Clinical trials: Gram-Negative Bacterial Infections
Chlamydia Trachomatis Infection, Neisseria Gonorrheae Infection
NeuMoDx PrEDiCTiNG Study Evaluation Plan
This investigational study will be conducted to evaluate the performance of the NeuMoDx™ CT/NG Assay on the NeuMoDx™ 288 Molecular System and NeuMoDx™ 96 Molecular System (collectively referred to as NeuMoDx™ CT/NG Assay test…
- Trial name
- NCT03970850
- Testing
- NeuMoDx CT/NG Assay, FDA-cleared NAATs
- Where
- 15 sites in United States
- Volunteers
- 4,017 people, healthy volunteers welcome
- Sponsor
- NeuMoDx Molecular, Inc.
Cystic Fibrosis
Study to Evaluate the Effect of KB001-A on Time-to-Need for Antibiotic Treatment
The purpose of this study is to confirm and extend the Phase 1-2 KB001 findings of an airway anti-inflammatory effect in CF individuals with chronic Pseudomonas aeruginosa (Pa) airway infection.
- Trial name
- KB001-A (NCT01695343)
- Testing
- KB001-A
- Where
- 67 sites in United States, Australia and 2 more
- Volunteers
- 182 people
- Sponsor
- Humanigen, Inc.
Infections, Streptococcal
Prophylactic Antipyretic Treatment in Children Receiving Booster Dose of Pneumococcal Conjugate Vaccine GSK1024850A
The purpose of this trial is to assess if the rate of febrile reactions following the co-administration of a booster dose of pneumococcal conjugate vaccines with standard infant vaccines is lowered when paracetamol is given…
- Trial name
- NCT00496015
- Testing
- Pneumococcal conjugate vaccine GSK1024850A., Infanrix hexa., Meningococcal vaccine GSK134612.
- Where
- 10 sites in Czechia
- Volunteers
- 750 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Acellular Pertussis
Study to Analyze the Risk Factors Associated With Pertussis/Whooping Cough Infection Among Infants
This study aims to estimate the risk factors associated with pertussis/whopping cough infection among infants less than one year of age in a United States (U.S.) commercially insured population.
- Conditions
- Diphtheria, Acellular Pertussis, Tetanus
- Trial name
- NCT01890850
- Testing
- Retrospective database study using administrative claims data
- Volunteers
- 1 people
- Sponsor
- GlaxoSmithKline
Meningococcal Disease, Meningococcal Meningitis
Safety, Tolerability and Immunogenicity of a Third Dose of One of Four Different Formulations of rMenB + MenACWY Combination Vaccine in Adolescents Who Previously Received the Same Study Vaccines
This study will evaluate safety, tolerability, and immunogenicity of a booster dose of a meningococcal vaccine formulation in adolescents.
- Trial name
- NCT01367158
- Testing
- Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine, Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Tdap
- Where
- 7 sites in Chile, Colombia and 1 more
- Volunteers
- 440 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Helicobacter Infections, Bacterial Infections
Study of the Safety and Effectiveness of Rabeprazole in Treatment of Helicobacter Pylori Infection in Adults.
The purpose of the study is to confirm the safety and effectiveness of rabeprazole in the treatment of adult patients with Helicobacter pylori (H. pylori) infection in routine clinical practice.
- Trial name
- NCT00216450
- Testing
- rabeprazole sodium
- Volunteers
- 80 people
- Sponsor
- Janssen Cilag Pharmaceutica S.A.C.I., Greece
Meningococcal Disease
Safety of One Dose of Meningococcal ACWY Conjugate Vaccine in Subjects 2 Years of Age and Older
A multicenter, single arm, postmarketing surveillance study. This study is a postlicensure requirement of the Philippine Food and Drug Administration (FDA) to provide continued safety evaluation of MenACWY-CRM in Philippine…
- Trial name
- NCT01705379
- Testing
- Novartis Meningococcal ACWY Conjugate Vaccine
- Volunteers
- healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Meningococcal Meningitis, Meningococcal Infections
Safety Study of Group A, C, Y & W-135 Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine for Meningitis
The purpose of this study is to evaluate the safety of a new conjugate vaccine, NmVac4-A/C/Y/W-135-DT, compared to the safety of a similar, licensed meningococcal A/C/Y/W-135-DT conjugate vaccine.
- Trial name
- NCT01482052
- Testing
- meningococcal meningitis conjugate vaccine, quadrivalent
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- JN-International Medical Corporation
Diphtheria, Tetanus
DTaP-IPV-Hep B-PRP~T Combined Vaccine Versus DTaP-IPV//PRP~T Combined Vaccine + Hep B Vaccine in Hep B Primed Infants
The aim of this study is to evaluate the immunogenicity and safety of a novel DTaP-IPV-Hep B-PRP~T fully liquid combined hexavalent vaccine (study vaccine) administered at 2, 4, and 6 months of age compared to Sanofi Pasteur's…
- Conditions
- Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b Infection
- Trial name
- NCT02094833
- Testing
- DTaP-IPV-Hep B-PRP~T combined vaccine, DTaP-IPV//PRP~T and Hepatitis B vaccine
- Where
- 16 sites in South Korea
- Volunteers
- 310 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Bordetella Pertussis, Whooping Cough
Pertussis Immunization Programs in Low Income Countries
Due to waning of infectious as well as vaccine immunity and lack of vaccination boosters, a large number of adolescents and adults are no longer immunized against Bordetella pertussis, the agent of whooping cough and consequently…
- Trial name
- PERILIC (NCT02983487)
- Testing
- Nasopharyngeal sampling, Blood Sampling
- Where
- 3 sites in Cambodia, Madagascar and 1 more
- Volunteers
- 3,587 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
Meningococcal Meningitis, Meningococcal Infections
Persistence of Protective Antibody Titers 12-24 Months After NmVac4-A/C/Y/W-135-DT Vaccination: Follow Up Study
To determine the persistence of protective antibody levels for subjects who seroconverted after vaccination with NmVac4-A/C/Y/W-135-DT™ Participants in trial # JN-NM-002, who seroconverted for serogroups A and C will be contacted…
- Trial name
- NCT02500511
- Testing
- NmVac4-A/C/Y/W-135-DT™
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- JN-International Medical Corporation
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
Meningococcal Disease, Meningococcal Meningitis
Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years
Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years
- Trial name
- NCT00329901
- Testing
- Meningococcal ACWY conjugate vaccine (MenACWY-CRM), Combined tetanus, reduced diphtheria and acellular pertussis vaccine (Tdap)
- Where
- 14 sites in Italy
- Volunteers
- 1,072 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Chlamydia Trachomatis Infection
Safety and Efficacy Study of Rifalazil for the Treatment of Chlamydia Trachomatis Infection in Women
This study will test the safety and effectiveness of an investigational antibiotic drug, rifalazil for the treatment of uncomplicated genital Chlamydia trachomatis infection.
- Trial name
- NCT01631201
- Testing
- Rifalazil 25 milligram, Azithromycin 1 gram
- Where
- 5 sites in United States
- Volunteers
- 82 people
- Sponsor
- ActivBiotics Pharma, LLC
Cystic Fibrosis
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis (CF) Patients With Pseudomonas Aeruginosa (PA)
The purpose of this study was to evaluate the safety and efficacy of multiple courses of AZLI in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).
- Trial name
- AIR-CF3 (NCT00128492)
- Testing
- AZLI 75 mg two times a day (BID)/ three times a day (TID)
- Where
- 65 sites in United States, Australia and 2 more
- Volunteers
- 274 people
- Sponsor
- Gilead Sciences
Lyme Disease
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1982 to Prevent Lyme Disease in Healthy Participants (18 to 70 Years of Age)
This clinical study will evaluate the safety, reactogenicity, and immunogenicity of monovalent mRNA-1982, a messenger ribonucleic acid (mRNA) vaccine to prevent Lyme disease in healthy adults aged 18 to 70 years old.
- Trial name
- NCT07561294
- Testing
- mRNA-1982
- Where
- 8 sites in Canada
- Volunteers
- 366 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Diagnosis, Gonorrhea
Susceptibility Testing In Neisseria Gonorrhoeae (STING) Study, Assessing the Performance of a New Rapid Test for Gonorrhoea Antibiotic Resistance, in a Cohort of 100 Culture Positive Neisseria Gonorrhoeae Infections
This study aims to validate a novel antibiotic susceptibility test (InSignia) for gonorrhoea in patient clinical samples. The hypothesis is that the InSignia test will be able to detect transcriptional responses after incubation…
- Conditions
- Diagnosis, Gonorrhea, Resistance Bacterial
- Trial name
- STING (NCT06352554)
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- SpeeDx Pty Ltd
Dysentery, Bacillary
A Study to Evaluate Safety and Immunogenicity of 1 Booster Dose of 1790GAHB Vaccine in Healthy Adults Primed With 3 Doses of 1790GAHB Vaccine in Study H03_01TP Compared to 1 Vaccination of 1790GAHB in Either Subjects Who Received Placebo in the Same Study or naïve Subjects Not Part of H03_01TP Study
GVGH Shigella Sonnei 1970GAHB is a vaccine aimed at preventing the disease caused by Shigella sonnei. A post-hoc analysis of subjects who participated in the parent study showed significantly different responses in subjects with…
- Trial name
- NCT03089879
- Testing
- GVGH Shigella sonnei 1790GAHB vaccine
- Where
- France
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Meningococcal Infection
Observational, Passive Surveillance Program to Collect Information on Women and Their Offspring Exposed to MenQuadfi® During Pregnancy, in United States (US)
Primary Objective: To assess maternal, obstetrical, pregnancy, and neonatal and infant outcomes among women vaccinated with MenQuadfi® during pregnancy or in the 30 days preceding their Last Menstrual Period (LMP).
- Trial name
- NCT04843111
- Testing
- Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
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