Clinical trials: Gram-Negative Bacterial Infections
Cystic Fibrosis, Pseudomonas Aeruginosa
Ph 1/2 Study Evaluating Safety and Tolerability of Inhaled AP-PA02 in Subjects With Chronic Pseudomonas Aeruginosa Lung Infections and Cystic Fibrosis
Phase 1b/2a, double-blind, randomized, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability and phage recovery profile of AP-PA02 multi-bacteriophage therapeutic candidate administered…
- Conditions
- Cystic Fibrosis, Pseudomonas Aeruginosa, Pseudomonas, Lung Infection
- Trial name
- SWARM-Pa (NCT04596319)
- Testing
- AP-PA02
- Where
- 20 sites in United States
- Volunteers
- 29 people
- Sponsor
- Armata Pharmaceuticals, Inc.
Healthy Volunteers (Meningococcal Infection)
Study to Assess the Safety and Immunogenicity of a Single Dose of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) in Older Adults in Turkey and Lebanon
The primary objectives of this study are: To describe the antibody response to meningococcal serogroups A, C, W, and Y measured by serum bactericidal assay using baby rabbit complement (rSBA) before and after a single dose of…
- Trial name
- MEQ00063 (NCT03869866)
- Testing
- Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine MenACYW conjugate vaccine
- Where
- 3 sites in Lebanon, Turkey (Türkiye)
- Volunteers
- 290 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Diphtheria, Tetanus
A Study of DTaP-IPV-Hep B-PRP-T Vaccine Given With Prevenar™ and Rotarix™ in Healthy Latin American Infants
The purpose of this study is to generate immunogenicity and safety data of an investigational hexavalent DTaP-IPV-Hep B-PRP-T vaccine compared to a control vaccine, Infanrix hexa™ when given along with Prevenar™ and Rotarix™…
- Conditions
- Diphtheria, Tetanus, Whooping Cough, Hepatitis B
- Trial name
- NCT01177722
- Testing
- DTaP-IPV-Hep B-PRP-T Vaccine, DTaP-Hep B-IPV vaccine
- Where
- 2 sites in Colombia, Costa Rica
- Volunteers
- 1,375 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Infections, Meningococcal
Trial to Assess Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Meningococcal ABCWY Vaccine as Compared to Meningococcal B Vaccine in Adolescents
The main purposes for conducting the study are firstly to assess immunological non-inferiority of the MenABCWY vaccine, administered according to 0, 2 month schedule to healthy adolescents 10 to 18 years of age, to those of the…
- Trial name
- NCT02212457
- Testing
- Bexsero, Havrix, MenABCWY
- Where
- 32 sites in United States, Finland and 1 more
- Volunteers
- 1,063 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Haemophilus Influenzae Type b, Neisseria Meningitidis
Primary & Booster Immunogenicity Study of GSK Biologicals' Hib-MenC Versus a Licensed Men-C Vaccine
The purpose of this study is to demonstrate the non-inferiority of the candidate Hib-MenC conjugate vaccine co-administered with Infanrix™-IPV versus a licensed meningococcal serogroup C vaccine co-administered with Pediacel™…
- Trial name
- NCT00258700
- Testing
- Haemophilus influenzae type b- and meningococcal (vaccine)
- Where
- 10 sites in Poland, United Kingdom
- Volunteers
- 478 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B, Diphtheria
Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly
This study will assess the immunogenicity of GlaxoSmithKline (GSK) Biologicals' (formerly SmithKline Beecham Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared to the separate administration of DTPa-HBV-IPV…
- Conditions
- Hepatitis B, Diphtheria, Haemophilus Influenzae Type b (Hib), Poliomyelitis
- Trial name
- NCT01457495
- Testing
- DTPa-HBV-IPV/Hib (Infanrix-hexa™), DTPa-IPV/Hib (Infanrix-IPV/Hib™), HBV (Engerix™-B)
- Volunteers
- 312 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pertussis, Pertussis Vaccines
A Study to Determine the Seroprevalence of Bordetella Pertussis in Adults in Hungary
The purpose of this study is to perform an epidemiological survey of the adult population in Hungary to calculate the seroprevalence of pertussis.
- Trial name
- NCT02014519
- Testing
- Blood sampling, Data collection
- Where
- 5 sites in Hungary
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Non-Cystic Fibrosis Bronchiectasis
Safety and Efficacy Study of Ciprofloxacin for Inhalation in Patients With Non-Cystic Fibrosis Bronchiectasis "ORBIT-1"
The purpose of this study is to evaluate the safety and efficacy of Ciprofloxacin for Inhalation in the treatment of patients with non-cystic fibrosis (CF) bronchiectasis.
- Trial name
- NCT00889967
- Testing
- Ciprofloxacin for Inhalation
- Where
- 37 sites in United States, Canada and 2 more
- Volunteers
- 95 people
- Sponsor
- Aradigm Corporation
Suspected or Documented Gram-negative Bacterial Infection
Safety, Tolerability, Efficacy and Pharmacokinetics of Imipenem/Cilastatin/Relebactam (MK-7655A) in Pediatric Participants With Gram-negative Bacterial Infection (MK-7655A-021)
The primary purpose of this study is to evaluate the safety and tolerability of imipenem/cilastatin/relebactam (IMI/REL) in participants from birth to less than 18 years of age with confirmed or suspected gram-negative bacterial…
- Trial name
- NCT03969901
- Testing
- IMI/REL, Active Control, Oral Switch
- Where
- 67 sites in United States, Bulgaria and 16 more
- Volunteers
- 115 people
- Sponsor
- Merck Sharp & Dohme LLC
Gram-negative Bacterial Infections, Hospital Acquired Bacterial Pneumonia (HABP)
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Participants
The primary objectives of this study are to assess the safety, tolerability, and pharmacokinetics (PK) of cefiderocol after single-dose administration in hospitalized pediatric participants 3 months to < 12 years of age with…
- Conditions
- Gram-negative Bacterial Infections, Hospital Acquired Bacterial Pneumonia (HABP), Complicated Urinary Tract Infection (cUTI), Ventilator Associated Bacterial Pneumonia (VABP)
- Trial name
- NCT04215991
- Testing
- Cefiderocol, Standard of Care
- Where
- 25 sites in United States, Australia and 8 more
- Volunteers
- 91 people
- Sponsor
- Shionogi
Pulmonary Infections, Pseudomonas Aeruginosa
Second Open Label Extension to Bridging Study CTBM100C2303
This was an open-label, single arm (uncontrolled) study in participants suffering from cystic fibrosis, who have completed their study participation in CTBM100C2303 and extension study one CTBM100C2303E1 (all visits), who were…
- Trial name
- NCT01069705
- Testing
- Tobramycin inhalation powder
- Where
- 17 sites in Bulgaria, Estonia and 5 more
- Volunteers
- 49 people
- Sponsor
- Novartis Pharmaceuticals
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
Diphtheria
A Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK)'s Infanrix Hexa Vaccine (DTPa-HBV-IPV/Hib) Versus MCM Vaccine BV's Vaxelis Vaccine (DTaP5-HBV-IPV-Hib) in Healthy Infants and Toddlers
The purpose of this study was to assess the safety and immunogenicity of GSK's combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b conjugate vaccine…
- Trial name
- NCT04535037
- Testing
- DTPa-HBV-IPV/Hib, DTaP5-HBV-IPV-Hib, Pneumococcal 13-valent conjugate vaccine
- Where
- 20 sites in Germany, Italy and 1 more
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Haemophilus Influenzae Type B, Hepatitis B
Study of Modified Process Hib/Hep B Vaccine in Infants (V121-019)(COMPLETED)
To determine if there is an improvement in the immune response to HBsAg (hepatitis B virus) in healthy infants using a modified process in a combination Haemophilus Influenzae, type b/Hepatitis B vaccine and a currently licensed…
- Trial name
- NCT00441012
- Testing
- Comparator: Modified Process Vaccine, Comparator: COMVAX™
- Volunteers
- 546 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Tetanus, Diphtheria
Study of DTap-IPV Compared to DAPTACEL® and IPOL® as the 5th Dose in Children 4 to 6 Years of Age
The study was designed to compare the safety and immunogenicity of DTap-IPV with DAPTACEL® + IPOL® as the 5th dose booster in children ≥ 4 to < 7 years of age in the US and Puerto Rico who were previously vaccinated with…
- Conditions
- Tetanus, Diphtheria, Pertussis, Measles
- Trial name
- NCT01346293
- Testing
- Diphtheria and Tetanus Toxoids and Acellular Pertussis + Measles, Mumps, Rubella + Varicella Virus, Diphtheria and Tetanus Toxoids and Acellular Pertussis + Poliovirus + MMR + Varicella Virus
- Where
- 72 sites in United States, Puerto Rico
- Volunteers
- 3,372 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Plague
One Year Study to Evaluate Three Different Adjuvanted Doses of the Recombinant Plague Vaccine (rF1 and rV Antigens)
One hundred and five subjects will be recruited into three groups. Each subject will receive two doses of recombinant plague vaccine at one of three dose levels (rF1 and rV recombinant antigen proteins).
- Trial name
- NCT00246467
- Testing
- Alhydrogel, rF1 and rV protein antigens
- Where
- 10 sites in United States, United Kingdom
- Volunteers
- 123 people, healthy volunteers welcome
- Sponsor
- PharmAthene UK Limited
Meningococcal Meningitis
A Clinical Trial of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in 18-59 Year Olds
This is a randomized, observer-blind, peer-controlled study. There will be 2 treatment groups, screened subjects were given study numbers in the order of enrollment and randomly assigned to the test and control groups in a 1:1…
- Trial name
- NCT06226714
- Testing
- MCV4, MPSV4
- Where
- 3 sites in China
- Volunteers
- 840 people, healthy volunteers welcome
- Sponsor
- CanSino Biologics Inc.
Amyotrophic Lateral Sclerosis (ALS), Angina, Stable
Quest to Analyze One Thousand Humans Meditating
This study will be focused on assessing the molecular, physiological, and emotional correlates of an intensive meditation experience in the context of a retreat setting in a large 2000 plus-person cohort comprised of healthy and…
- Conditions
- Amyotrophic Lateral Sclerosis (ALS), Angina, Stable, Anxiety, Asthma
- Trial name
- QUANTUM (NCT06583395)
- Testing
- Advanced multi-component meditation practice
- Where
- United States
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- Tobias Moeller-Bertram
Hepatitis B, Whole Cell Pertussis
Assess Immunogenicity, Reactogenicity, Safety of a Booster of GSK Biologicals DTPw-HBV/Hib Kft Compared to DTPw-HBV/Hib
This booster study will assess the immunogenicity, reactogenicity and safety of a booster dose of GSK Biologicals' DTPw-HBV/Hib Kft.
- Conditions
- Hepatitis B, Whole Cell Pertussis, Tetanus, Haemophilus Influenzae Type b
- Trial name
- NCT00332566
- Testing
- DTPw-HBV/Hib Kft vaccine GSK323527A, Tritanrix™-HepB/Hiberix™
- Where
- 2 sites in Argentina, Nicaragua
- Volunteers
- 148 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pseudomonas Infections
Pharmacokinetic Evaluation of an 8 -Week Treatment With Inhaled Tobramycin
This study is designed to provide data about the pharmacokinetics (PK), safety and tolerability of two continuous treatment regimes of tobramycin nebulized solution delivered via a 'soft mist' nebulizer in Cystic Fibrosis (CF)…
- Trial name
- NCT00634192
- Testing
- tobramycin
- Where
- 8 sites in Germany
- Volunteers
- 50 people
- Sponsor
- Novartis