Clinical trials: Beta-lactam Antibiotics
Sepsis, Infection
BLOOM: Pragmatic Feasibility Trial
The goal of this study is to compare two different ways of dosing cefepime, an antibiotic for very sick patients - the usual approach to dosing or a new dosing method.
- Trial name
- NCT07287332
- Testing
- Up-front individualized dosing algorithm, Usual Care
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Mayo Clinic
Beta-lactam Antibiotics, Therapeutic Drug Monitoring
The OPTIMAL TDM Study: Determining Optimal Beta-lactam Plasma Concentrations Through Therapeutic Drug Monitoring
Little is known of beta-lactam antibiotics' true therapeutic plasma concentration range. The aims of this study are to define evidence-based, safe and effective upper and lower limits of the plasma concentrations of imipenem…
- Conditions
- Beta-lactam Antibiotics, Therapeutic Drug Monitoring, Toxicity, Efficacy
- Trial name
- OPTIMAL TDM (NCT03790631)
- Testing
- The study is observational.
- Where
- Switzerland
- Volunteers
- 771 people
- Sponsor
- University of Geneva, Switzerland
Intra-abdominal Infections
LYS228 PK, Clinical Response, Safety and Tolerability in Patients With Complicated Intra-abdominal Infection (cIAI)
The purpose of the study was to evaluate whether LYS228 can be developed for the treatment of complicated intra-abdominal infections.
- Trial name
- NCT03354754
- Testing
- LYS228, Standard of care therapy
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Novartis Pharmaceuticals
Cystic Fibrosis
A Study Comparing Continuous Infusion Antibiotics to Standard Treatment for Lung Infections in Cystic Fibrosis
Cystic fibrosis (CF) is an inherited disorder which results in increased thickness of secretions, especially in the lungs. By adulthood, the majority of patients with CF will have a bacteria living in their lungs, called…
- Trial name
- CISTIC (NCT01667094)
- Testing
- Intermittent, short infusion Ceftazidime, Continuous infusion Ceftazidime, Intermittent, short infusion Meropenem
- Where
- Australia
- Volunteers
- 50 people
- Sponsor
- The Alfred
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
Premature Rupture of Membranes, Enterobacteriaceae
Prevalence of Carriage of Extended-Spectrum Beta-Lactamase (ESBL)-Producing Enterobacteria in Preterm Premature Rupture of Membranes : A French Multicenter Cohort Study
This study looks at how common certain antibiotic-resistant bacteria (called extended-spectrum beta-lactamase-producing Enterobacteriaceae, or E-BLSE) are in pregnant women who experience premature breaking of their water before…
- Conditions
- Premature Rupture of Membranes, Enterobacteriaceae, Beta-Lactams, Drug Resistance, Bacterial
- Trial name
- NCT07200999
- Where
- France
- Volunteers
- 250 people
- Sponsor
- Centre Hospitalier de Saint-Denis
Acute Kidney Injury, Beta-Lactam Antibiotic Toxicity (Diagnosis)
Risk Factors and Machine Learning Model for Beta-Lactam Drugs Related Acute Kidney Injury
Acute kidney injury (AKI), also known as acute kidney failure (ARF), is a common and complex kidney disease in clinic and an important factor related to poor prognosis of patients in clinic.
- Trial name
- NCT05533606
- Testing
- Beta-Lactam Drugs
- Where
- China
- Volunteers
- 19,000 people
- Sponsor
- Qianfoshan Hospital
Bacterial Pneumonia
Comparative Study of Ceftaroline vs. Ceftriaxone in Adults With Community-Acquired Pneumonia
The purpose of the study is to determine if the antibiotic ceftaroline is safe and effective in the treatment of community-acquired pneumonia in adults.
- Trial name
- CAP (NCT00509106)
- Testing
- Ceftaroline fosamil for Injection, Ceftriaxone
- Where
- 134 sites in United States, Argentina and 13 more
- Volunteers
- 622 people
- Sponsor
- Forest Laboratories
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN
This phase II trial studies the effect of imipenem-relebactam in treating patients with cancer who have a fever due to low white blood cell counts (febrile neutropenia).
- Trial name
- NCT04983901
- Testing
- Imipenem/Cilastatin/Relebactam, Cefepime, Meropenem
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- M.D. Anderson Cancer Center
Gram-Negative Infections
Extended-infusion of Piperacillin-Tazobactam Versus Intermittent Infusion
Continuous-infusion of piperacillin/tazobactam over 4 hrs instead of 30-minute intermittent dosage regimen has shown observable outcomes.
- Trial name
- NCT04895657
- Testing
- Piperacillin/Tazobactam Continuous infusion, Piperacillin/Tazobactam Intermittent infusion
- Where
- Egypt
- Volunteers
- 56 people
- Sponsor
- Ain Shams University
Beta Lactam Allergy, Hematologic Malignancy
Allergy Delabeling in Antibiotic Stewardship - Intervention
The overall goal of the RENEW-IN intervention is to assess the impact of a BL allergy delabeling intervention on antibiotic use and clinical outcomes in patients with a hematologic malignancy.
- Trial name
- RENEW-IN (NCT07133074)
- Testing
- RENEW-IN Algorithm for assessment of a beta-lactam intervention, EMR Review
- Where
- United States
- Volunteers
- 3,800 people
- Sponsor
- Abramson Cancer Center at Penn Medicine
Pediatric Critical Illness, Critical Illness
Tissue Penetration of Antibiotics in CriTically Ill Children
This clinical study evaluates the extent to which three commonly administered beta-lactam antibiotics (piperacillin-tazobactam, meropenem, and amoxicillin-clavulanic acid) penetrate tissue in critically ill pediatric patients.
- Trial name
- TACTIC (NCT07822243)
- Testing
- Pharmacokinetic sampling (Microdialysis and blood sampling)
- Where
- Belgium
- Volunteers
- 60 people
- Sponsor
- University Hospital, Ghent
Febrile Neutropenia
Efficacy of Extended Infusion of β-lactam Antibiotics for the Treatment of Febrile Neutropenia in Hematologic Patients
This study evaluates the administration of beta-lactam antibiotics in extended infusion in hematological patients with febrile neutropenia after 5 days of treatment.
- Trial name
- BEATLE (NCT04233996)
- Testing
- Piperacillin-Tazobactam 4 g-0.5 g, Cefepime 2000 mg, Meropenem 1000 mg
- Where
- Spain
- Volunteers
- 150 people
- Sponsor
- Hospital Universitari de Bellvitge
Osteomyelitis of Lower Extremities, Osteomyelitis - Foot
Comparison of Oral Antibiotics For Bone Infections of the Leg and Foot
The goal of this clinical trial is to compare different classes of oral antibiotics (beta-lactam and non-beta-lactam antibiotics) for the treatment of bone infections of the leg and foot.
- Conditions
- Osteomyelitis of Lower Extremities, Osteomyelitis - Foot, Osteomyelitis of the Foot
- Trial name
- OSTEO (NCT07266753)
- Testing
- Oral Beta-Lactam Antibiotic, Oral Non-Beta-Lactam Antibiotic
- Where
- 3 sites in Canada
- Volunteers
- 1,418 people
- Sponsor
- Michael Garron Hospital
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
Sepsis
Beta-lactam Intermittent Versus Continuous Infusion and Combination Antibiotic Therapy in Sepsis
Patients hospitalized in ICU with sepsis (infection with life-threatening organ dysfunction according to sepsis 3.0 definitions) or septic shock presumably due to MDR-GNB (multidrug resistant Gram-negative bacteria).
- Trial name
- BICCS (NCT05681442)
- Testing
- continuous pivotal βL-AB, intermittent pivotal βL-AB, AG infusion most 1 dose
- Where
- 26 sites in France
- Volunteers
- 600 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Acute Graft-Versus-Host Reaction Following Bone Marrow Transplant, Prevention of CDI in Adult Patients Being Treated With IV Beta-lactam Antibiotics
SYN-004 Safety and Tolerability in Allo-HCT Subjects
Study Objectives: 1. To evaluate the safety and tolerability of oral SYN-004 in adult allogeneic HCT (allo-HCT) recipients who develop fever after conditioning therapy and are treated with IV β-lactam antibiotics meropenem (MER)…
- Trial name
- NCT04692181
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Theriva Biologics, Inc.
Lower Respiratory Tract Infection
Approach for Optimizing Meropenem Therapy in Intubated and Mechanically-Ventilated, Adult Patients With Severe Gram-Negative Lower Respiratory Tract Infection
Antibacterial drugs are facing increasing limitations in terms of effectiveness due to emergence resistance. Improved antibacterial drug monitoring approaches are particularly needed in nosocomial infections occurring in ICU…
- Trial name
- MON4STRAT (NCT03915236)
- Testing
- MON4STRAT Strategy, Control group
- Where
- 3 sites in Belgium, France and 1 more
- Volunteers
- 7 people
- Sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Beta-Lactams Allergy, Hypersensitivity
Genomic Study of Genetic Polymorphisms Involved in Immediate Allergic Reactions to Beta-lactam Antibiotics
Beta-lactam antibiotics include penicillin and cephalosporins and are among the most prescribed antibiotics. This category of drugs is the most involved in immediate allergic manifestations with 2% reactions in treated subjects…
- Trial name
- PANGENOMIC-BL (NCT02895646)
- Testing
- Collection of blood sample
- Volunteers
- 2,356 people, healthy volunteers welcome
- Sponsor
- Central Hospital, Nancy, France
Sinusitis, Bronchitis, Chronic
Outcomes of Patients Not Responding to Antibiotics in the Community
A study to report the outcomes of patients who fail to respond to beta-lactam and macrolide antibiotics in the community
- Conditions
- Sinusitis, Bronchitis, Chronic, Pneumonia, Bacterial
- Trial name
- NCT00245427
- Testing
- all macrolide antibiotics, all beta-lactam antibiotics
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- CPL Associates