A5007993892- Antibiotic Resistance in Bacteria
- Antibiotics Pharmacokinetics and Efficacy
- Pneumonia and Respiratory Infections
- Diabetes Treatment and Management
- Urinary Tract Infections Management
- Cancer Immunotherapy and Biomarkers
- Advanced Breast Cancer Therapies
- Metabolism, Diabetes, and Cancer
- Pancreatic function and diabetes
- Cancer Treatment and Pharmacology
- Pediatric Urology and Nephrology Studies
- Antibiotic Use and Resistance
- Neonatal and Maternal Infections
- Epilepsy research and treatment
- Peptidase Inhibition and Analysis
- HER2/EGFR in Cancer Research
- Gallbladder and Bile Duct Disorders
- Gastric Cancer Management and Outcomes
- Cancer Genomics and Diagnostics
- Nosocomial Infections in ICU
- Appendicitis Diagnosis and Management
Pfizer (United Kingdom)
2018-2021
Boehringer Ingelheim (Germany)
2014
Bracknell and Wokingham College
2014
University of Leicester
2014
National Taiwan University
2006
Abstract Objectives To investigate pharmacokinetics (PK) and safety (primary objectives) efficacy (secondary objective) of the investigational monobactam/β-lactamase inhibitor combination aztreonam/avibactam in patients with complicated intra-abdominal infection (cIAI). Methods This Phase 2a open-label, multicentre study (NCT02655419; EudraCT 2015-002726-39) enrolled adults cIAI into sequential cohorts for 5–14 days treatment. Cohort 1 received an loading dose 500/137 mg (30 min infusion),...
Ceftazidime-avibactam is effective and well tolerated in adults with complicated urinary tract infection (cUTI), but has not been evaluated children cUTI.This single-blind, multicenter, active-controlled, phase 2 study (NCT02497781) randomized ≥3 months to <18 years cUTI (3:1) receive intravenous (IV) ceftazidime-avibactam or cefepime for ≥72 hours, subsequent optional oral switch. Total treatment duration was 7-14 days. Primary objective assessment of safety. Secondary objectives included...
Ceftazidime-avibactam plus metronidazole is effective in the treatment of complicated intra-abdominal infection (cIAI) adults. This single-blind, randomized, multicenter, phase 2 study (NCT02475733) evaluated safety, efficacy and pharmacokinetics ceftazidime-avibactam children with cIAI.Hospitalized (≥3 months to <18 years) cIAI were randomized 3:1 receive intravenous metronidazole, or meropenem, for a minimum 72 hours (9 doses), optional switch oral therapy thereafter total duration 7-15...
This exploratory analysis assessed efficacy and safety outcomes in patients with Gram-negative bacteremia treated ceftazidime-avibactam or comparator across five phase 3, randomized, controlled, multi-center trials adults complicated intra-abdominal infection (cIAI), urinary tract (cUTI)/pyelonephritis, hospital-acquired pneumonia (HAP), ventilator-associated (VAP). In each trial, RECLAIM 3 (cIAI; NCT01499290/NCT01726023), REPRISE (cIAI/cUTI; NCT01644643), RECAPTURE (cUTI;...
Ceftazidime–avibactam combines the established anti-pseudomonal cephalosporin, ceftazidime, with novel non-β-lactam β-lactamase inhibitor, avibactam. The aim of this study was to evaluate safety ceftazidime–avibactam in adults using pooled data from two phase II (NCT00690378, NCT00752219) and five III (NCT01499290, NCT01726023, NCT01644643, NCT01808093 NCT01595438/NCT01599806) clinical studies. Safety seven multicentre, randomised, active-comparator studies were by group at patient level for...
The recommended adult dose of ceftaroline fosamil is 600 mg q12h by 1 h intravenous (iv) infusion for 5–14 days in complicated skin and soft tissue infection (cSSTI) 5–7 community-acquired pneumonia (CAP). A dosage q8h 2 iv approved some regions cSSTI patients with Staphylococcus aureus where the MIC or 4 mg/L. This analysis compares safety profiles regimens. Safety data from six Phase III, randomized, double-blind clinical trials were collated into pool (ceftaroline n = 506; NCT01499277)...
Abstract Background: The combination of immune checkpoint modulators with chemotherapy improves efficacy compared alone in PD-L1+ advanced TNBC (IMpassion130; KEYNOTE-355). addition IPAT to paclitaxel (PAC) improved a phase 2 trial (LOTUS). Preliminary overall response rate (ORR) data from multicenter 1b study (NCT03800836) evaluating triplet IPAT, atezolizumab, and taxane showed promising anti-tumor activity similar patient population, irrespective PD-L1 status [Schmid, AACR 2019]. Here, we...
Abstract Background: Phase 3 trials (IMpassion130, KEYNOTE-355) have shown improved efficacy with the addition of immune checkpoint modulators to chemotherapy in PD-L1 +ve aTNBC. However, unmet need remains ~60% pts aTNBC who -ve tumors. Preliminary data from a multicenter phase 1b study (NCT03800836) evaluating safety and oral AKT inhibitor IPAT + atezo paclitaxel/nab-paclitaxel showed promising antitumor activity (73% confirmed objective response rate) irrespective status [Schmid, AACR...