor
- Pfizer
Haemophilus Influenzae Type b
Safety and Immunogenicity of a Monovalent Conjugated Vaccine Against Haemophilus Influenzae Type b
This study will investigate safety and immunogenicity of a monovalent conjugated vaccine against Haemophilus influenzae type b in healthy children aged 2 to 4 months in China.
- Trial name
- NCT00808392
- Testing
- Haemophilus influenzae type b vaccine, Commercial Haemophilus influenzae type b vaccine
- Where
- 2 sites in China
- Volunteers
- 916 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Meningococcal Disease
Persistence of Immunogenicity of MenACWY Conjugate Vaccine 5 Years After Childhood Vaccination, and Immune Response to a Booster Dose
In this extension study, V59P20E1, the sponsor was planning to assess 5-year antibody persistence in subjects who received one or two doses of MenACWY conjugate vaccine at 2 to 10 years of age, and to evaluate response to a…
- Trial name
- NCT01823536
- Testing
- Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine
- Where
- 16 sites in United States, Ukraine
- Volunteers
- 465 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Meningococcal Disease, Meningococcal Meningitis
Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered as Booster Dose at 12, 18 or 24 Months of Age in Toddlers (12-24 Months) Primed With a Three-Dose Immunization Series as Infants in Study V72P12
This extension study V72P12E1 will investigate the safety, tolerability and immunogenicity of a fourth (booster) dose of rMenB+OMV NZ at 12, 18 and 24 months of age in subjects previously primed with rMenB+OMV NZ according to two…
- Trial name
- NCT00944034
- Testing
- rMenB+OMV NZ with routine vaccinations, rMenB+OMV NZ, two doses of rMenB+OMV NZ
- Where
- 72 sites in Belgium, Czechia and 4 more
- Volunteers
- 1,588 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Cystic Fibrosis
Registry to Monitor the Susceptibility to Aztreonam of Pseudomonas Aeruginosa Isolates From Cystic Fibrosis Patients
This is a prospective, longitudinal, 5-year study that will enroll participants from the existing Cystic Fibrosis Foundation (CFF) patient registry.
- Trial name
- AIR-CF5 (NCT01375036)
- Where
- 31 sites in United States
- Volunteers
- 510 people
- Sponsor
- Gilead Sciences
Diphtheria, Tetanus
Study to Compare Pediacel® to Infanrix®-IPV+Hib When Both Are Co-Administered With Prevenar® in Infants and Toddlers
The purpose of this study is to evaluate safety and immunogenicity of Pediacel® in infants and toddlers when given at 2,3,4 and 12-18 months of age.
- Conditions
- Diphtheria, Tetanus, Pertussis, Poliomyelitis
- Trial name
- NCT00343421
- Testing
- PEDIACEL® and Prevenar®, Infanrix®-IPV+Hib and Prevenar®
- Where
- 2 sites in France, Poland
- Volunteers
- 588 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Cystic Fibrosis, Pseudomonas Aeruginosa
Safety of AZLI in Children With Cystic Fibrosis (CF) and Chronic Pseudomonas Aeruginosa in the Lower Airways
This was an open-label, multicenter study in children ≤ 12 years of age with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa (PA) infection in the lower airways using three 28-day courses of Aztreonam for Inhalation…
- Trial name
- PALS (NCT01404234)
- Testing
- AZLI
- Where
- 29 sites in United States, France and 4 more
- Volunteers
- 61 people
- Sponsor
- Gilead Sciences
Epidemic Meningitis
A Clinical Trial of the ACYW135 Group Meningococcal Polysaccharide-Conjugated Vaccine (CRM197 Vector)
This study included 180 trial participants who had previously taken part in the Phase IIIb clinical trial of the ACYW135 group meningococcal polysaccharide-conjugated vaccine (CRM197 carrier) for children aged 4-6 years (Protocol…
- Trial name
- NCT07743411
- Testing
- Previously vaccinated with MCV4 (CanSino), Previously vaccinated with MPSV4 (LvZhu)
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- CanSino Biologics Inc.