Clinical trials: Antibiotic Side Effect, active
Sepsis, Sepsis Bacterial
Molecular Culture for the Diagnosis of Pediatric Sepsis
Babies and children have an increased risk of getting an infection with a bacteria in the bloodstream (sepsis). It is often difficult for the doctor to determine whether a child has an infection of the bloodstream, because the…
- Conditions
- Sepsis, Sepsis Bacterial, Sepsis, Neonatal, Infection, Bacterial
- Trial name
- CHAMPIONS (NCT06018792)
- Testing
- Molecular Culture
- Where
- 2 sites in Netherlands
- Volunteers
- 1,835 people
- Sponsor
- Jip Groen
Urinary Tract Infections, Antiobiotic Stewardship
Post-Emergency Optimization of Antibiotic Therapy for Urinary Tract Infection (UTI)
Prospective, multicenter, non-interventional study conducted over 6 months, including patients presenting to the emergency department with suspected urinary tract infection managed as outpatients and discharged with or without…
- Conditions
- Urinary Tract Infections, Antiobiotic Stewardship, Emerging Infectious Disease
- Trial name
- REVIU48 (NCT07559318)
- Testing
- Adaptation of antibiotics therapy for outpatient urinary infection following emergency care
- Where
- 3 sites in France
- Volunteers
- 330 people
- Sponsor
- Centre Hospitalier Intercommunal Creteil
Adverse Effects in the Therapeutic Use of Other and Unspecified Agents Affecting Blood Constituents
Antibiotic Concentrations After MassivE Transfusion Study
Combat and civilian trauma frequently result in open wounds that are at risk for infection. Data from the Department of Defense Trauma Registry demonstrate that 74% of combat trauma casualties have an open wound.
- Trial name
- ACME (NCT06699901)
- Testing
- Massive Transfusion Group, Control Group
- Where
- 2 sites in United States
- Volunteers
- 417 people
- Sponsor
- Brooke Army Medical Center
Drug Related Side Effects and Adverse Reactions, Infusion Reactions
Retrospective Kinetic Safety Evaluation of an Intravenous Micellar Excipient Platform
Protocol PICO-RWE-001: The goal of this observational study is to evaluate the kinetic safety and tolerability of an investigational intravenous micellar delivery platform.
- Trial name
- NCT07609069
- Testing
- PIV-850 (850-picometer Dual-NCE Acidic Matrix), Legacy Heterogeneous Payload (Micellar Vehicle)
- Where
- United States
- Volunteers
- 625 people
- Sponsor
- PICO IV, Inc.
Infections, Bacterial, Pharmacokinetics
Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment
The primary aim of the study is to determine the proportion of individuals receiving beta-lactam antibiotics at Imperial College Healthcare NHS Trust in whom drug concentration targets are achieved.
- Conditions
- Infections, Bacterial, Pharmacokinetics, Drug Monitoring, Drug-Related Side Effects and Adverse Reactions
- Trial name
- DATATDM (NCT06427317)
- Where
- United Kingdom
- Volunteers
- 323 people
- Sponsor
- Imperial College London
Drug-Related Side Effects and Adverse Reactions, Treatment Adherence and Compliance
Compliance and Tolerance to Oral AntiBiotherapy in Osteoarticular Infections (OTABIO)
Bone and joint infections (BJI) are most often bacterial infections that can occur after surgery or de novo. They are rarely fatal in the short term, but are associated with significant morbidity, impaired quality of life and…
- Trial name
- OTABIO (NCT05202964)
- Testing
- Tolerance and adherence to oral antibiotics in patients managed for BJI
- Where
- France
- Volunteers
- 60 people
- Sponsor
- Hospices Civils de Lyon
Microbial Colonization, Antibiotic Side Effect
Autoflor -Lyophilized Capsulated Autological FMT to Restore Gut Microbiome After Treatment With Antibiotics
In this clinical trial, our aim is to assess the effect of auto-FMT (Fecal microbiome transplantation) on the intestinal microbiota, after a course of antibiotics. 30 healthy adults are recruited.
- Trial name
- FMT (NCT06250413)
- Testing
- FMT, Amox Clav
- Where
- Finland
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Otto Helve
Antibiotic Side Effect
Evaluation of Bifidobacterium Breve PRL2020 in Preventing Antibiotic-Associated Side Effects From Amoxicillin or Amoxicillin/Clavulanic Acid
This study aims to evaluate the efficacy and safety of the probiotic Bifidobacterium breve PRL2020 in preventing gastrointestinal and extra-intestinal side effects caused by Amoxicillin or Amoxicillin/Clavulanic Acid in pediatric…
- Trial name
- NCT06850714
- Testing
- Bifidobacterium breve PRL2020 (Brevicillin®), Amoxicillin or Amoxicillin/Clavulanic Acid
- Where
- Italy
- Volunteers
- 800 people
- Sponsor
- Liaquat University of Medical & Health Sciences
Infections, Infected Wound
PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation
This is a Phase III clinical randomized control trial to investigate differences between patient with an infected nonunion treated by PO vs. IV antibiotics.
- Conditions
- Infections, Infected Wound, Nonunion of Fracture, Injury Leg
- Trial name
- POvIV2 (NCT05699174)
- Testing
- Standard of Care PO (oral) antibiotics, Standard of Care Intravenous (IV) antibiotics
- Where
- 13 sites in United States
- Volunteers
- 250 people
- Sponsor
- Major Extremity Trauma Research Consortium
Antibiotic Allergy
Support Tool for Antibiotic Allergy deLabeling
Antibiotic allergy labels (AAL) are reported in 7% of inpatient's charts, especially for beta-lactams (86% of AAL, i.e., prevalence of 6%).
- Trial name
- STAAL (NCT06771440)
- Testing
- EPR search
- Where
- Belgium
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Acute Kidney Injury, Adverse Drug Event
Melatonin for Prevention of Kidney Injury
This study will evaluate the safety and effectiveness of melatonin for the prevention of antibiotic associated acute kidney injury in hospitalized patients.
- Trial name
- NCT05084196
- Testing
- Melatonin
- Where
- 2 sites in United States
- Volunteers
- 300 people
- Sponsor
- Rutgers, The State University of New Jersey
Head and Neck Neoplasms, UADT Neoplasm
Post-Operative Antibiotic Efficacy in Clean Contaminated Head and Neck Surgery: A Randomized Controlled Trial
The "Post-Operative Antibiotic Efficacy in Clean Contaminated Head and Neck Surgery" (PEACH) trial is a study designed to assess the necessity of post-operative antibiotics for preventing surgical site infections (SSIs) in…
- Conditions
- Head and Neck Neoplasms, UADT Neoplasm, Cancer of the Head and Neck, Antibiotic Resistant Infection
- Trial name
- PEACH (NCT06672471)
- Testing
- No Post Operative Antibiotics for intervention group, Post Operative Antibiotics for one day
- Where
- Pakistan
- Volunteers
- 170 people
- Sponsor
- Shaukat Khanum Memorial Cancer Hospital & Research Centre
Implant Complication, Implant Infection
Local Antibiotics for Breast Implants
The BREAST-AB Trial is a multi-center, randomized, double blind, placebo-controlled trial investigating the efficacy of local application of gentamicin, vancomycin and cefazolin in decreasing all-cause implant explantation after…
- Conditions
- Implant Complication, Implant Infection, Implant Site Infection, Implant Capsular Contracture
- Trial name
- BREAST-AB (NCT04731025)
- Testing
- Gentamicin, Cefazolin and Vancomycin
- Where
- 8 sites in Denmark
- Volunteers
- 1,003 people, healthy volunteers welcome
- Sponsor
- Mikkel Herly
Drug Allergy, Cephalosporin Allergy
Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing
Cephalosporin antibiotics are commonly used but can result in allergic reactions and anaphylaxis. There is no clear diagnostic approach for cephalosporin-allergic patients, and guidance for the use of other antibiotics in…
- Conditions
- Drug Allergy, Cephalosporin Allergy, Drug Hypersensitivity, Antibiotic Allergy
- Trial name
- DACAT (NCT06406114)
- Testing
- Beta-lactam antibiotic (cefazolin, cefuroxime, cefotaxime, ceftazidime, ceftriaxone, cefepime, pre-pen, penicillin G, ampicillin, and histamine) double-blind skin testing
- Where
- 6 sites in United States
- Volunteers
- 300 people
- Sponsor
- Massachusetts General Hospital