Clinical trials: Gram-positive Bacterial Infections
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)
Multi-drug Resistant Tuberculosis, Extensively Drug-Resistant Tuberculosis
Economic Evaluation of New MDR TB Regimens
The current treatment regimen for MDR-TB has poor outcomes and costs of treating MDR-TB are greater than treating drug susceptible TB, both in terms of health service and patient-incurred costs.
- Conditions
- Multi-drug Resistant Tuberculosis, Extensively Drug-Resistant Tuberculosis, Pulmonary Tuberculoses
- Trial name
- PRACTECAL-EE (NCT04207112)
- Testing
- Bedaquiline, Pretomanid, Moxifloxacin
- Where
- 7 sites in Belarus, South Africa and 1 more
- Volunteers
- 73 people
- Sponsor
- Medecins Sans Frontieres, Netherlands
Pneumococcal Infection
A Clinical Study of Novel Pneumococcal Vaccine V118C in Children (V118C-002)
Researchers are looking for new vaccines to prevent pneumococcal disease, which is any infection in the lungs or other parts of the body that is caused by a type of bacteria called Streptococcus pneumoniae.
- Trial name
- NCT07300267
- Testing
- V118C (Stage 1), V118C (Stage 2), PCV20 (Stage 1)
- Where
- 15 sites in United States
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Pneumococcal Infections
Study Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine
This study will assess the Immunogenicity and safety of 13-valent Pneumococcal Conjugate Vaccine compared with 23-valent Pneumococcal Polysaccharide Vaccine. All participants should be naïve of Pneumococcal vaccine.
- Trial name
- NCT02079207
- Testing
- NBP606, Prodiax-23
- Volunteers
- 767 people, healthy volunteers welcome
- Sponsor
- SK Chemicals Co., Ltd.
Leprosy
Phase 1b/2a Trial to Evaluate LEP-F1 + GLA-SE in Healthy Adults and Leprosy Patients
This is a phase 1b/2a, double-blind, randomized, placebo-controlled clinical trial to evaluate the safety, tolerability, and immunogenicity of the LEP-F1 + GLA-SE investigational vaccine compared to placebo.
- Trial name
- NCT03947437
- Testing
- LEP-F1 + GLA-SE
- Where
- Brazil
- Volunteers
- 142 people, healthy volunteers welcome
- Sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
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
Lung Diseases, Tuberculosis
Behavioral Interventions for Control of TB
To compare alternative methods to ensure completion of treatment and preventive therapy for tuberculosis (TB) in inner cities, and to identify the most cost-effective methods to accomplish that.
- Trial name
- NCT00005739
- Testing
- Community-based directly observed therapy (DOT), Clinic directly observed therapy (DOT)
- Where
- United States
- Volunteers
- 145 people
- Sponsor
- Columbia University
Anthrax
Evaluation of Clinical Benefit and Safety Following CYFENDUS Administration for Post-Exposure Prophylaxis of Anthrax Disease.
The goal of this observational study is to evaluate the safety and clinical benefit of two doses of CYFENDUS vaccine when used with the concurrent recommended antibacterial regimen for post-exposure prophylaxis to prevent…
- Trial name
- NCT07268612
- Testing
- CYFENDUS
- Volunteers
- 250 people
- Sponsor
- Emergent BioSolutions
Staphylococcus Aureus
Vancomycin vs. Vancomycin Plus Gentamycin in Treatment of MRSA Infection
The purpose of this study is to compare the outcome of treatment for bacteremic MRSA infection with vancomycin alone, vancomycin plus gentamicin, vancomycin plus rifampin, and vancomycin plus gentamicin and rifampin.
- Trial name
- NCT00304811
- Testing
- Vancomycin, Vancomycin plus Gentamicin, Vancomycin plus Rifampin
- Where
- 2 sites in United States
- Volunteers
- 160 people
- Sponsor
- Michael E. DeBakey VA Medical Center
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
Diphtheria, Acellular Pertussis
Comparison of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP and IPV Separately Administered Vaccines in Terms of Immune Response and Safety
The aims of this study are to compare the immunogenicity and safety of the GSK Biologicals' combined DTaP-IPV vaccine with separate administration of DTaP and IPV vaccines, when administered as a fifth dose of acellular pertussis…
- Conditions
- Diphtheria, Acellular Pertussis, Tetanus
- Trial name
- NCT00263692
- Testing
- Prophylaxis: Diphtheria, tetanus, pertussis, poliovirus type 1, type 2 and type 3
- Where
- 15 sites in United States
- Volunteers
- 401 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tuberculosis
Salivary Therapeutic Drug Monitoring of Anti-Tuberculosis Drugs
In tuberculosis patients, salivary concentrations will be compared to plasma/serum concentrations of several anti-tuberculosis drugs.
- Trial name
- NCT03080012
- Testing
- Saliva sampling, Plasma/serum sampling
- Where
- Netherlands
- Volunteers
- 24 people
- Sponsor
- University Medical Center Groningen
Tuberculosis Infection
Tuberculosis In Children Visiting Friends and Relatives
In countries with a low incidence of Tuberculosis (TB), the incidence remains higher among the immigrant population than among the autochthonous population beyond the first years after arrival in the host country.
- Trial name
- NCT04236765
- Testing
- TB infection-screening benefiting group
- Where
- Spain
- Volunteers
- 492 people, healthy volunteers welcome
- Sponsor
- Hospital Mutua de Terrassa
Tuberculosis, Pulmonary
Pharmacokinetics of Ethionamide and Ethionamide Sulfoxide in Patients Established on Treatment for Tuberculosis.
To determine the pharmacokinetics of ethionamide (Eto) and ethionamide-sulfoxide (Eto-SO) in participants with tuberculosis (TB) when Eto is dosed under programmatic conditions.
- Trial name
- NCT05258877
- Testing
- Plasma samples
- Where
- South Africa
- Volunteers
- 30 people
- Sponsor
- BioVersys AG
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
Tuberculosis
Electronic Pillbox-enabled SAT Versus DOT for TB Medication Adherence and Treatment Outcomes
To address the multifaceted challenges associated with tuberculosis (TB) in-person directly observed therapy (DOT), the World Health Organization recently recommended countries maximize the use of digital adherence technologies.
- Trial name
- SELFTB (NCT04216420)
- Testing
- MERM-observed self-administered therapy
- Where
- Ethiopia
- Volunteers
- 114 people
- Sponsor
- Addis Ababa University
Whipple Disease
Detection and Characteristic of Whipple Diseases in the Great Britany
Whipple's disease is a chronic systemic infection caused by ubiquitous bacterium Tropheryma wipplei on a genetic predisposition which should be considered in patients with recurrent episodes of seronegative arthritis, erosive or…
- Trial name
- WHO (NCT03350685)
- Where
- 8 sites in France
- Volunteers
- 267 people
- Sponsor
- University Hospital, Brest
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