Clinical trials: Gram-Negative Bacterial Infections
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
Cystic Fibrosis
Retrospective Observational Study to Compare Cystic Fibrosis Patients in Two Decades Before and After 2000
The purpose of this study is to describe two cohorts of cystic fibrosis patients treated in 2 different decades in terms of FEV1 (Forced Expiratory Volume in one second) maintenance.
- Trial name
- MAESTRALE (NCT01651455)
- Where
- Italy
- Volunteers
- 92 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Neisseria Meningitidis, Haemophilus Influenzae Type b
Immunogenicity, Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Hib-MenCY-TT (MenHibrix®) Vaccine Compared to Merck & Co, Inc. PedvaxHIB Vaccine in Healthy Infants and Toddlers 12 to 15 Months of Age
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals' Hib-MenCY-TT (MenHibrix®) vaccine co-administered with Rotarix, Prevnar 13 and Havrix as compared to PedvaxHIB…
- Trial name
- NCT01978093
- Testing
- Hib-MenCY-TT (MenHibrix®), Pediarix®, Rotarix®
- Where
- 26 sites in United States
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Meningococcal Disease
Safety, Tolerability and Immunogenicity of Two Different Formulations of Meningococcal B Recombinant Vaccine, When Administered to Healthy Infants
To explore safety, Tolerability and immunogenicity of two formulations of a Meningococcal B Recombinant Vaccine when administered to healthy infants.
- Trial name
- NCT00433914
- Testing
- rMenB, rMenB+OMV
- Where
- United Kingdom
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Diphtheria, Tetanus
Assessment of the Immunogenicity and Safety of PENTAXIM™ in Philippines
The present clinical study will assess the immunogenicity and reactogenicity of the subsequent administration of Aventis Pasteur's DTacP-IPV//PRP~T combined vaccine (PENTAVAC™/PENTAXIM), as a three-dose primary vaccination in 6…
- Conditions
- Diphtheria, Tetanus, Polio, Pertussis
- Trial name
- NCT00254917
- Testing
- Diphteria, Tetanus, Polio, Acellular Pertussis, Hib vaccine
- Where
- Philippines
- Volunteers
- 387 people, healthy volunteers welcome
- Sponsor
- Sanofi
Healthy Volunteers (Meningococcal Infection)
Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
The primary objective of this study is to demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups A, C, Y, and W following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses…
- Trial name
- NCT03691610
- 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, Meningococcal Polysaccharide (serogroups A,C,Y and W-135) Diphtheria Toxoid Conjugate Vaccine
- Where
- 47 sites in United States, Puerto Rico
- Volunteers
- 950 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Bell's Palsy, Ramsay Hunt Syndrome
Safety and Effectiveness of the BlinkER System in Participants With Facial Nerve Palsy
Prospective, single-arm, multicenter, single-masked, pivotal study to Evaluate the Safety and Effectiveness of the Blinker system in Participants with Facial Nerve Palsy.
- Conditions
- Bell's Palsy, Ramsay Hunt Syndrome, Lyme Disease, Facial Palsy
- Trial name
- Paralysis (NCT06542289)
- Testing
- BlinkER device.
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Neurotrigger Ltd
Proven or Suspected Gram-negative Bacterial Infection, Peri-operative Prophylaxis
Pharmacokinetic and Safety Study of Ceftolozane/Tazobactam in Pediatric Participants Receiving Antibiotic Therapy for Proven or Suspected Gram-negative Infection or for Peri-operative Prophylaxis (MK-7625A-010)
The purpose of this study was to assess the pharmacokinetics, safety, and tolerability of a single intravenous dose of ceftolozane/tazobactam (MK-7625A) in pediatric participants.
- Trial name
- NCT02266706
- Testing
- Ceftolozane/Tazobactam 1000/500 mg, Ceftolozane/Tazobactam 30/15 mg/kg, Ceftolozane/Tazobactam 20/10 mg/kg
- Volunteers
- 43 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Diphtheria, Tetanus
Study of an Investigational Vaccine in Healthy Infants in Taiwan (V441-001)(COMPLETED)
The purpose of this study is to evaluate the safety, tolerability, and immune response of an investigational vaccine being evaluated to reduce the incidence of diphtheria, pertussis, tetanus, hepatitis B, poliomyelitis, and…
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT00092469
- Testing
- V441, diptheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant), & Haemophilus influenza type b conjugate vaccine
- Volunteers
- 151 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Acellular Pertussis, Hepatitis B
Safety and Immunogenicity of a Booster Dose of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744)
The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the booster vaccine dose of 2 new formulations of DTPa-HBV-IPV/Hib administered between 12 and 15 months of age, and the immune persistence…
- Conditions
- Acellular Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Tetanus
- Trial name
- NCT01453998
- Testing
- Infanrix hexa, Prevenar 13, GSK217744
- Where
- 16 sites in Dominican Republic, Finland
- Volunteers
- 657 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Meningococcal Meningitis, Meningococcal Infections
Safety and Immunogenicity in Dose-Ranging and Formulation-Finding Meningococcal B (MenB) Vaccine Study in 2-month-old Infants
This study is aimed at assessing the safety and immunogenicity of different doses and formulations of a new Novartis Meningococcal B Recombinant Vaccine.
- Trial name
- NCT00937521
- Testing
- Meningococcal B vaccine, Control, Meningococcal B vaccine with antipyretic
- Where
- 38 sites in Argentina, Chile and 3 more
- Volunteers
- 1,507 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Meningococcal Meningitis
Study to Assess Immunegnicity & Safety of Pentavalent Meningococcal Vaccine (NmCV-5)
This observer-blind, randomized, active controlled trial will be conducted among 2-29 year olds in two sites (Mali and The Gambia).
- Trial name
- NCT03964012
- Testing
- NmCV-5, Menactra
- Where
- 2 sites in Mali, The Gambia
- Volunteers
- 1,800 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.
Gram-Positive Bacterial Infections, Escherichia Coli Infections
Study Evaluating Piperacillin-Tazobactam on Certain Bacteria in Hematology and Oncology Units
To determine the value of increasing use of piperacillin/tazobactam as empiric therapy and restricting extended-spectrum cephalosporins in reducing the cases of ESBL producing Escherichia coli and Klebsiella pneumoniae in…
- Conditions
- Gram-Positive Bacterial Infections, Escherichia Coli Infections, Klebsiella Infections
- Trial name
- NCT00167999
- Testing
- piperacillin-tazobactam
- Where
- South Korea
- Volunteers
- 200 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Mental Health Issue
A Clinical Trial for the Treatment of Carbapenem Resistant Gram-negative Bacterial Infection With Colistimethate Sodium for Injection
A clinical study to evaluate Colistimethate Sodium for Injection combination with Meropenem versus Coly-Mycin® M Parenteral combined with Meropenem in the treatment of Carbapenem resistant gram-negative bacteria infection.
- Trial name
- NCT06198764
- Testing
- Colistimethate sodium for injection, Meropenem for Injection, Coly Mycin M Injectable Product
- Where
- 32 sites in China
- Volunteers
- 80 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Meningococcal Meningitis
A Clinical Trial of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in 7 to 17 Year Olds
This is a randomized, blinded, 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 ratio.
- Trial name
- NCT06700148
- Testing
- MCV4, MPSV4
- Where
- 2 sites in China
- Volunteers
- 840 people, healthy volunteers welcome
- Sponsor
- CanSino Biologics Inc.
Meningitis, Meningococcal Meningitis
Antibody Persistence and Response to Re-vaccination With Either Menactra® or Menomune® 3 Years After Initial Vaccination
The purpose of this trial is to describe antibody persistence and response to re-vaccination with either Menactra® or Menomune® vaccine approximately three years following initial vaccination in adults who participated in trial…
- Conditions
- Meningitis, Meningococcal Meningitis, Meningococcal Infections
- Trial name
- NCT01239043
- Testing
- Menomune®: A, C, Y, W 135 Meningococcal Polysaccharide, Menactra®: Meningococcal (A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate
- Where
- 6 sites in United States
- Volunteers
- 139 people, healthy volunteers welcome
- Sponsor
- Sanofi
Gram-negative Bacterial Infections
Study of 2 Medicines (Aztreonam and Avibactam) Compared to Best Available Therapy for Serious Gram-negative Infections
The purpose of this study is to evaluate how Aztreonam (ATM) and Avibactam (AVI) are processed in pediatric participants. This study also aims to understand participant safety and effects in pediatric participants.
- Trial name
- NCT05639647
- Testing
- ATM-AVI, BAT
- Where
- 22 sites in United States, China and 6 more
- Volunteers
- 48 people
- Sponsor
- Pfizer
Meningitis, Meningococcal Meningitis
Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Toddlers
The purpose of the study was to evaluate the immunogenicity and safety profile of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) Conjugate vaccine when given alone compared to…
- Conditions
- Meningitis, Meningococcal Meningitis, Meningococcal Infections
- Trial name
- NCT03205358
- Testing
- Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine, Meningococcal Polysaccharide groups A, C, W-135 and Y Conjugate Vaccine
- Where
- 8 sites in Finland
- Volunteers
- 188 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Surgical Site Infection, Staphylococcus Aureus Infection
Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG®
DUOFAG® is a phage cocktail containing bacteriophages active against Staphylococcus aureus and Pseudomonas aeruginosa. It is an investigational medicinal product for the treatment of surgical site infections caused by S.
- Conditions
- Surgical Site Infection, Staphylococcus Aureus Infection, Pseudomonas Aeruginosa Infection, Bacterial Infections
- Trial name
- NCT06319235
- Testing
- IMP
- Where
- Czechia
- Volunteers
- 52 people
- Sponsor
- MB PHARMA s.r.o.
Meningitis, Meningococcal Infection
Post-licensure Safety Surveillance Study of Menactra Vaccine When Administered As a 2-dose Schedule to Children
This is a passive-surveillance study that will accrue subjects for surveillance. For each accrued subject, surveillance for outcomes will continue for six months following the first dose.
- Trial name
- NCT01689155
- Testing
- Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
- Where
- United States
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company