Clinical trials: Bacterial Infections
Inhalational Anthrax
A Field Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Inhalational Anthrax Patients
This study will evaluate safety and clinical benefit of AIGIV used for treatment of patients with inhalational anthrax. This study will be implemented only in the event of a major anthrax exposure event.
- Trial name
- NCT03569553
- Testing
- AIGIV
- Volunteers
- 100 people
- Sponsor
- Emergent BioSolutions
Tuberculosis
A Safety and Immunogenicity Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31)
The study has the following objectives: Primary objective To evaluate the safety profile of an adjuvanted TB subunit vaccine administered in different antigen/adjuvant formulations at 0 and 2 months Secondary objective To…
- Trial name
- THYB-03 (NCT01049282)
- Testing
- Antigen (Ag85B-ESAT-6), Antigen (Ag85B-ESAT-6) with adjuvant (IC31)
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Statens Serum Institut
Meningitis, Meningococcal Infection
Immunogenicity and Safety of Menactra® Vaccine in Subjects Aged 9 to 23 Months in India and in the Russian Federation
The purpose of this study is to assess the immunogenicity and safety of Menactra® vaccine given as a two-dose series in infants and toddlers.
- Trial name
- NCT01890759
- Testing
- Meningococcal Diphtheria Toxoid Vaccine
- Where
- 8 sites in India, Russia
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Staphylococcal Infection
Staphylokinase and ABO Group Phenotype: New Players in Staphylococcus Aureus Implant-associated Infections Development
The purpose of this study is to identify bacterial and/or clinical features involved in the pathogenesis of Staphylococcus aureus implant-associated infections (IAI). Materials \& methods: In total, 57 IAI S.
- Trial name
- NCT02812446
- Testing
- IAI infection, Staphylococcus aureus nasal carriage infection
- Where
- France
- Volunteers
- 88 people
- Sponsor
- Nantes University Hospital
Clostridium Difficile Infection
Fecal Microbiota Transplant
The study will provide data to show the effectiveness of Fecal Microbiota Transplant in patients with recurrent Clostridium difficile infection.
- Trial name
- NCT04090346
- Testing
- Fecal Microbiota Transplant
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Methodist Health System
Bacterial Vaginosis
Clinical Performance of a Vaginal Pessary (pHyph) in Bacterial Vaginosis
This is an open-label, single-armed, multi-center study to evaluate clinical performance, tolerability, and safety of Gedea Pessary in 24 adult women with confirmed bacterial vaginosis (BV) according to fulfillment of at least 3…
- Trial name
- NCT03762083
- Testing
- pHyph generation I
- Where
- 2 sites in Sweden
- Volunteers
- 24 people
- Sponsor
- Gedea Biotech AB
Opioid Use Disorder, HIV
Integrated Care Versus Usual Care for Opioid Use Disorder and Infectious Diseases in Veterans
Opioid use disorder (OUD) confers a higher risk of acquiring and transmitting infectious diseases, which may have long-term health consequences in Veterans.
- Conditions
- Opioid Use Disorder, HIV, Hepatitis C Virus, Gonorrhea
- Trial name
- NCT06766331
- Testing
- Integrated care
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
Diarrhea, Cholera
Randomized Controlled Trial of Killed Oral Cholera Vaccine in Kolkata
The primary purpose of this study is to estimate the efficacy of a two-dose regimen of the oral killed bivalent cholera vaccine when administered to individual residing in a cholera-endemic area in India.
- Conditions
- Diarrhea, Cholera, Vibrio Infections
- Trial name
- NCT00289224
- Testing
- bivalent killed whole cell oral cholera vaccine
- Where
- India
- Volunteers
- 69,329 people, healthy volunteers welcome
- Sponsor
- International Vaccine Institute
Tuberculosis, Children, Only
Integrating Pediatric TB Services Into Child Healthcare Services in Africa
Under-diagnosis of TB in children is a critical gap to address. The INPUT study is a multinational stepped-wedge cluster-randomized intervention study aiming to assess the effect of integrating TB services into child healthcare…
- Conditions
- Tuberculosis, Children, Only, Diagnosis, Delivery of Health Care
- Trial name
- INPUT (NCT03862261)
- Testing
- Integrated pediatric TB services
- Where
- 12 sites in Cameroon, Kenya
- Volunteers
- 1,715 people
- Sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
Tuberculosis, Pulmonary
Atorvastatin to Reduce Inflammation After Tuberculosis Treatment Completion
This is a proof-of-concept phase IIB, double-blind, randomized, placebo-controlled trial to evaluate the safety and efficacy of 40 mg atorvastatin to reduce persistent lung inflammation after successful TB treatment completion in…
- Trial name
- StatinTB (NCT04147286)
- Testing
- Atorvastatin 40mg
- Where
- South Africa
- Volunteers
- 220 people
- Sponsor
- University of Cape Town
Healthy Volunteers (Meningococcal Infection)
Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the Russian Federation and Mexico
Primary Objective: 1. To describe the vaccine seroprotection (antibody titer greater than or equal to [>=] 1:8) to the antigens (meningococcal serogroups A, C, Y, and W) present in MenACYW Conjugate vaccine or Menveo® measured by…
- Trial name
- MET33 (NCT03630705)
- Testing
- Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine, Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine, Measles, Mumps, and Rubella Virus Vaccine Live
- Where
- 11 sites in Mexico, Russia
- Volunteers
- 525 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Multidrug-resistant Tuberculosis
Pharmacometric Optimization of Second Line Drugs for MDR Tuberculosis Treatment
Multidrug-resistant (MDR) tuberculosis (TB), defined as simultaneous resistance to isoniazid and rifampin, has been declared a global emergency.
- Trial name
- PODrtb (NCT02727582)
- Where
- 2 sites in South Africa
- Volunteers
- 142 people
- Sponsor
- University of Cape Town
Clostridium Difficile Infections
Virus as Treatment of C. Difficile Infection (VISION)
Fecal Virome Transplantation (FVT) has in small studies shown benefit in the treatment of recurrent C. difficile infection. In the VISION study we will treat patients with recurrent C.
- Trial name
- VISION (NCT06398379)
- Testing
- Fecal Virome Transplantation, Fecal microbiota Transplantation
- Where
- Denmark
- Volunteers
- 40 people
- Sponsor
- Copenhagen University Hospital, Hvidovre
Cholera, Vibrio Cholerae Infection
Effect of Extended Dose Intervals on the Immune Response to Oral Cholera Vaccine
Cholera is a life-threatening disease if prompt actions are not taken. The most recent estimates of the global burden of cholera estimate that there are more than 1.3 billion people at risk.
- Trial name
- NCT03373669
- Testing
- Oral Cholera Vaccine, Adjusted Dose Oral Cholera Vaccine
- Where
- Zambia
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Tuberculosis, Pulmonary
Co-Infection of NTM in Patients With Smear Positive Pulmonary TB
The aim of this study is to elucidate the prevalence of nontuberculous mycobacterial (NTM) co-infection in patients with smear positive pulmonary TB.
- Trial name
- NCT00567151
- Where
- South Korea
- Volunteers
- 200 people
- Sponsor
- Seoul National University Hospital
Shigellosis
Safety Study of Inactivated Shigella Whole Cell Vaccine in Adults
This is a research study about an experimental (investigational) oral inactivated whole cell Shigella flexneri 2a killed vaccine (Sf2aWC).
- Trial name
- NCT01509846
- Testing
- Vaccine: 2.6±0.8 x 10^8 vp/mL, 1 dose, Vaccine: 2.6±0.8 x 10^9 vp/mL, 3 doses, Vaccine: 2.6±0.8 x 10^10 vp/mL, 3 doses
- Where
- 2 sites in United States
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- PATH
Mycobacterium Infections, Tuberculosis, Multidrug-Resistant
Training Protocol on the Natural History of Tuberculosis
Background: Tuberculosis (TB) is an infectious disease that affects numerous people worldwide. Researchers are interested in actively recruiting individuals with TB for research and treatment studies.
- Conditions
- Mycobacterium Infections, Tuberculosis, Multidrug-Resistant, Latent Tuberculosis, Tuberculosis
- Trial name
- NCT01212003
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Clostridioides Difficile Infection
Study of Clostridioides Difficile in Infants
Clostridioides difficile infection (CDI) poses an increasing threat to infant and young child health, with detection rates rising annually.
- Trial name
- NCT06788769
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Westlake University
Pneumonia, Bacterial, Ventilator Associated Pneumonia
MASTERMIND-Pneumonia Study (Also Known as Pneumonia Direct Pilot)
The MASTERMIND-Pneumonia Study (also known as Pneumonia Direct Pilot Study) is designed to assess whether combining molecular diagnostics for bacteria and AMR markers with host-response profiling improves agreement and predictive…
- Trial name
- PDP (NCT06181669)
- Testing
- Pathogen and Host Directed testing
- Where
- 4 sites in United States
- Volunteers
- 173 people
- Sponsor
- Duke University
Isolated Mediastinal Lymphadenopathy, Sarcoidosis
A Clinical tRial of Endobronchial Ultrasound for the Diagnosis of MEDiastinal lymphadenopathY (REMEDY)
Enlarged glands in the chest (mediastinal lymphadenopathy) is a common problem and may have a variety of different causes. In the past an operation (mediastinoscopy) was required to diagnose the glands.
- Conditions
- Isolated Mediastinal Lymphadenopathy, Sarcoidosis, Tuberculosis, Lung Cancer
- Trial name
- REMEDY (NCT00932854)
- Testing
- EBUS
- Where
- United Kingdom
- Volunteers
- 75 people
- Sponsor
- University College London Hospitals