Clinical trials: Bacterial Disease
Skin and Subcutaneous Tissue Bacterial Infections, Gram-Positive Bacterial Infections
TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection
The purpose of this study is to evaluate safety, tolerability, pharmacokinetic characteristics and efficacy of TNP-2092 in adults with ABSSSI suspected or confirmed to be caused by gram-positive pathogens.
- Trial name
- P2_ABSSSI (NCT03964493)
- Testing
- TNP-2092, Vancomycin
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- TenNor Therapeutics Limited
Clostridium Difficile Infection
Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile - Associated Diarrhea
This clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).
- Trial name
- NCT01987895
- Testing
- Cadazolid, Vancomycin
- Volunteers
- 632 people
- Sponsor
- Actelion
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
Infections, Streptococcal
Immunization of Children Between 8 Weeks and 2 Years of Age With GSK Pneumococcal Vaccine GSK1024850A
The aim of the study is to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A.
- Trial name
- NCT01175083
- Testing
- GSK1024850A (Synflorix), Tritanrix-HepB/Hib, Polio Sabin
- Where
- Burkina Faso
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tetanus, Poliomyelitis
Immunogenicity and Safety Study of GSK Biologicals' Infanrix-IPV+Hib™ Vaccine
The purpose of the study is to evaluate the immunogenicity and reactogenicity of Infanrix-IPV/Hib™ vaccine when administered to healthy Chinese infants at 2, 3 and 4 or 3, 4 and 5 months of age.
- Conditions
- Tetanus, Poliomyelitis, Acellular Pertussis, Diphtheria
- Trial name
- NCT01086423
- Testing
- Infanrix-IPV/Hib™, Infanrix Hib™, Poliorix™
- Where
- 2 sites in China
- Volunteers
- 985 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Meningococcal
Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants
The purpose of this study is to evaluate the safety and immunogenicity of Bexsero (meningococcal group B vaccine-rMenB+OMV NZ) in North American infants 6 weeks through 12 weeks of age, when administered concomitantly with…
- Trial name
- NCT03621670
- Testing
- Bexsero (GSK Biologicals' Meningococcal group-B vaccine/ rMenB+OMV NZ), Prevnar13, Pediarix
- Where
- 57 sites in United States, Puerto Rico
- Volunteers
- 1,196 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Cystic Fibrosis
Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of QBW251 in Healthy Subjects and Cystic Fibrosis Patients
This study is designed to assess the safety, tolerability, pharmacokinetics and preliminary pharmacodynamics (proof of concept) of QBW251 in healthy subjects and cystic fibrosis patients following single and multiple doses.
- Trial name
- NCT02190604
- Testing
- QBW251
- Where
- 23 sites in United States, Belgium and 5 more
- Volunteers
- 153 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Haemophilus Influenzae Type b, Neisseria Meningitidis
3 Formulations of Hib-MenCY-TT Vaccine & 1 Formulation of Hib-MenC-TT Vaccine Compared to Licensed Meningococcal Serogroup C Conjugate Vaccine, Each Administered at 2,3,4 Mths of Age
This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine and 1 formulation of Hib-MenC-TT vaccine compared to a control group receiving licensed meningococcal serogroup C conjugate vaccine…
- Trial name
- NCT00129116
- Testing
- Hib-MenCY-TT vaccine, Hib-MenC-TT vaccine, Menjugate ®
- Where
- 26 sites in Belgium, Germany
- Volunteers
- 388 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Fungal Infection, Acute Myelogenous Leukemia
Oral Posaconazole in High Risk Patients With Gastrointestinal Dysfunction (Study P05115)
The purpose of this study is: to explore the potential for different dosing strategies of posaconazole oral suspension (POS) to increase plasma levels and to profile the pharmacokinetics of these dosing strategies in patients…
- Conditions
- Fungal Infection, Acute Myelogenous Leukemia, Neutropenia
- Trial name
- NCT00686543
- Testing
- Posaconazole
- Volunteers
- 75 people
- Sponsor
- Merck Sharp & Dohme LLC
Otomycosis
SVT-15652 Otic Solution for the Treatment of Otomycosis.
Multicenter, randomized, 2-arm parallel-group, double blind, placebo-controlled study in patients suffering from Otomycosis. This study will compare the efficacy and safety of SVT-15652 otic solution to that of Placebo, when…
- Trial name
- NCT03686397
- Testing
- SVT-15652
- Where
- Spain
- Volunteers
- 194 people
- Sponsor
- Salvat
Pneumococcal Infections
A Study of Pneumococcal Conjugate Vaccine (V114) Compared to a Marketed Vaccine (V114-003)
This study will evaluate whether the aluminum-adjuvanted or the non-adjuvanted formulation of the candidate pneumococcal vaccine (V114) is non-inferior to Prevnar 13® based on immune responses to the 13 serotypes in common…
- Trial name
- NCT01215188
- Testing
- V114 Aluminum-adjuvanted, V114 Non-adjuvanted, Prevnar 13®
- Volunteers
- 1,152 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Diphtheria, Tetanus
Regulatory Post-Marketing Surveillance Study for TETRAXIM™
The purpose of this study is to assess the safety of TETRAXIM™ administered in routine clinical practice according to Korea Food and Drug Administration Notification No.
- Conditions
- Diphtheria, Tetanus, Pertussis, Poliomyelitis
- Trial name
- NCT01437423
- Testing
- TETRAXIM™: Combined adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated polio
- Where
- South Korea
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Meningitis, Meningococcal Meningitis
Study of a Quadrivalent Meningococcal Conjugate Vaccine in Subjects Aged 56 and Older
Primary objectives: To describe the antibody responses to meningococcal serogroups A, C, Y, and W 135, measured by serum bactericidal assay using human complement (hSBA) and baby rabbit complement (rSBA), induced by a single dose…
- Conditions
- Meningitis, Meningococcal Meningitis, Meningococcal Infections, Invasive Meningococcal Disease
- Trial name
- NCT01732627
- Testing
- Meningococcal Polysaccharide (A, C, Y, and W 135) Tetanus Protein Conjugate Vaccine, Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W 135 Combined
- Where
- 12 sites in United States
- Volunteers
- 301 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Infections, Streptococcal
Long-term Follow-up Study of Children Previously Primed With GSK Pneumococcal Vaccine (GSK1024850A) and of Unprimed Children
The objective of this study is to evaluate the immune memory through the administration of an additional dose of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A, the antibody persistence and long-term effect on…
- Trial name
- NCT00950833
- Testing
- Pneumococcal vaccine GSK1024850A
- Where
- 10 sites in Czechia
- Volunteers
- 466 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Wound Infection, Abscess
Oritavancin Versus IV Vancomycin for the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infection
The purpose of this Phase 3 trial is to evaluate the efficacy, safety, and tolerability of oritavancin in ABSSSIs, including those caused by MRSA and to evaluate the potential economic benefit of oritavancin administered as a…
- Conditions
- Wound Infection, Abscess, Systemic Inflammation, Cellulitis
- Trial name
- SOLO II (NCT01252732)
- Testing
- Single-Dose IV Oritavancin Diphosphate, IV Vancomycin
- Where
- United States
- Volunteers
- 1,019 people
- Sponsor
- Melinta Therapeutics, Inc.
Mycobacterium Avium Complex, Non-tuberculous Mycobacterium Pulmonary Disease
Safety, Tolerability, Pharmacokinetics and Efficacy of SPR720 for the Treatment of Patients With Mycobacterium Avium Complex (MAC) Pulmonary Disease
To evaluate the pharmacokinetics (PK) of SPR719, the active moiety, generated from the orally (po) administered SPR720 prodrug in a patient population with nontuberculous mycobacteria pulmonary disease (NTM-PD)
- Trial name
- NCT04553406
- Testing
- SPR720, Open-label Standard of Care
- Where
- 9 sites in United States
- Volunteers
- 2 people
- Sponsor
- Spero Therapeutics
Abscess, Wound Infection
Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections
The primary object is to compare the early clinical efficacy (after 48-72 hours of therapy) of dalbavancin to the comparator regimen (vancomycin with the option to switch to oral linezolid) for the treatment of patients with a…
- Conditions
- Abscess, Wound Infection, Surgical Site Infection, Cellulitis
- Trial name
- NCT01431339
- Testing
- IV Dalbavancin, Vancomycin/Linezolid
- Where
- 137 sites in United States, Bulgaria and 12 more
- Volunteers
- 739 people
- Sponsor
- Durata Therapeutics Inc., an affiliate of Allergan plc
Diphtheria, Tetanus
Study of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™
Objectives: To present the rates of adverse reactions after a dose of DAPTACEL® vaccine administered to children 4 to 6 years of age who have previously received four doses of PENTACEL™ vaccine.
- Conditions
- Diphtheria, Tetanus, Pertussis, Polio
- Trial name
- NCT00802867
- Testing
- Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®)
- Where
- 19 sites in United States
- Volunteers
- 989 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Fungal Infection
A Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients (MK-5592-105)
This single site study will examine plasma and alveolar compartment (AC) levels of posaconazole in cystic fibrosis (CF) and non-cystic fibrosis (non-CF) lung transplant recipients receiving routine post-operative anti-fungal…
- Trial name
- PAPAL (NCT01667107)
- Testing
- Posaconazole, Calogen®
- Volunteers
- 26 people
- Sponsor
- Merck Sharp & Dohme LLC
Bloodstream Infections (BSI) Due to CRE, Hospital-Acquired Bacterial Pneumonia (HABP) Due to CRE
A Study of Plazomicin Compared With Colistin in Patients With Infection Due to Carbapenem-Resistant Enterobacteriaceae (CRE)
This was a Phase 3 study containing a randomized open-label superiority cohort (Cohort 1) comparing the efficacy and safety of plazomicin with colistin when combined with a second antibiotic (either meropenem or tigecycline) in…
- Conditions
- Bloodstream Infections (BSI) Due to CRE, Hospital-Acquired Bacterial Pneumonia (HABP) Due to CRE, Ventilator-Associated Bacterial Pneumonia (VABP) Due to CRE, Complicated Urinary Tract Infection (cUTI) Due to CRE
- Trial name
- CARE (NCT01970371)
- Testing
- plazomicin, colistin, meropenem
- Volunteers
- 69 people
- Sponsor
- Achaogen, Inc.
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