Infectious Disease Research

We serve as principal investigators for clinical trials in Phases I, II, III and IV, with primary focus on trials in Phases III and IV, developing new medications, as well as new uses for existing medications.

 

The clinical trials that we conduct mainly involve new antimicrobials, antifungals and vaccines. Our basic science research is focused in the area of infection/inflammation with the goal of gaining a better understanding of the functions of the body while under attack of infection and in the bodyís resolution process. We are looking at responses to infection in multiple infectious syndromes, including UTIs, otitis media and infections in the neonate and premature infant. We hope to better manipulate the immune system to enhance recovery and decrease long-term sequalae mediated by inflammation. We are finalizing our grant with the NIH to become one of only six investigator sites nationwide to test two new anthrax vaccines.

 

For more information, please contact Ofelia Vargas, CCRC at (714) 532-8735.

 

Research Projects

 

A Multicentre, Double- Blind, Comparative, Randomised Study to Evaluate the Efficacy and Safety of Micafungin (FK463) versus Liposomal Amphotericin B (AmBisome ®) in the Treatment of Invasive Candidiasis and Candidaemia Protocol FG-463-21-08. July 2003-July 2006. Principal Investigator: Antonio Arrieta, MD. (Fujisawa Healthcare Inc.)

 

A Pivotal Phase 3 Study of MEDI-524 (Numax), an Enhanced Potency Humanized Respiratory Syncytial Virus (RSV) Monoclonal Antibody, for the Prophylaxis of Serious RSV Disease in High Risk Children. Protocol #: MI-CP110. August 2004-October 2006. Principal investigator: Gary Goodman, MD; Co-investigator: Antonio Arrieta, MD (MedImmune)

 

A prospective, open label, non –randomized, naturalistic, long term safety surveillance, observational study of ciprofloxacin (either as oral suspension, oral tablets, or sequential IV  oral therapy or purely IV therapy) in the treatment of pediatric patients with a variety of infectious diagnoses. Pediatric quinolone use in pediatrics (QUIP) STUDY. Protocol 100201. October 2000- 2009. Principal Investigator: Antonio Arrieta, MD. (Bayer)- closed to enrollment- follow up only

 

Investigator Initiated Safety and Efficacy of Liposomal Amphotericin B (LAM-B) for the Prevention of Invasive Candidiasis in Preterm Infants. November 2003- September 2008. Principal Investigator: Antonio Arrieta, MD (Fujisawa Healthcare Inc– closed to enrollment

 

IRB #050805 and IRB#070751 (Season 1 and Season 2)- A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), in Children with Hemodynamically Significant Congenital Heart Disease MI-CP-124. August 2005-October 2008. Principal Investigator: Gary Goodman, Co-investigator: Antonio Arrieta, MD (MedImmune)

 

A Prospective, Non-Interventional Study to Evaluate the Incidence of Hospitalizations and Medically-Attended Lower Respiratory Tract Infection (MALRI) in Premature Infants 32 to 35 Weeks Gestational Age Who Are Not Recommended to Receive Prophylaxis for RSV (MI-MA 140). October 2006- September 2007. Principal Investigator: Gary Goodman, MD; Co-investigator: Antonio Arrieta, MD (MedImmune)

 

Screening of Mannose-Binding Lectin (MBL) Status in Pediatric Hematology/Oncology Patients. Protocol EZN-2232-03-S. June 2007-July 2009. Principal Investigator: Antonio Arrieta, MD (Enzon Pharmaceuticals)

 

A Multi-Center Study of the Safety, Tolerability, Pharmacokinetics, and Dose Escalation of Intravenous Recombinant Human Mannose-Binding-Lectin (rhMBL) in MBL Deficient Pediatric Hematology/Oncology Patients with Fever and Neutropenia. Protocol EZN-2232-03. June 2007-July 2009. Principal Investigator: Antonio Arrieta, MD (Enzon Pharmaceuticals)

 

A Phase I, Open-Label Study of the Safety and Tolerability of Repeated-Dose Micafungin as Antifungal Prophylaxis in Children and Adolescents Undergoing Hematopoietic Stem Cell Transplant Protocol 9463-CL-2103. May 2007-July 2009. Principal Investigator: Antonio Arrieta, MD (Astellas Pharma US).

 

A Phase 2, Randomized, Double Blind, Placebo Controlled Study to Evaluate a
Single Intravenous Dose of Motavizumab (MEDI-524), a Humanized Enhanced Potency, Monoclonal Antibody to Respiratory Syncytial Virus (RSV) for the Treatment of Children Hospitalized with RSV illness. (MI-CP-141). July 2007- November 2008. Principal Investigator: Antonio Arrieta, MD (MedImmune)

 

A Phase 3, Randomized, Double-Blind, Multicenter Study to Compare the Efficacy and Safety of Micafungin versus Amphotericin B Deoxycholate for the Treatment of Neonatal Candidiasis (PROTOCOL 04-0-199/ISN 9463-CL-2303)- June 2006-closed to enrollment. Principal Investigator: Antonio Arrieta, MD (Astellas)

 

Expanded Access Protocol for VariZig. June 2006-present Principal Investigator: Jasjit Singh, MD; Sub investigator: Antonio Arrieta, MD (Astellas) (Cangene/FFF)

 

IRB Studies

 

IRB#060640- Phase II Safety and Immunogenicity Study of Quadrivalent Human Papillomavirus (Types 6, 11, 16 and 18) L1 Virus Like Particle (VLP) Vaccine (GARDASIL ®) in HIV infected Children > 7 to < 12 years of age. Protocol PACTG 1047. June 2006-closed to enrollment, patients in follow up. Principal Investigator: Antonio Arrieta, MD (PACTG)

 

IRB # 0611107- A Pharmacokinetic/Pharmacodynamic and Safety Evaluation of Oseltamivir (Tamiflu ®) for the Treatment of Children less than 24 months of age with Confirmed Influenza infection (CASG 114, DMID 06-0059). November 2006-2011. Principal Investigator: Negar Ashouri, MD; Sub investigator: Antonio Arrieta, MD (CASG-DMID)

 

IRB# 070211 – A Phase 1, Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin (FK463) in Infants and Toddlers (> 4 months to < 24 months of age) with Esophageal Candidiasis or Other Invasive Candidiasis. Protocol 9463-CL-2102. February 2007-2011. Principal Investigator: Antonio Arrieta, MD (Astellas Pharma US)

 

IRB#1010111 Emergency Use Protocol for CMX001 in a Bone Marrow Transplant Patient with AdV, BKV, and CMB disseminated Infections. October 2010-2011. Principal Investigator: Antonio Arrieta, MD (Chimerix)

 

IRB # 1012127 Emergency Use Protocol for CMX001 in a Bone Marrow Transplant Patient with AdV, and CMB disseminated Infections. December 2010-2011. Principal Investigator: Antonio Arrieta, MD (Chimerix)

 

CURRENT STUDIES – PEDIATRIC INFECTIOUS DISEASES CLINICAL RESEARCH (Ongoing Clinical Trials)

 

IRB# 070329- A Phase 1, Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin (FK463) in Children (2-5 Years and 6-11 Years) and Adolescents (12-16 Years) with Esophageal Candidiasis or Other Invasive Candidiasis. Protocol 9463-CL-2101- March 2007-present. Principal Investigator: Antonio Arrieta, MD (Astellas Pharma US)

 

IRB# 080101- Phase 1B Study of the Safety, Tolerance and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children with Neutropenia. Protocol P03579. January 2008-present. Principal Investigator: Antonio Arrieta, MD. (Schering-Plough).

 

IRB#80892 – International Fungal Network. August 2008-present. (International Fungal Network Coordinating Center)

 

IRB # 0809106- A Prospective, Open Label Study to Assess the Pharmacokinetics, Safety & Efficacy of Anidulafungin When Used to Treat Children with Invasive Candidiasis, Including Candidemia (Protocol A8851008). September 2008-present. Principal Investigator: Antonio Arrieta, MD (Pfizer)

 

IRB # 0810113- An Evaluation of the Safety, Efficacy, and Pharmacokinetics of Daptomycin in Pediatric Subjects Aged Seven to Seventeen Years with Complicated Skin and Skin Structure Infections Caused by Gram-Positive Pathogens (DAP-PEDS-07-03). October 2008-present. Principal Investigator: Antonio Arrieta, MD (Cubist)

 

IRB#90542 – An Open-Label, Multicenter, Multiple-Dose Pharmacokinetic Safety and Efficacy Trial of Maraviroc in Combination with Optimized Background Therapy for the Treatment of Antiretroviral-Experienced CCR5-Tropic HIV-1 Infected children 2-<18 years of age. May 2009-present. (Viiv Healthcare)

 

IRB#911113 An Evaluation of the Pharmacokinetic Profile and Safety of a Single Dose of Daptomycin in Pediatric Subjects Aged Three Months to Twenty-Four months Who are concurrently receiving standard antibiotic therapy for proven or Suspected Gram-positive infection. (Cubist Pharmaceuticals)

 

IRB #100211 An open label, prospective pharmacokinetic/pharmacodynamic and safety evaluation of intravenous oseltamivir (Tamiflu) in the treatment of infants less than one year of age with influenza infection. February 2010-present. (F. Hoffman-LaRoche LTD)

 

IRB # 100216 A Phase 1, Open-Label, Multi-Center, Two-Part, Single-Dose, Parallel Design, Safety, Tolerance, and Pharmacokinetic Study of Orally and Intravenously Administered TR-701 FA in 12 to 17 year Old Adolescent Patients. March 2010-present. (Trius Therapeutics)

 

IRB#100432 Safety and Efficacy of Micafungin for the Treatment and Prevention of Fungal Infections in Neonatal and Pediatric Patients at Children’s Hospital of Orange County. April 2010-present. (Astellas)

 

IRB#100435 Safety, Tolerability and Pharmacokinetics of Single Dose Intravenous Moxifloxacin in Pediatric Patients. (Bayer Healthcare)

 

IRB#100664 A Randomized, Double Blind Multicenter Trial to Evaluate the Safety and Efficacy of Sequential (Intravenous, oral) Moxifloxacin Versus Comparator in Pediatric Subjects with Complicated Intra-Abdominal Infection. July 2010-present. (Bayer Healthcare)

 

IRB#100771T Serum and Stool Calprotectin and Serum Lypopolysaccharide Binding Protein as Markers of Serious Infection and Necrotizing Enterocolitis in Premature Infants. August 2010-present. (PSF Tithe Committee)

 

IRB #110113 Prospective Surveillance to evaluate the Impact of the introduction of PREVNAR 13 on Streptococcus Pneumoniae invasive infections in Orange County, California. February 2011-present. (Pfizer)

 

IRB #110335 A Randomized, Placebo-controlled, Multi-Site Phase 2 Study Evaluating the Safety and Efficacy of Preemptive Treatment with CMX001 for the Prevention of Adenovirus Disease Following Hematopoietic Stem Cell Transplantation. April 2011-present. (Chimerix Inc.)

 

IRB #110337 Safety and Pharmacokinetics of Metronidazole in Premature Infants. April 2011-present. (Duke Clinical Research Institute)

 

IRB #110663 Treatment and Management of empyema at CHOC Children’s from 2000-2011. July 2011. (CHOC)

 

IRB#111088 Phase 3 SDIV ibuprofen vs. acetaminophen for fever reduction in children 0-16 years. (Cumberland Pharmaceuticals)