Bacterial Infection Clinical Trial
Official title:
A Phase 1, Open-Label Study in Healthy Adults to Evaluate the Safety and Pharmacokinetics of AVYCAZ(R) in Combination With Aztreonam (COMBINE)
This is a Phase I, open-label, non-randomized, single center study in 48 healthy adult male and female subjects, aged 18 to 45 years. This study is aimed to investigate the safety and pharmacokinetics of ceftazidime-avibactam (AVYCAZ) combined with aztreonam (ATM), AVYCAZ alone, and ATM alone. The study will have 6 arms, arms 1-4 are the single drug administration treatment groups and will include AVYCAZ per label dosing, AVYCAZ as a continuous infusion (CI), ATM per label dosing, and ATM as a CI. Arms 5 and 6 are the two AVYCAZ and ATM combination drug administration treatment groups. The duration of subject participation will be up to 44 days, and the total length of the study will be 15 months. The primary objective of this study is to describe the safety of two dosing regimens of AVYCAZ combined with ATM relative to AVYCAZ alone, and ATM alone in healthy adult subjects.
This is a Phase I, open-label, non-randomized, single center study in 48 healthy adult male and female subjects, aged 18 to 45 years. This study is aimed to investigate the safety and pharmacokinetics of ceftazidime-avibactam (AVYCAZ) combined with aztreonam (ATM), AVYCAZ alone, and ATM alone. The study will have 6 arms, arms 1-4 are the single drug administration treatment groups and will include AVYCAZ per label dosing, AVYCAZ as a continuous infusion (CI), ATM per label dosing, and ATM as a continuous infusion (CI). Arms 5 and 6 are the two AVYCAZ and ATM combination drug administration treatment groups. The duration of subject participation will be up to 44 days, and the total length of the study will be 15 months. The primary objective of this study is to describe the safety of two dosing regimens of AVYCAZ combined with ATM relative to AVYCAZ alone, and ATM alone in healthy adult subjects. The secondary objectives of this study are to; 1) Characterize the PK profiles of two dosing regimens of AVYCAZ combined with ATM, AVYCAZ alone, and ATM alone at the population level in healthy adult subjects; 2) Characterize the PK profiles of two dosing regimens of AVYCAZ combined with ATM, AVYCAZ alone, and ATM alone following initiation of dosing on day 1 in healthy adult subjects; and 3) Characterize the PK profiles of two dosing regimens of AVYCAZ combined with ATM, AVYCAZ alone, and ATM alone following multiple daily dosing in healthy adult subjects. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02794831 -
Exposure to NSAIDs (Non Steroidal Anti-Inflammatory Drugs) and Severity of Community-acquired Bacterial Infections
|
||
| Active, not recruiting |
NCT02533609 -
Elimination of Antibiotics During Citrate-anticoagulated Continuous-veno-venous-haemodialysis
|
||
| Completed |
NCT01892358 -
Preventing Bacterial and Viral Infections Among Injection Drug Users
|
N/A | |
| Completed |
NCT01371656 -
Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation
|
Phase 3 | |
| Completed |
NCT01446289 -
Immune Response Induced by a Vaccine Against Group B Streptococcus and Safety in Pregnant Women and Their Offsprings
|
Phase 2 | |
| Completed |
NCT01059890 -
Cerebral Antibiotics Distribution After Acute Brain Injury
|
Phase 1 | |
| Completed |
NCT00389558 -
Antiseptic Use and Dressing Application
|
Phase 4 | |
| Completed |
NCT00760279 -
An Open Label Evaluation of the Pharmacokinetics and Safety of Single Dose Intravenous Azithromycin in Preterm Neonates
|
Phase 1 | |
| Completed |
NCT02311816 -
Increase in Procalcitonin Kinetics May be a Good Indicator of Starting Empirical Antibiotic Treatment in Critically Ill Patients
|
N/A | |
| Completed |
NCT01225042 -
The Effect of Probiotics on E. Coli Gastroenteritis
|
N/A | |
| Completed |
NCT00800488 -
Procalcitonin for Predicting Serious Bacterial Infection in Infants Less Than 3 Months
|
N/A | |
| Completed |
NCT00915213 -
Incidence of Antibiotic Resistant E.Coli in Patients Undergoing Repeat Prostate Biopsy
|
N/A | |
| Not yet recruiting |
NCT00765778 -
Mastering Hospital Antimicrobial Resistance and Its Spread Into the Community
|
N/A | |
| Terminated |
NCT00307099 -
Comparative Antibiotic Therapy for Subjects With Pulmonary Infiltrates in the ICU
|
Phase 3 | |
| Recruiting |
NCT04479657 -
Qingfei Granule for the Treatment of the Pediatric Acute Upper Respiratory Tract Infection With Bacterial Infection
|
Early Phase 1 | |
| Completed |
NCT03299894 -
Impact of qSOFA Calculation on the Timing of Antimicrobial Therapy in the Emergency Department
|
N/A | |
| Completed |
NCT01817075 -
Chlorhexidine Gluconate Cleansing in Preventing Central Line Associated Bloodstream Infection and Acquisition of Multi-drug Resistant Organisms in Younger Patients With Cancer or Undergoing Donor Stem Cell Transplant
|
Phase 3 | |
| Completed |
NCT01244698 -
Postoperative Antibiotic Requirements Following Immediate Breast Reconstruction
|
Phase 4 | |
| Completed |
NCT01250574 -
Neutrophil CD64 and Procalcitonin as Novel Biomarkers for Postoperative Infections
|
||
| Completed |
NCT01012089 -
Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease
|
N/A |