- Antifungal resistance and susceptibility
- Antibiotics Pharmacokinetics and Efficacy
- Pneumonia and Respiratory Infections
- Cystic Fibrosis Research Advances
- Fungal Infections and Studies
- Bacterial Infections and Vaccines
- Streptococcal Infections and Treatments
- Antimicrobial Resistance in Staphylococcus
- Neonatal and Maternal Infections
- Respiratory and Cough-Related Research
- Antibiotic Resistance in Bacteria
- Antibiotic Use and Resistance
- Pneumocystis jirovecii pneumonia detection and treatment
- Infective Endocarditis Diagnosis and Management
- Pharmaceutical studies and practices
- Mycobacterium research and diagnosis
- COVID-19 Clinical Research Studies
- Infant Nutrition and Health
- Neonatal Health and Biochemistry
- Pediatric Urology and Nephrology Studies
- Tuberculosis Research and Epidemiology
- Respiratory viral infections research
- Parasitic Diseases Research and Treatment
- Infectious Diseases and Tuberculosis
- Neonatal Respiratory Health Research
Children's Hospital of Orange County
2016-2025
University of California, Irvine
2014-2025
University of Puerto Rico System
2022-2024
Loma Linda University
2022
University of California, San Diego
2001-2016
Merck & Co., Inc., Rahway, NJ, USA (United States)
2016
Rady Children's Hospital-San Diego
2001-2016
Arkansas Children's Hospital
2016
Miller Children's & Women's Hospital
1991-2015
Astellas Pharma (Japan)
2014
In this double-blind study to compare safety of 2 lipid formulations amphotericin B, neutropenic patients with unresolved fever after 3 days antibacterial therapy were randomized (1:1:1) receive B complex (ABLC) at a dose 5 mg/kg/d (n=78), liposomal (L Amph) (n=85), or L Amph (n=81). (3 and mg/kg/d) had lower rates (23.5% 19.8% vs. 57.7% on day 1; P<.001), chills/rigors (18.8% 23.5% 79.5% nephrotoxicity (14.1% 14.8% 42.3%; P<.01), toxicity-related discontinuations (12.9% 12.3% 32.1%;...
Abstract A panel of experts was convened by the Infectious Diseases Society America (IDSA) to update 2004 clinical practice guideline on outpatient parenteral antimicrobial therapy (OPAT) [1]. This is intended provide insight for healthcare professionals who prescribe and oversee provision OPAT. It considers various patient features, infusion catheter issues, monitoring questions, stewardship concerns. does not offer recommendations treatment specific infections. The reader referred disease-...
Abstract This clinical practice guideline for the diagnosis and treatment of acute hematogenous osteomyelitis (AHO) in children was developed by a multidisciplinary panel representing Pediatric Infectious Diseases Society (PIDS) America (IDSA). is intended use healthcare professionals who care with AHO, including specialists pediatric infectious diseases, orthopedics, emergency physicians, hospitalists, any clinicians providers caring these patients. The panel’s recommendations AHO are based...
We conducted a multicenter study of the safety, tolerability, and plasma pharmacokinetics parenteral formulation voriconazole in immunocompromised pediatric patients (2 to 11 years old). Single doses 3 or 4 mg/kg body weight were administered six five children, respectively. In multiple-dose study, 28 received loading 6 every 12 h on day 1, followed by 2 8. Standard population pharmacokinetic approaches generalized additive modeling used construct structural covariate models this analysis....
ABSTRACT Micafungin (FK463) is a new parenteral echinocandin. A multicenter, phase I, open-label, sequential-group dose escalation study was conducted to assess the safety, tolerability, and pharmacokinetics of micafungin in neutropenic pediatric patients. total 77 patients stratified by age (2 12 13 17 years) received micafungin. Therapy initiated at 0.5 mg/kg per day escalated higher levels 1.0, 1.5, 2.0, 3.0, 4.0 day. administered within 24 h initiating broad-spectrum antibacterial...
Invasive candidiasis is increasingly prevalent in premature infants and seriously ill children, pediatric data on available antifungal therapies are lacking.We conducted a substudy as part of double-blind, randomized, multinational trial to compare micafungin (2 mg/kg) with liposomal amphotericin B (3 first-line treatment invasive candidiasis. Treatment success was defined clinical mycologic response at the end therapy. Statistical analyses were descriptive, sample size meant that study not...
Candida species are the third most common cause of pediatric health care-associated bloodstream infection in United States and Europe. To our knowledge, this report from International Pediatric Fungal Network is largest prospective, multicenter observational study dedicated to neonatal invasive candidiasis.From 2007 2011, we enrolled 196 25 patients with candidiasis.Non-albicans predominated (56%) (52%) age groups, yet albicans was both groups. Successful treatment responses were observed...
Background: Determining the safety and pharmacokinetics of antifungal agents in neonates is important. A previous single-dose pharmacokinetic study micafungin demonstrated that doses 0.75 to 3 mg/kg produced lower plasma concentrations than older patients because increased apparent clearance neonates. The primary objective this was assess an (15 mg/kg/d) dose micafungin. Methods: repeated dose, open-label pharmacokinetic, trial intravenous 12 preterm >48 hours life with suspected systemic...
Neonatal invasive candidiasis is associated with significant morbidity and mortality. We describe the association between changes in use of antifungal prophylaxis, empirical therapy, broad-spectrum antibacterial antibiotics over time.
The pharmacokinetics of voriconazole in children receiving 4 mg/kg intravenously (i.v.) demonstrate substantially lower plasma exposures (as defined by area under the concentration-time curve [AUC]) than those adults same therapeutic dosage. These differences between and limit accurate prediction pediatric exposure based on adult dosages. We therefore studied tolerability higher dosages an i.v.-to-oral regimen immunocompromised aged 2 to <12 years two dosage cohorts for prevention invasive...
Invasive candidiasis in premature infants causes death and neurodevelopmental impairment. Fluconazole prophylaxis reduces candidiasis, but its effect on mortality the safety of fluconazole are unknown.
Despite advances in cytomegalovirus (CMV) prophylaxis and therapy, some transplant recipients still develop refractory CMV infections. Maribavir (MBV), an investigational benzimidazole antiviral agent, acts by a mechanism different from that of existing anti-CMV drugs. Previous Phase I II studies have demonstrated favorable safety profile for MBV, but its utility treatment complex syndromes is unknown.Between June December 2008, MBV was released use under individual emergency new drug...
Preterm infants face health problems likely related to microbial exposures, including sepsis and necrotizing enterocolitis. However, the role of gut microbiome in preterm infant is poorly understood. Microbial colonization differs from that healthy term babies because it occurs NICU often perturbed by antibiotics. We measured bacterial compositions metabolomic profiles 77 fecal samples 32 investigate differences between microbiomes disease. Rather than finding signatures disease, we found...
ABSTRACT Micafungin is an echinocandin with potent activity against Candida spp. Hematogenous meningoencephalitis (HCME) a frequent complication of disseminated infection in premature infants. A preclinical model HCME suggests that micafungin may be effective agent for this syndrome, but relatively high weight-based dosages are required. This prompted the further study safety and pharmacokinetics (PK) Here, we describe population 47 infants proven or presumptive diagnosis candidiasis, who...
Abstract A panel of experts was convened by the Infectious Diseases Society America to update 2004 clinical practice guideline on outpatient parenteral antimicrobial therapy (OPAT) [1]. This is intended provide insight for healthcare professionals who prescribe and oversee provision OPAT. It considers various patient features, infusion catheter issues, monitoring questions, stewardship concerns. does not offer recommendations treatment specific infections. The reader referred disease- or...
The COVID-19 pandemic is a public health crisis that has the potential to exacerbate worldwide malnutrition. This study examines whether patients with history of malnutrition are predisposed severe COVID-19. To do so, data on 103,099 inpatient encounters from 56 hospitals in United States between March 2020 and June were retrieved Cerner Dataset. Patients 2015 2019 identified, random intercept logistic regression models for pediatric adult built controlling patient demographics,...
Abstract The epidemiology of invasive aspergillosis (IA) is evolving. To define the patient groups who will most likely benefit from primary or secondary Aspergillus prophylaxis, particularly those whose medical conditions and IA risk change over time, it helpful to depict populations their periods in a temporal visual model. Sankey approach provides dynamic figure understand for various populations. While depicted within this article static, an internet-based version could provide pop-up...
Given the risk of central nervous system infection, relatively high weight-based echinocandin dosages may be required for successful treatment invasive candidiasis and candidemia in young infants. This open-label study assessed safety pharmacokinetics (PK) micafungin 13 infants (>48 h <120 days life) with suspected or candidiasis. Infants body weight > =1,000 <1,000 g received 7 10 mg/kg/day, respectively, a minimum 4-5 days. In 7-mg/kg/day group, mean baseline gestational age were 2,101 30...
The echinocandins potentially have an important role in treatment of infections caused by Candida spp. and Aspergillus immunocompromised children. However, there are no population pharmacokinetic models the for pediatric patients. safety descriptive pharmacokinetics micafungin children were recently reported. a model is needed order to accurately determine dosage that produces equivalent magnitude drug exposure observed adults. In explore effect weight on pharmacokinetics, standard...
Suspected or complicated intra-abdominal infections are common in young infants and lead to significant morbidity mortality. Meropenem is a broad-spectrum antimicrobial agent with excellent activity against pathogens associated this population. The purpose of study was determine the pharmacokinetics (PK) meropenem as basis for optimizing dosing minimizing adverse events.Premature term <91 days old hospitalized 24 neonatal intensive care units were studied. Limited PK sampling performed...
Isavuconazole, administered as the water-soluble prodrug isavuconazonium sulfate, is a new triazole agent used to treat invasive fungal infections. This phase 1 study evaluated pharmacokinetics (PK), safety, and tolerability of isavuconazole in 46 immunocompromised pediatric patients, stratified by age (1 <6 [intravenous (i.v.) only], 6 <12, 12 <18 years), receiving 10 mg/kg body weight (maximum, 372 mg) sulfate either i.v. or orally.
Background. Intra-abdominal infections are common in young infants and lead to significant morbidity mortality. Meropenem is a broad-spectrum antimicrobial with excellent activity against pathogens associated intra-abdominal infections. The purpose of this study was determine the safety effectiveness meropenem suspected or complicated
This study aimed to investigate the pharmacokinetics (PK), safety, and tolerability of a single dose ceftazidime-avibactam in pediatric patients. A phase I, multicenter, open-label PK was conducted patients hospitalized with an infection receiving systemic antibiotic therapy. Patients were enrolled into four age cohorts (cohort 1, ≥12 <18 years; cohort 2, ≥6 <12 3, ≥2 <6 4, ≥3 months <2 years). received 2-h intravenous infusion 2,000 500 mg; mg [≥40 kg] or 50 12.5 mg/kg [<40 kg]; 3 mg/kg)....
Amphotericin B deoxycholate (AmB-D) is standard of care treatment for neonatal invasive candidiasis (IC). Micafungin (MCA) has broad-spectrum fungicidal activity against Candida spp. We compared the efficacy and safety intravenous MCA with AmB-D assessed pharmacokinetics in infants >2-120 days age proven IC a phase 3, randomized, double-blind, multicenter, parallel-group, noninferiority study (NCT00815516).Infants were randomized 2:1 to (10 mg/kg/d) or (1 ≥21 days. Primary endpoint was...
This clinical practice guideline for the diagnosis and treatment of acute bacterial arthritis (ABA) in children was developed by a multidisciplinary panel representing Pediatric Infectious Diseases Society (PIDS) America (IDSA). is intended use healthcare professionals who care with ABA, including specialists pediatric infectious diseases orthopedics. The panel's recommendations ABA are based upon evidence derived from topic-specific systematic literature reviews. Summarized below children....