Clinical trials: Bacterial Infection
Gram-negative Bacterial Infections
Study of 2 Medicines (Aztreonam and Avibactam) Compared to Best Available Therapy for Serious Gram-negative Infections
The purpose of this study is to evaluate how Aztreonam (ATM) and Avibactam (AVI) are processed in pediatric participants. This study also aims to understand participant safety and effects in pediatric participants.
- Trial name
- NCT05639647
- Testing
- ATM-AVI, BAT
- Where
- 22 sites in United States, China and 6 more
- Volunteers
- 48 people
- Sponsor
- Pfizer
Gram-negative Bacterial Infection
A Study to Learn About the Study Medicine Aztreonam-Avibactam (ATM-AVI) in Infants and Newborns Admitted in Hospitals With Bacterial Infection (CHERISH)
The purpose of this study is to learn about the safety and effects of ATM-AVI for the possible treatment of infections caused by a type of bacteria called gram-negative bacteria.
- Trial name
- CHERISH (NCT06462235)
- Testing
- Part A: ATM-AVI Single Dose, Cohorts 1-4, Part B: Multiple-dose ATM-AVI, Cohorts 1-4
- Where
- 32 sites in United States, Argentina and 7 more
- Volunteers
- 48 people
- Sponsor
- Pfizer
Healthy Volunteers, Fungal Infections
A Pilot of Pediatric/Adult Study of Gene Expression Profiling and Clinical Characterization of Phototoxicity
This study will examine the phototoxicity, a reaction to light that is like exaggerated sunburn, which occurs in people who take medications such as voriconazole, a medication used to fight fungus.
- Conditions
- Healthy Volunteers, Fungal Infections, Bacterial Infections
- Trial name
- NCT00353158
- Testing
- Doxycycline, Voriconazole
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Sepsis, Neonatal Mortality
Clean Trial - Chlorination to Reduce Enteric and Antibiotic Resistant Infections in Neonates
The CLEAN (ChLorine to reduce Enteric and Antibiotic resistant infections in Neonates) cluster randomized controlled trial in western Kenya will evaluate the impact of a multi-component chlorination intervention in health care…
- Conditions
- Sepsis, Neonatal Mortality, Antibiotic Resistant Infection, Enteric Infections
- Trial name
- CLEAN (NCT06824350)
- Testing
- chlorination for water disinfection and surface disinfection, infection prevention and control messaging
- Where
- 2 sites in United States, Kenya
- Volunteers
- 45,450 people, healthy volunteers welcome
- Sponsor
- University of California, Berkeley
Severe Bacterial Infections
Identification of Clinical, Genetic and Immunological Factors Involved in the Development of Severe Bacterial Infections in Pediatrics
Severe bacterial infections (SBI) are responsible for significant morbidity and mortality in the paediatric population. There is considerable individual variability in children's susceptibility to developing SBIs.
- Trial name
- IBSoFACTo (NCT07111793)
- Testing
- Extended phenotyping, Blood sample for WES, Blood sample for PBMC freezing
- Where
- 7 sites in France
- Volunteers
- 1,401 people
- Sponsor
- Nantes University Hospital
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
Pneumonia, Bacterial, Pneumonia Childhood
Discharge Stewardship in Children's Hospitals
The goal of this interventional study is to test if a discharge stewardship bundle is effective at reducing inappropriate antibiotic prescriptions at hospital discharge for children with the three common infections…
- Conditions
- Pneumonia, Bacterial, Pneumonia Childhood, Urinary Tract Infections, Soft Tissue Infections
- Trial name
- DISCO (NCT05826873)
- Testing
- Discharge antibiotic stewardship intervention
- Where
- 5 sites in United States
- Volunteers
- 1,131 people
- Sponsor
- Children's Hospital of Philadelphia
Urinary Tract Infections
A Study in Pediatric Participants Aged ≥2 to <12 Years With a Suspected or Confirmed Bacterial Infection or Receiving Prophylaxis Antibiotics
The study will be conducted to evaluate how a single oral dose of Gepotidacin is processed in the body over time along with safety monitoring in hospitalized pediatric participants who are receiving a standard of care treatment…
- Trial name
- NCT07371429
- Testing
- Gepotidacin, SOC
- Where
- 4 sites in United States
- Volunteers
- 25 people
- Sponsor
- GlaxoSmithKline
Sepsis, Bloodstream Infection
Microbiology Operations & Time Optimization in Sepsis
The goal of this study is to simulate turn-around times of blood cultures from blood culture collection to final communication of the result.
- Conditions
- Sepsis, Bloodstream Infection, Bacterial Infections, Septic Shock
- Trial name
- MOTION-Sepsis (NCT07817043)
- Testing
- laboratory infrastructure
- Where
- Germany
- Volunteers
- 1,000 people
- Sponsor
- University Medicine Greifswald
Bacterial Vaginosis, Vaginal Microbiome
Single Arm Trial of Menstrual Cups Among Economically Vulnerable Women to Reduce Bacterial Vaginosis and STIs
HIV remains a global pandemic with 37 million infected. In western Kenya, 16% of women in the general population and 29% of the poorest women have HIV.
- Conditions
- Bacterial Vaginosis, Vaginal Microbiome, Chlamydia Trachomatis Infection, Neisseria Gonorrheae Infection
- Trial name
- POWWERHealth (NCT05666778)
- Testing
- Menstrual Cup
- Where
- 2 sites in United States, Kenya
- Volunteers
- 408 people, healthy volunteers welcome
- Sponsor
- Rush University Medical Center
Bacterial Infections
Dose-finding, Pharmacokinetics, and Safety of VABOMERE in Pediatric Subjects With Bacterial Infections
A single dose infusion of Vabomere (meropenem-vaborbactam) is being tested for dose-finding, pharmacokinetics, safety, and tolerability in pediatric subjects from birth to less than 18 years of age with serious bacterial…
- Trial name
- TANGOKIDS (NCT02687906)
- Testing
- Vabomere
- Where
- 9 sites in United States
- Volunteers
- 39 people
- Sponsor
- Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC)
Diarrhea, Gastroenteritis
Rifaximin 200 mg Plus Oral Rehydration vs Oral Rehydration Alone in Children With Acute Diarrhea
The goal of this clinical trial is to learn how rifaximin 200 mg is processed in the body (pharmacokinetics) in children 6 to 11 years old with acute diarrhea that may be caused by bacteria.
- Conditions
- Diarrhea, Gastroenteritis, Bacterial Infection, Acute Diarrhea
- Trial name
- NCT07285785
- Testing
- Rifaximin 200 mg Tablet, Oral Rehydration Therapy (ORT)
- Where
- 10 sites in United States
- Volunteers
- 54 people
- Sponsor
- Bausch Health Americas, Inc.
Cystic Fibrosis in Children, Respiratory Bacterial Infection
Viral Infections and Airway Microbiome in Young Children With Cystic Fibrosis
Cystic fibrosis (CF) is the most common hereditary life-threatening condition in Belgium. Because of a dysfunctional cystic fibrosis transmembrane conductance regulator (CFTR) channel, chloride is unable to move to the cell…
- Conditions
- Cystic Fibrosis in Children, Respiratory Bacterial Infection, Respiratory Viral Infection, Inflammation Lungs
- Trial name
- NCT06188988
- Where
- Belgium
- Volunteers
- 22 people
- Sponsor
- University Hospital, Antwerp
Bacterial Infections
Impact of Procalcitonin-guided Algorithm on Early Discontinuation of Antibiotic Therapy
In this randomized controlled open-label trial, conducted in 7 French Pediatric and Neonatal Intensive Care Units (ICUs), investigator team hypothesize that the use of a procalcitonin (PCT)-guided algorithm to discontinue…
- Trial name
- PRODISCO (NCT05350813)
- Testing
- Measurement of the PCT plasma levels, Usual practice based on guidelines
- Where
- 8 sites in France
- Volunteers
- 296 people
- Sponsor
- University Hospital, Toulouse
Pneumococcal Infections, Streptococcal Infections
A Study to Evaluate the Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine (PCV13i) in Healthy Infants Aged 2 Months (Minimum 6 Weeks)
This is a Phase 3 randomized, observation-blinded, active-controlled, parallel-group clinical trial designed to evaluate the immunogenicity, safety, and functional antibody response of the experimental vaccine versus the control…
- Conditions
- Pneumococcal Infections, Streptococcal Infections, Bacterial Infections
- Trial name
- NCT07017777
- Testing
- PCV13i, Prevnar 13
- Where
- 3 sites in Thailand
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- CanSino Biologics Inc.
Pneumococcal Infections, Streptococcal Infections
A Clinical Trial of the 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197/Tetanus Toxoid)
This clinical study will enroll 100 participants from the 2-month-old (minimum 6 weeks) group who previously participated in the Phase III clinical trial of the 13-valent pneumococcal polysaccharide conjugate vaccine (CRM197, TT…
- Conditions
- Pneumococcal Infections, Streptococcal Infections, Bacterial Infections
- Trial name
- NCT07648641
- Testing
- Previously vaccinated with PCV13 (CanSino), Previously vaccinated with PCV13 (Pfizer)
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- CanSino Biologics Inc.
Fever, Triage
Triage Performance and Physiological Predictors of Serious Illness in Febrile Children in the Pediatric Emergency Department
This multicenter prospective observational cohort study evaluates how well the initial triage category assigned by the Turkish Ministry of Health three-level color-coded triage system (Red-Yellow-Green) predicts serious clinical…
- Conditions
- Fever, Triage, Pediatric Emergency Medicine, Serious Bacterial Infection
- Trial name
- PEDTRIAGE (NCT07739004)
- Testing
- Ministry of Health three-level color-coded triage
- Where
- 10 sites in Turkey (Türkiye)
- Volunteers
- 3,000 people
- Sponsor
- TC Erciyes University
Hematologic Neoplasms, Gram-Negative Bacterial Infections
Ceftazidime-Avibactam PK/PD and Resistance in Hematology Patients
This is a prospective, single-arm, observational, exploratory clinical study to evaluate whether the standard fixed dose of ceftazidime-avibactam (CAZ-AVI) achieves sufficient drug exposure (pharmacokinetic/pharmacodynamic, or…
- Conditions
- Hematologic Neoplasms, Gram-Negative Bacterial Infections, Pseudomonas Aeruginosa Infection, Klebsiella Pneumoniae Infections
- Trial name
- CZA-TDM (NCT07703644)
- Testing
- Ceftazidime-avibactam, Therapeutic Drug Monitoring (TDM) and Microbiological Surveillance
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Sizhou Feng
Sickle Cell Disease (SCD), Invasive Bacterial Infections
Epidemiology of Invasive Bacterial Infections in Children With Sickle Cell Disease in France Between 2020 and 2025
Children with sickle cell disease are at high risk of invasive bacterial infections, which may lead to serious complications. Preventive measures, including antibiotic prophylaxis and vaccination, have changed the epidemiology of…
- Trial name
- DREPIBAC (NCT07639008)
- Where
- 31 sites in France
- Volunteers
- 350 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Cystic Fibrosis (CF), Pulmonary Exacerbation
Pharmacokinetics of Antibiotics in Patients With Cystic Fibrosis Trated With Elexacaftor/Tezacaftor/Ivacaftor (ETI)
Cystic fibrosis (CF) is associated with major pharmacokinetic and pharmacodynamic alterations affecting antibiotic exposure, including changes in absorption, distribution, metabolism, and elimination.
- Conditions
- Cystic Fibrosis (CF), Pulmonary Exacerbation, Respiratory Infection Bacterial
- Trial name
- PKCF (NCT07629986)
- Testing
- No intervention assigned
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Fondation Ildys