Clinical trials: Bacterial Infections
Bacterial Infections
TDM-optimized Teicoplanin Dosing Versus Standard of Care
Value of TDM for teicoplanin is not well defined. In this single-center low-interventional randomized trial the investigators aim to investigate the superiority of teicoplanin TDM-optimized using Model-Informed-Precision-Dosing…
- Trial name
- PLATO-3 (NCT05914467)
- Testing
- Teicoplanin
- Where
- Netherlands
- Volunteers
- 54 people
- Sponsor
- Radboud University Medical Center
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
Infection, Bacterial
Plasma Concentrations of Amoxicillin Administered in High-doses During the First Week of Treatment (MAX-AMOX)
Amoxicillin is the most prescribed antibiotic in France. High dose intravenous amoxicillin, (dosage greater than or equal to 150 mg / kg / day or 12 g per day for patients over 80 kg) is used in the treatment, in particular, of…
- Trial name
- MAX-AMOX (NCT04070469)
- Testing
- Amoxicillin
- Where
- France
- Volunteers
- 142 people
- Sponsor
- University Hospital, Clermont-Ferrand
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
UTI, Bacterial Colonization
Risk Factors and Clinical Implications of Double-J Ureteral Stent Bacterial Colonization: A Prospective Cohort Study
To identify the risk factors associated with bacterial colonization of Double-J ureteral stents and to evaluate its clinical implications, including bacteriuria, UTI, antimicrobial resistance, and stent-related symptoms.
- Trial name
- NCT07740811
- Testing
- Urine and stent cultures
- Where
- Egypt
- Volunteers
- 400 people
- Sponsor
- Al-Azhar University
Bacterial Infection
Optimization of Beta-lactam Dosing in Critically Ill Patients With Cystatin C (OPTIMIZE-GNI)
This is a Phase 4, interventional, multi-center pharmacokinetics (PK) study in up to 200 adult patients who are residing in an ICU.
- Trial name
- NCT06709521
- Testing
- Iohexol
- Where
- 10 sites in United States
- Volunteers
- 161 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Pneumonia - Bacterial, Pseudomonas Aeruginosa Infection
MP101 in Adults With Acute Pseudomonas Aeruginosa Pneumonia
The purpose of this study is to evaluate the safety and tolerability of a single intravenous dose of MP101 administered in addition to standard antibiotic therapy in adult patients with acute Pseudomonas aeruginosa pneumonia.
- Trial name
- MP101-1001 (NCT07492771)
- Testing
- MP101, Antibiotics
- Where
- South Korea
- Volunteers
- 18 people
- Sponsor
- MicrobiotiX Co., Ltd
Bacterial Infections, Bacterial Infections and Mycoses
Large Algorithm Setting and Validation Study
In this pilot study, prospectively acquired clinician-collected and participant-collected vaginal swab specimens will be obtained from up to 1000 individuals with signs and symptoms of vaginitis to develop and validate a…
- Conditions
- Bacterial Infections, Bacterial Infections and Mycoses, Infections, Vaginitis
- Trial name
- LAVA (NCT07607470)
- Testing
- Nanopath Vaginitis Assay, BD Max™ Vaginal Panel, Cepheid Xpert® Xpress MVP
- Where
- 2 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Nanopath, Inc
Bacterial Disease Carrier, Cystic Fibrosis
A Phase 1b/2 Trial of the Safety and Microbiological Activity of Bacteriophage Therapy in Cystic Fibrosis Subjects Colonized With Pseudomonas Aeruginosa
This is a phase 1b/2 study of a single dose of intravenous (IV) bacteriophage in males and non-pregnant females, at least 18 years old, diagnosed with Cystic Fibrosis (CF).
- Trial name
- NCT05453578
- Testing
- WRAIR-PAM-CF1
- Where
- 19 sites in United States
- Volunteers
- 73 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Bronchiectasis Adult, Bronchiectasis With Pseudomonas Aeruginosa Colonization
First in Human Trial of CTX-187 in Healthy Volunteers and Chronically Infected Patients
The primary objective of this trial is to assess the safety and tolerability of single and multiple ascending intravenously (IV) infused doses of CTX-187 when administered to healthy adult male and female participants and…
- Conditions
- Bronchiectasis Adult, Bronchiectasis With Pseudomonas Aeruginosa Colonization, Bacterial Infections
- Trial name
- NCT07708116
- Testing
- CTX-187
- Where
- Netherlands
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Centauri Therapeutics Limited
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
Severe Pneumonia Caused by Multidrug-resistant Gram-negative Bacterial Infection
A Study on Integrated Chinese and Western Medicine for Severe Pneumonia Caused by Multidrug-Resistant Gram-Negative Bacterial Infections
This study aims to evaluate the clinical efficacy of a traditional Chinese medicine formula granule (Feireqing Granules) in the treatment of severe pneumonia caused by multidrug-resistant Gram-negative bacterial infections…
- Trial name
- NCT07206745
- Testing
- Fei Re Qing Granules
- Where
- China
- Volunteers
- 152 people
- Sponsor
- Henan University of Traditional Chinese Medicine
Lyme Disease
A Study to Evaluate Safety and Efficacy of TP-05 in Healthy Participants With Tick Exposure
This study is designed to evaluate the safety, tolerability, and pharmacokinetics of TP05 administered orally to healthy adult participants.
- Trial name
- NCT07562087
- Testing
- TP-05 (lotilaner) Low Dose, TP-05 (lotilaner) High Dose
- Where
- 19 sites in United States
- Volunteers
- 722 people, healthy volunteers welcome
- Sponsor
- Tarsus Pharmaceuticals, Inc.
Decompensated Cirrhosis, Bacterial Infections
Trial Comparing Conventional Antibiotic Strategies Versus Regimens Guided by Epidemiological Surveillance in Infected Patients With Cirrhosis (SURVIC_STUDY)
Study to comparing conventrional antibiotic strategies versus regimens guided by epidemiological surveillance in infected patients with cirrhosis.
- Trial name
- SURVIC (NCT05783661)
- Testing
- Conventional antibiotic strategies, Regimens guided by epidemiological surveillance
- Where
- Spain
- Volunteers
- 198 people
- Sponsor
- Eva Bonfill
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
- 23 sites in United States, China and 6 more
- Volunteers
- 48 people
- Sponsor
- Pfizer
Bacterial Infection
Exposure to NSAIDs (Non Steroidal Anti-Inflammatory Drugs) and Severity of Community-acquired Bacterial Infections
NSAIDs are widely consumed, and some are currently available for self-medication with indications 'Pain and Fever' (Cavalié, National Agency for Drug Safety (ANSM), 2014) There is no recommendation to limit their use in bacterial…
- Trial name
- ANAIG (NCT02794831)
- Where
- France
- Volunteers
- 335 people
- Sponsor
- Nantes University Hospital
Bacterial Infections
Personalized Antibiotic Therapy - Point-of-Care Determination of Blood Levels of Beta-Lactam Antibiotics Using Coated-Blade-Spray Ion Mobility Spectrometry
A new analytical method for determining beta-lactam antibiotic concentrations in the blood of intensive care patients is to be evaluated.
- Trial name
- CBS-IMS (NCT07666230)
- Volunteers
- 200 people
- Sponsor
- Dr. T. Perl