Clinical trials: Gram-positive Bacterial Infections
Pneumococcal Infections
Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-028)
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114 administered subcutaneously or intramuscularly in healthy Japanese infants (3 months of age).
- Trial name
- NCT03848065
- Testing
- V114, Pneumococcal 13-valent Conjugate Vaccine (PCV13), Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio (Sabin strain) Combined Vaccine (DTaP-IPV)
- Where
- 14 sites in Japan
- Volunteers
- 133 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Diphtheria, Tetanus
Study of the Booster Effect of DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ and Prevenar™ in Healthy Infants
This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722). The objectives are: To describe the antibody persistence to any antigen contained in the investigational DTaP-IPV-Hep B-PRP-T vaccine…
- Conditions
- Diphtheria, Tetanus, Whooping Cough, Hepatitis B
- Trial name
- NCT01444781
- Testing
- DTaP-IPV-Hep B-PRP~T combined vaccine + Pneumococcal polysaccharide, DTaP-Hep B-IPV // Hib Vaccine + Pneumococcal polysaccharide, DTaP-IPV-Hep B-PRP~T + Pneumococcal polysaccharide vaccine
- Where
- 2 sites in Colombia, Costa Rica
- Volunteers
- 1,106 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Tuberculosis, Pulmonary, Tuberculosis, MDR
Adjunctive Acetylsalicylic Acid and Ibuprofen for Tuberculosis
The purpose of this study is to assess the efficacy and safety of 2 repurposed drugs (acetylsalicylic acid and ibuprofen), for use as adjunct therapy added to, and compared with, the standard of care (SoC) WHO-recommended TB…
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, MDR, Tuberculosis Infection
- Trial name
- SMA-TB (NCT04575519)
- Testing
- Control group, ASA group, IBU group
- Where
- 3 sites in Georgia, South Africa
- Volunteers
- 426 people
- Sponsor
- Fundació Institut Germans Trias i Pujol
Staphylococcal Skin Infections
Safety and Efficacy of Daptomycin for the Treatment of Complicated Skin and Skin-structure Infections
This study will evaluate the safety and efficacy of daptomycin against complicated skin and skin-structure infections in adults
- Trial name
- NCT00463801
- Testing
- Daptomycin
- Where
- 2 sites in Italy
- Volunteers
- 52 people
- Sponsor
- Novartis
Staphylococcal Bacteraemia
DOTS: Dalbavancin as an Option for Treatment of Staphylococcus Aureus Bacteremia
This is a Phase 2b clinical study, multicenter, randomized, open-label, assessor-blinded, superiority study. The study will compare dalbavancin to standard of care antibiotic therapy for the completion of therapy in patients with…
- Trial name
- NCT04775953
- Testing
- Cefazolin, Dalbavancin, Daptomycin
- Where
- 24 sites in United States, Canada
- Volunteers
- 200 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Diphtheria, Tetanus
Safety of a Booster Dose of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Healthy Vietnamese Children
This study will evaluate the safety and reactogenicity of GSK Biologicals' combined reduced-antigen-content diphtheria-tetanus-acellular pertussis (dTpa) vaccine, Boostrix™ when given as a single injection to 6-10 year old…
- Conditions
- Diphtheria, Tetanus, Acellular Pertussis
- Trial name
- NCT01988857
- Testing
- Boostrix™
- Where
- Vietnam
- Volunteers
- 302 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tuberculosis, HIV Infections
Brief Rifapentine-Isoniazid Evaluation for TB Prevention (BRIEF TB)
HIV-infected people have an increased risk of developing active tuberculosis (TB). At the time the study was designed, the standard course of treatment for TB was 6 to 9 months of isoniazid (INH).This study compared the safety…
- Trial name
- NCT01404312
- Testing
- Rifapentine (RPT), Isoniazid (INH), Pyridoxine (Vitamin B6)
- Where
- 45 sites in United States, Botswana and 8 more
- Volunteers
- 3,000 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
Pneumococcal Infections
Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in PPSV23-vaccinated Healthy Adults ≥65 Years of Age (V114-007)
This study is designed to assess the safety, tolerability, and immunogenicity of V114 compared with Prevnar 13™ in healthy adults 65 years of age or older previously vaccinated with 23-valent pneumococcal polysaccharide vaccine.
- Trial name
- NCT02573181
- Testing
- V114, Prevnar 13™
- Volunteers
- 253 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Pneumococcal Infections
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Allogeneic Hematopoietic Stem Cell Transplant Recipients (V114-022/PNEU-STEM)
The purpose of this study is to 1) evaluate the safety and tolerability, and immunogenicity of blinded V114 and Prevnar 13™ within each vaccination group, and 2) evaluate the safety and tolerability, and immunogenicity of…
- Trial name
- NCT03565900
- Testing
- V114, Prevnar 13™, PNEUMOVAX™23
- Where
- 52 sites in United States, Australia and 8 more
- Volunteers
- 277 people
- Sponsor
- Merck Sharp & Dohme LLC
Clostridium Infections, Diarrhea
PAR-101/OPT-80 Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
This is a comparative study to investigate the safety and efficacy of PAR-101/OPT-80 (fidaxomicin) versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).
- Trial name
- NCT00468728
- Testing
- PAR-101/OPT-80, Vancomycin
- Where
- 116 sites in United States, Belgium and 7 more
- Volunteers
- 535 people
- Sponsor
- Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Clostridium Difficile Diarrhea
Efficacy of Metronidazole Prophylaxis Against Clostridium Difficile-Associated Diarrhea in High Risk Adult Patients
The purpose of this study is to test if metronidazole prophylaxis is effective in decreasing the incidence of hospital induced Clostridium Difficile diarrhea among patients at high risk for this infection.
- Trial name
- NCT02200328
- Testing
- Metronidazole
- Where
- United States
- Volunteers
- 76 people
- Sponsor
- Alison Schneider
Skin and Subcutaneous Tissue Bacterial Infections, Staphylococcus Aureus
Staph Household Intervention for Eradication (SHINE)
The investigators propose a pragmatic comparative effectiveness trial evaluating several decolonization strategies in patients with Staphylococcus aureus infection, their household contacts, and household environmental surfaces.
- Conditions
- Skin and Subcutaneous Tissue Bacterial Infections, Staphylococcus Aureus, MRSA - Methicillin Resistant Staphylococcus Aureus Infection
- Trial name
- SHINE (NCT02572791)
- Testing
- Chlorhexidine, Mupirocin, Household cleaning
- Where
- 2 sites in United States
- Volunteers
- 835 people
- Sponsor
- Washington University School of Medicine
Clostridium Difficile Infection, Diarrhea
TOX NEG Trial: Clostridium Difficile Diagnosis and Treatment
The purpose of this study is to determine the risks and benefits of antibiotic treatment for Clostridium difficile infection (CDI) among patients whose stool samples are nucleic acid amplification test (NAAT) positive and enzyme…
- Trial name
- NCT03388268
- Testing
- Oral Vancomycin, Toxin enzyme immunoassay, Nuceleic acid amplification test
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Washington University School of Medicine
Gram-Positive Bacterial Infections
Post Marketing Surveillance Study on Linezolid
The purpose of this study is to determine if Linezolid is safe for adult Filipino patients diagnosed with gram positive infections.
- Trial name
- A5951090 (NCT01564758)
- Testing
- Linezolid
- Volunteers
- 99 people
- Sponsor
- Pfizer
Infections, Streptococcal
Immunogenicity and Safety of Two Formulations of GSK Biologicals' Pneumococcal Vaccine (2830929A and 2830930A) When Administered in Healthy Infants
The purpose of this study is to assess the immunogenicity, reactogenicity and safety of two formulations of GSK Biologicals' pneumococcal vaccine (2830929A and 2830930A) administered as 3-dose primary vaccination during the first…
- Trial name
- NCT01616459
- Testing
- Pneumococcal conjugate vaccine GSK2830929A, Pneumococcal conjugate vaccine GSK2830930A, Synflorix™
- Where
- 42 sites in Czechia, Germany and 2 more
- Volunteers
- 953 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Cystic Fibrosis
Aztreonam Lysine for Pseudomonas Infection Eradication Study
This is an open-label, multi-center study in pediatric patients age 3 months to less than 18 years with cystic fibrosis (CF) and newly detected Pseudomonas aeruginosa (PA) pulmonary colonization/infection.
- Trial name
- ALPINE (NCT01375049)
- Testing
- Aztreonam for Inhalation Solution (AZLI)
- Where
- 58 sites in United States, Austria and 7 more
- Volunteers
- 105 people
- Sponsor
- Gilead Sciences
Varicella, Measles
Immunogenicity and Safety Study of Proquad® and Infanrix® Hexa When Administered Concomitantly (V221-035)
Primary Objective: To demonstrate that ProQuad® can be administered concomitantly with a booster dose of Infanrix® hexa to healthy children 12 to 23 months of age without impairing either the antibody response rates to measles…
- Conditions
- Varicella, Measles, Mumps, Rubella
- Trial name
- NCT00432042
- Testing
- ProQuad®, Infanrix® hexa
- Where
- 50 sites in Germany, Italy
- Volunteers
- 955 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Tuberculosis, Iron Deficiency Anemia
Universal Screening for Tuberculosis and Anemia With the CHICA System
The CHICA system is a clinical decision support system that uses adaptive turnaround documents to provide point-of-care information to clinicians.
- Trial name
- NCT01322841
- Testing
- CHICA Diagnosis Module
- Where
- United States
- Volunteers
- 2,239 people, healthy volunteers welcome
- Sponsor
- Indiana University
Leprosy
Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar
This is a cluster randomized trial on effectiveness of different modalities of Single Double Dose of Rifampicin Post-Exposure Prophylaxis (SDDR-PEP) for leprosy in the Comoros (Anjouan and Mohéli) and Madagascar.
- Trial name
- PEOPLE (NCT03662022)
- Testing
- Rifampicin
- Where
- 3 sites in Comoros, Madagascar
- Volunteers
- 144,000 people, healthy volunteers welcome
- Sponsor
- Institute of Tropical Medicine, Belgium