Clinical trials: Gram-positive Bacterial Infections
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
Infections, Streptococcal
Immunization of Children Previously Primed With GSK Pneumococcal Vaccine GSK1024850A and of Unprimed Children in Mali
The purpose of this trial is to assess the safety, reactogenicity and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A when administered either as a booster dose or as a two dose catch-up vaccination…
- Trial name
- NCT00985465
- Testing
- Pneumococcal vaccine GSK1024850A
- Where
- Mali
- Volunteers
- 218 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Late Effects of Surgery, Staphylococcus Aureus
Pharmacokinetics of Daptomycin During Cardiopulmonary Bypass Surgery
This investigation is a prospective, open-label pharmacokinetic study of daptomycin prophylaxis in patients undergoing coronary artery bypass graft surgery without valvular replacement.
- Conditions
- Late Effects of Surgery, Staphylococcus Aureus, Surgical Site Infection
- Trial name
- NCT00701636
- Testing
- daptomycin
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Staphylococcal Infections
Preventing Staphylococcal (Staph) Infection
The purpose of this study is to determine if mupirocin 2% in polyethylene glycol (PEG) ointment [Treatment Arm] is effective in preventing moderate to severe re-infection with Staphylococcus aureus compared with treatment with…
- Trial name
- NCT00108160
- Testing
- Mupirocin Ointment [Treatment]
- Where
- United States
- Volunteers
- 146 people
- Sponsor
- US Department of Veterans Affairs
MDR-TB
The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB
Tuberculosis (TB) is a common, infectious, bacterial disease that is spread when an infected person transmits their saliva through the air by coughing or sneezing.
- Trial name
- STREAM (NCT02409290)
- Testing
- Regimen A locally-used WHO-approved MDR-TB regimen (2011 guideline), Moxifloxacin, Clofazimine
- Where
- 13 sites in Ethiopia, Georgia and 5 more
- Volunteers
- 588 people
- Sponsor
- IUATLD, Inc
Tetanus, Poliomyelitis
Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 3, 5 and 11 Months of Age.
This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine given as a three-dose vaccination course at 3, 5 and 11 months of age.
- Conditions
- Tetanus, Poliomyelitis, Neisseria Meningitidis, Haemophilus Influenzae Type b
- Trial name
- NCT00871741
- Testing
- GSK2202083A vaccine, Infanrix hexa, Menjugate
- Where
- 8 sites in Slovakia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Mycobacterium Infections, Nontuberculous
Liposomal Amikacin for Inhalation (LAI) for Nontuberculous Mycobacteria
The purpose of this study is to evaluate the efficacy, safety and tolerability of 84 days of daily dosing of 590 mg of LAI versus placebo in patients with treatment refractory NTM lung disease.
- Trial name
- NCT01315236
- Testing
- Liposomal amikacin for inhalation (LAI)
- Where
- 19 sites in United States, Canada
- Volunteers
- 90 people
- Sponsor
- Insmed Incorporated
Pertussis, Tetanus
A Trial to Evaluate the Safety and Immunogenicity of ADACEL® Vaccine in Persons 65 Years of Age and Older
It is well recognized that older adults can contract pertussis, suffer its complications, and unwittingly transmit it to close contacts, which may well include infants too young to have received their primary series of DTaP…
- Conditions
- Pertussis, Tetanus, Diphtheria
- Trial name
- NCT00457249
- Testing
- ADACEL®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed, DECAVAC®: Tetanus and Diphtheria Toxoids Adsorbed
- Where
- 19 sites in United States
- Volunteers
- 1,564 people, healthy volunteers welcome
- Sponsor
- Sanofi
Tuberculosis
Safety and Immunogenicity Study of BCG, H4:IC31, and H56:IC31 Revaccination in Healthy Adolescents
The aims of the phase 1b trial described here are to facilitate identification of assays and immune responses that could then be evaluated as correlates of risk and correlates of protection in efficacy studies and ultimately to…
- Trial name
- NCT02378207
- Testing
- H4:IC31, H56:IC31, BCG
- Where
- South Africa
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Aeras
Diphtheria, Tetanus
Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.
To demonstrate that DTaP-IPV-HB-PRP~T combined vaccine does not induce a higher incidence rate of high fever than Tritanrix-HepB/Hib™ and Oral Polio Vaccine (OPV) after any of the three vaccinations at 2, 4, and 6 months of age…
- Conditions
- Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b
- Trial name
- NCT00313911
- Testing
- DTaP-IPV-HB-PRP~T, Tritanrix-HepB/Hib
- Where
- 2 sites in Mexico, Peru
- Volunteers
- 2,133 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
Bacterial Infections, Virus Diseases
A Study of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-006)
This study will determine whether three manufacturing lots of V419 (PR5I) induce similar immune responses to all of the antigens contained in V419 when given concomitantly with Prevnar13™ and RotaTeq™.
- Trial name
- NCT01340937
- Testing
- V419, PENTACEL™, Prevnar 13™
- Volunteers
- 2,808 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Pneumonia, Bacterial, Pneumococcal Infections
A Phase 2 Study to Evaluate the Safety, Tolerability, and Immune Response of AFX3772 Vaccine in Healthy Infants
This is a Phase 2 clinical study evaluating AFX3772 in healthy infants for the prevention of pneumococcal disease. The purpose of this study is to determine the safety, tolerability, and immunogenicity of three different…
- Conditions
- Pneumonia, Bacterial, Pneumococcal Infections, Pneumonia, Pneumococcal
- Trial name
- NCT05412030
- Testing
- AFX3772, Prevnar 13, Prevnar 20
- Where
- 52 sites in United States, Puerto Rico
- Volunteers
- 388 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Innate Inflammatory Response, Vaccination
PFAS Exposure and Immune Response to Vaccination in Adults
This clinical trial aims to investigate how exposure to Perfluorononanoic acid (PFNA), a type of per- and polyfluoroalkyl substance (PFAS), affects the immune response to the standard tetanus and diphtheria (Td) vaccine.
- Conditions
- Innate Inflammatory Response, Vaccination, Diphtheria, Tetanus
- Trial name
- NCT06588530
- Testing
- TENIVAC
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Rutgers, The State University of New Jersey
Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant
Trial to Evaluate the Efficacy, Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients
To evaluate the efficacy, safety and tolerability at 8 weeks (2-months), 52 weeks (12-months), and 104 Weeks (24-months) post the start of the following treatment regimens in participants with: Drug Sensitive TB (DS-TB) patients…
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Tuberculosis, MDR, Tuberculosis
- Trial name
- NCT03338621
- Testing
- Pretomanid, Bedaquiline, Moxifloxacin
- Where
- 26 sites in Brazil, Georgia and 6 more
- Volunteers
- 455 people
- Sponsor
- Global Alliance for TB Drug Development
HIV-1 Infection, Tuberculosis
PK Study of Rifampicin Interactions With DMPA and Efavirenz in TB
This study was done to evaluate the effect of HIV and TB treatment on a commonly used birth control method. It enrolled women who were infected with HIV and TB and were taking efavirenz (EFV; Sustiva®; an anti-HIV medication)…
- Trial name
- PRIDE-HT (NCT02412436)
- Testing
- Depot medroxyprogesterone acetate
- Where
- 5 sites in Botswana, Kenya and 2 more
- Volunteers
- 62 people
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Pneumococcal Disease
Safety Surveillance of Pneumococcal 13-valent Conjugate Vaccine Among Filipinos
Prevenar 13 is safe for administration to Filipinos.
- Trial name
- NCT01396434
- Testing
- Prevenar 13
- Where
- 119 sites in Philippines
- Volunteers
- 3,006 people, healthy volunteers welcome
- Sponsor
- Pfizer
Pulmonary Tuberculosis
Using Biomarkers to Predict TB Treatment Duration
Background: Tuberculosis (TB) is a bacterial lung infection. Typical treatment using anti-TB drugs lasts about 6 months. Some people with less severe TB might not need to take the drugs that long.
- Trial name
- NCT02821832
- Testing
- Saliva collection, Urine collection, Sputum collection
- Where
- South Africa
- Volunteers
- 946 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections, Tuberculosis
Characteristics and Prevalence of Tuberculosis and HIV in Masiphumelele Township, Cape Town, South Africa
The purpose of this study is to determine the number of people infected with tuberculosis (TB) in the Masiphumelele Township of Cape Town, South Africa, a community with high rates of TB and HIV.
- Trial name
- NCT00346476
- Where
- 2 sites in South Africa
- Volunteers
- 1,250 people, healthy volunteers welcome
- Sponsor
- CIPRA SA
Staphylococcus Aureus Infection
A Study to Evaluate the Safety and Immunogenicity of V710 in Adults With Kidney Disease on Hemodialysis (V710-005)(COMPLETED)
This is a study to evaluate the safety and immunogenicity of V710 with and without Merck Aluminum Adjuvant (MAA) in adult participants with end-stage kidney disease who are on hemodialysis.
- Trial name
- NCT00572910
- Volunteers
- 206 people
- Sponsor
- Merck Sharp & Dohme LLC