Clinical trials: Gram-negative Bacterial Infection
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
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
Helicobacter Pylori Infection
Safety and Efficacy Study of a Non-antibiotic Treatment for the Eradication of Helicobacter Pylori
At present, triple therapy is recommended by various guidelines for the treatment of Helicobacter pylori (H.pylori) infection. Recent studies have shown increasing resistance of H.pylori to commonly used antibiotics used in…
- Trial name
- NCT01109381
- Testing
- GT08
- Where
- Singapore
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Synergy Pharmaceuticals Pte. Ltd.
Gram-negative Bacterial Infections, Bloodstream Infections (BSI)
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants
The primary objectives of this study are: To assess the safety and tolerability of cefiderocol after single-dose administration in hospitalized paediatric participants 3 months to < 18 years of age with suspected or confirmed…
- Conditions
- Gram-negative Bacterial Infections, Bloodstream Infections (BSI), Complicated Intra-abdominal Infection (cIAI), Hospital Acquired Pneumonia (HAP)
- Trial name
- NCT04335539
- Testing
- Cefiderocol, Standard of Care
- Where
- 23 sites in Belgium, Estonia and 7 more
- Volunteers
- 53 people
- Sponsor
- Shionogi
Meningitis, Epiglottitis, Pneumonia, Arthritis Caused by Haemophilus Influenzae Type b
Persistency Study After Hib-CRM (Cross-Reacting Material)197 or Hib-TT (Tetanus Toxoid) Vaccines in Chinese Children
Evaluate the persistency of immune response against Haemophilus influenzae type b by assessing anti-PRP antibody levels in children vaccinated with either Hib-CRM197 or Hib-TT booster vaccine approximately 4 years before.
- Trial name
- NCT02139228
- Testing
- Hib-CRM197, Hib-TT
- Where
- China
- Volunteers
- 426 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Meningitis, Meningococcal
Study to Assess Potential Immune Interference When GlaxoSmithKline (GSK) Biologicals' MenABCWY Vaccine is Administered to Healthy Subjects Aged 10-25 Years
The purpose of the current study is to evaluate whether there is immune interference when MenABCWY [consisting of MenACWY lyophilized component and rMenB+OMV NZ (Bexsero) liquid component] is administered to healthy adolescents…
- Trial name
- NCT03587207
- Testing
- MenABCWY vaccine, rMenB+OMV NZ (Bexsero) vaccine, MenACWY (Menveo) vaccine
- Where
- Czechia
- Volunteers
- 520 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pressure Ulcer
Phage Therapy for the Prevention and Treatment of Pressure Ulcers.
This study will evaluate a topical bacteriophage therapy product (BACTELIDE) as an adjunct to standard therapy for the prevention and treatment of pressure ulcers colonized with S. aureus, P. aeruginosa, or K. pneumoniae species.
- Trial name
- NCT04815798
- Testing
- Bacteriophage-loaded Microcapsule Spray, Standard of Care
- Volunteers
- 69 people
- Sponsor
- Precisio Biotix Therapeutics, Inc.
Diphtheria, Tetanus
Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent (DTwP-Hib-Hep B) Vaccine in Infants 6-8 Weeks of Age
This study will evaluate immunogenicity, safety and tolerability of fully liquid pentavalent vaccine (DTwP-Hib-HepB Vaccine) in infants 6-8 weeks of age.
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT01470287
- Testing
- DTwP-HepB-Hib Vaccine
- Where
- 3 sites in India
- Volunteers
- 175 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Plague, Plague, Bubonic
Yersinia Pestis Lateral Flow Immunoassay for Blood Samples
Plague is a deadly but highly treatable disease caused by the bacterium Y. pestis. Due to the historical development of Y. pestis as a bioweapon by several nation states, it is listed by the US as a potential bioweapon that could…
- Conditions
- Plague, Plague, Bubonic, Plague, Pneumonic, Yersinia Pestis Plague
- Trial name
- SMARTPRT (NCT04688996)
- Testing
- Lateral Flow Assay for Pathogens of the Plague
- Where
- 2 sites in United States, Madagascar
- Volunteers
- 500 people
- Sponsor
- Brimrose Technology Corporation
Meningococcal Meningitis, Measles
A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy Toddlers
This is a Phase III, modified single-blind, randomized, parallel-group, multicenter, comparative trial in the United States designed to evaluate the immunogenicity and safety of two doses of Menactra vaccine administered alone…
- Conditions
- Meningococcal Meningitis, Measles, Mumps, Rubella
- Trial name
- NCT00384397
- Testing
- Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine, Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
- Where
- 39 sites in United States
- Volunteers
- 1,128 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Bacterial Skin Diseases
Multicenter Study of Antimicrobial Resistance of Gram-positive and Gram-negative Clinical Strains to Ceftaroline and Other Antimicrobials in Russia
Approximately 3,000 of clinically significant isolates of different species from respective respective sources in geographically distinct Russian cities will be collected and tested on ceftaroline and other antimicrobials.
- Trial name
- CERBERUS (NCT01700842)
- Where
- 2 sites in Russia
- Volunteers
- 3,000 people
- Sponsor
- AstraZeneca
Diphtheria, Tetanus
Immunogenicity and Safety of Pentaxim as 3 Doses Primary Vaccination Followed by a Booster Dose at 18 Months
As per request by the Heath Authorities, the present clinical study will assess the immunogenicity and safety of sanofi pasteur's DTacP-IPV// PRP~T combined vaccine (PENTAXIM™) as a three-dose primary vaccination at 2, 3, and 4…
- Conditions
- Diphtheria, Tetanus, Haemophilus Influenzae Type b, Pertussis
- Trial name
- NCT00453570
- Testing
- Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib, Diphtheria, Tetanus, & Acellular Pertussis Combined, Absorbed
- Where
- China
- Volunteers
- 792 people, healthy volunteers welcome
- Sponsor
- Sanofi
Haemophilus Influenzae Type b, Acellular Pertussis
Safety Study of GSK Biologicals' DTPa-IPV/Hib (Infanrix™-IPV/Hib)
This study will evaluate the safety and reactogenicity of Infanrix-IPV/Hib given as a three-dose primary vaccination course to healthy infants at 2-3-4 or 3-4-5 months of age.
- Conditions
- Haemophilus Influenzae Type b, Acellular Pertussis, Diphtheria, Tetanus
- Trial name
- NCT00964028
- Testing
- Infanrix™-IPV/Hib
- Where
- China
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Shigellosis
Evaluate a New Shigella Sonnei Vaccine Administered Either by Intradermal, Intranasal or Intramuscular Route in Healthy Adults
This Phase 1 clinical trial is aimed to evaluate the safety and immunogenicity of 3 doses of a candidate vaccine against Shigella sonnei (1790GAHB vaccine) when administered at different dosages by different routes…
- Trial name
- NCT02034500
- Testing
- S. sonnei 1790GAHB
- Where
- United Kingdom
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- GSK Vaccines Institute For Global Health S.r.l.
Urogential Chlamydia Trachomatis Infection
Treatment of Chlamydia Infection Comparing WC2031 Tablets With Vibramycin
Evaluate the clinical efficacy and safety of WC2031 200 mg tablets taken orally once a day for 7 days versus Vibramycin (doxycycline) 100 mg capsules taken orally twice a day for 7 days, for the treatment of uncomplicated…
- Trial name
- NCT01113931
- Testing
- Doxycyline Hyclate tablet, Vibramycin (doxycyline hyclate) capsule
- Where
- 43 sites in United States
- Volunteers
- 495 people
- Sponsor
- Warner Chilcott
Meningococcal Disease
A Study to Evaluate the Safety and Immunogenicity of 4 Doses of MenACWY Conjugate Vaccine, Administered Concomitantly With Routine Vaccines, Among Infants Aged 2 Months
This Phase 3 study is designed to demonstrate the safety and immunogenicity of MenACWY and non-interference of concomitant routine vaccines by MenACWY in an infant age group.
- Trial name
- NCT01000311
- Testing
- MenACWY-CRM, DTaP-IPV/Hib, HBV
- Where
- 46 sites in United States, Australia and 1 more
- Volunteers
- 529 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Infections, Meningococcal
Comparison of GSK134612 in Subjects Previously Vaccinated Against Meningococcal Disease Versus Non-vaccinated Subjects
In this study, subjects who were vaccinated with a meningococcal polysaccharide vaccine in a previous study (whose objectives \& outcome measures are presented in a separate protocol posting with NCT number = 00227422) will be…
- Trial name
- NCT00661557
- Testing
- Meningococcal vaccine GSK134612 (Nimenrix)
- Where
- Lebanon
- Volunteers
- 271 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Tetanus and Pertussis
Post Authorisation Safety Study of Triaxis as a 5th Dose in 4-6 Year Old Spanish Children
Primary objective: This is a descriptive study and the primary objective is to determine the incidence of injection site and systemic adverse events after Triaxis administration as a 5th dose of tetanus, diphtheria and acellular…
- Trial name
- NCT01583049
- Where
- 22 sites in Spain
- Volunteers
- 556 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Meningococcal Disease
Persistence Of Antibody Responses Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine
The primary purpose of this study is to evaluate the persistence of bactericidal antibodies in children of approximately 22 to 45 months of age previously enrolled in the V59P22 study (NCT00667602) who received Novartis MenACWY…
- Trial name
- NCT01345721
- Testing
- MenACWY-CRM
- Where
- 11 sites in Germany
- Volunteers
- 205 people
- Sponsor
- Novartis Vaccines
Infections, Meningococcal
Study to Evaluate Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK 134612
Subjects were previously vaccinated at 11 to 17 years of age. This extension phase starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension phase.
- Trial name
- NCT00974363
- Testing
- Blood Sampling
- Where
- 5 sites in India, Philippines
- Volunteers
- 697 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline