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A summary of research studies

  1. A clinical study of safety and immunogenicity of Haemophilus influenzae conjugate vaccine (Hib-OMP) in children, sponsored by Merck & Co., Inc., 1987-1990.
  2. Double blind study of comparison of Loracarbef vs Penicillin G in the treatment of streptococcal pharyngitis, sponsored by Eli-Lilly Pharmaceuticals, 1988-1989.
  3. Nosocomial Infections in the Intensive Care Nursery, sponsored by Centers for Disease Control, 1990-1991.
  4. A Comparison of 2:1 Ampicillin/Sulbactam plus Optional Aminoglycoside vs. Ampicillin plus Clindamycin plus an Aminoglycoside in the Treatment of Intra-Abdominal Infections in Hospitalized Children, sponsored by Pfizer Pharmaceuticals, 1990-1992.
  5. A Comparison of 2:1 Ampicillin/Sulbactam in the Treatment of Periorbital and Facial Cellulitis of Bacterial Etiology in Hospitalized Children, sponsored by Pfizer Pharmaceuticals, 1990-1992
  6. A Comparison of 2:1 Ampicillin/Sulbactam versus Cefuroxime in the Treatment of Soft Tissue Infections in Hospitalized Children, sponsored by Pfizer Pharmaceuticals, 1990-1992.
  7. Prospective study of congenital syphilis, goals include efficacy of maternal treatment in prevention of neonatal syphilis, efficacy of current recommended penicillin regimen, longitudinal evaluation of serological, clinical and neurodevelopmental outcome of infants with congenital syphilis, and the relationship between congenital syphilis and HIV-infection, sponsored by Centers for Disease Control, 1990-1993.
  8. A study of the Safety, Tolerability and Immunogenicity of PedvaxHIB Haemophilus B Conjugate Vaccine, sponsored by Merck Sharp & Dohme, 1991-1992.
  9. Open Comparative Study of Fluconazole versus Amphotericin B in the Treatment of Life-Threatening Candida Infections in Pediatrics, sponsored by Pfizer Pharmaceuticals, 1992-1993.
  10. Open Noncomparative Study of Fluconazole for the Treatment of Serious but Not Life-Threatening Candida Infections in Children, sponsored by Pfizer Pharmaceuticals, 1992-1993.
  11. Single-Blind Randomized Comparative Study of Single Dose (IM) Ceftriaxone and a Ten-day Course (PO) of Amoxicillin/Clavulanate Potassium for the Treatment of Acute Otitis Media in Infants and Children, sponsored by Hoffman-LaRoche, 1993-1994.
  12. Single-Blind Randomized Comparative Study of Single Dose (IM) Ceftriaxone and a Ten-day Course (PO) of Penicillin V for the Treatment of Streptococcal Pharyngitis in Children, sponsored by Hoffman-LaRoche, 1994.
  13. A Cross-Sectional Comparison of Immunologic, Virologic, and Genetic Characteristics of HIV-1 Infected Pediatric Slow Progressors and Rapid Progressors, sponsored by The Pediatric AIDS Foundation, 1994.
  14. Determination of Protective Levels of Maternal Antibody Against Early-Onset Invasive Group B Streptococcal Disease in Neonates, sponsored by the National Institutes of Health, 1994-1999.
  15. Evaluation of the Effectiveness of Intrapartum Antibiotic Prophylaxis Against Early-Onset Neonatal Group B Streptococcal (GBS) Disease, sponsored by The National Institutes of Health, 1996.
  16. A Phase III Study of MEDI-493, a Humanized Respiratory Syncytial Virus Monoclonal Antibody for the Prophylaxis of Severe RSV Disease in Premature Infants and Infants with Bronchopulmonary Dysplasia, sponsored by Medimmune, 1996
  17. Phase III randomized Placebo Controlled Multicenter Trial to Assess the Safety & Efficacy of rBPI21 in the Adjunctive Treatment of Pediatric patients with Severe Meningococcal Disease, sponsored by XOMA, 1996-1998\
  18. Hospital-based Assessment of Serious Rotavirus Infection in the United States before Mass Immunization, Cost Burden of Disease Requiring Hospitalization, sponsored by The Center for Pediatric Research and Wyeth-Ayerst Research, 1997-2000.
  19. Linezolid in the Treatment of Community-Acquired Pneumonia in Patients Aged 12 Months to 17 Years: An Open-Label, Multicenter Study of Intravenously Administered Linezolid Followed by Orally Administered Linezolid, sponsored by Pharmacia & Upjohn, 1998-1999.
  20. A Randomized Comparative Study of Alatrofloxacin versus Ceftriaxone with Optional Vancomycin in Children with Bacterial Meningitis, sponsored by Pfizer Pharmaceuticals, 1998-1999.
  21. Non-Managed Care Emergency Department Assessment of Moderate to Severe Gastroenteritis Due to Rotavirus in Cincinnati and Oakland, sponsored by Wyeth-Ayerst Research, 1999-2000.
  22. Linezolid vs. Cefadroxil in the Treatment of Skin and Skin Structure Infections in Children, sponsored by Pharmacia & Upjohn, 2000-2001.
  23. Open-Label, Multicenter, Multiple-Dose, Phase III Study of the Population Pharmacokinetics of IV Synercid (7.5 MG/KG, Q8H) in 75 Pediatric Patients, sponsored by Aventis Pharmaceuticals, 2000-2005.
  24. A Prospective, Randomized Study to Compare Ciprofloxacin (either as Oral Suspension or as IV or Sequential IV to oral Suspension Therapy) versus Control Regimens (either Cefixime Oral Suspension, IV Ceftazidime, or Sequential IV Ceftazidime to PO Cefixime) in the Treatment of Pediatric Patients with Complicated Urinary Tract Infections or Pyelonephritis, sponsored by Bayer Pharmaceuticals, 2000-2002.
  25. Linezolid IV/PO vs. Vancomycin IV for the Treatment of Resistant Gram-Positive Bacterial Infections in Children, sponsored by Pharmacia & Upjohn, 2001.
  26. An Open, Randomized, Multicenter Study of the Safety, Tolerability and Immunogenicity of Frozen MMRV Given Concomitantly versus Nonconcomitantly with Other Pediatric Vaccines in Healthy Children 12 to 15 Months of Age, sponsored by Merck & Co., Inc., 2001.
  27. Safety and Efficacy of Pentavalent (G1, G2, G3, G4, and P1) Human-Bovine Reassortant Rotavirus Vaccine in Healthy Infants, sponsored by Merck & Co., Inc., 2001-2005.
  28. A Prospective, Multicenter, Double-Blind, Randomized, Comparative Study to Evaluate the Safety, Local Tolerability, and Clinical Outcome of Ertapenem Sodium (MK-0826) versus Ceftriaxone Sodium in Pediatric Patients with Complicated Urinary Tract Infection, Skin and Soft Tissue Infection or Community-Acquired Pneumonia, sponsored by Merck & Co., Inc., 2001-2004.
  29. A Prospective, Multicenter, Randomized, Open-Label, Comparative Study to Evaluate the Safety, Tolerability and Efficacy of Ertapenem Sodium (MK-0826) versus Ticarcillin/Clavulanate in the Treatment of Hospital-Acquired Pneumonia and Complicated Intra-Abdominal Infections in Pediatric Patients, sponsored by Merck & Co., Inc., 2001-2004.
  30. Detection and Identification of Infectious Pathogens Using Real-Time, Quantitative PCR with Clinical Specimens from Patients at Risk for Bacteremia or Fungemia, sponsored by Roche Molecular Diagnostics, 2002-2004.
  31. A Multicenter, Randomized, Open-Label, Comparative Study to Compare the Efficacy and Safety of Levofloxacin and Standard of Care Therapy in the Treatment of Children with Community-Acquired Pneumonia in the Hospitalized or Outpatient Setting, sponsored by Johnson & Johnson Pharmaceutical Research & Development, 2002-2004.
  32. A Multicenter, Long-Term, Active-Surveillance Study of Musculoskeletal Disorders That Occur After Initiating a Course of Levofloxacin or Non-Fluoroquinoline Therapy For Acute Infectious Diseases in Children Who Were Enrolled in Phase 3 Clinical Trials Involving Levofloxacin Therapy, sponsored by Johnson & Johnson Pharmaceutical Research & Development, 2002-2005.
  33. A Randomized, 2-Period, Multicenter, Double-Blind, Parallel-Group Study Comparing the Effects of Two Doses of Montelukast Granules and Placebo in the Treatment of Respiratory Symptoms Associated With Respiratory Syncytial Virus-Induced Bronchiolitis in Children Aged 3 to 24 Months, sponsored by Merck & Co., Inc., 2003-2005.
  34. A Phase IIIb, Open, Randomized, Controlled, Multicenter Study of the Immunogenicity and Safety of GlaxoSmithKline Biologicals’ Inactivated Hepatitis A Vaccine (Havrix®) [720 EI.U/0.5 mL dose] Administered on a 0, 6-month Schedule Concomitantly with Merck and Company, Inc. Measles-Mump-Rubella Vaccine (M-M-RII®) and Merck and Company, Inc. Varicella Vaccine (VARIVAX®) to Healthy Children 15 Months of Age, sponsored by GlaxoSmithKline Biologicals, 2003-2006.
  35. 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, sponsored by MedImmune, Inc., 2004-2006.
  36. A Randomized, Double-Blind Trial to Assess the Safety and Relative Efficacy of CAIV-T Against Inactivated Influenza Vaccine in Children 6-59 Months of Age, sponsored by MedImmune, Inc., 2004-2004.
  37. M5A10: Comparative Immunogenicity of Different Multivalent Component Pertussis Vaccine Formulations Based  on  a 5-component Acellular Pertussis Vaccine in Infants and Toddlers, sponsored by Sanofi Pasteur, 2005-2006.
  38. A Prospective, Non-Interventional Study to Evaluate the Incidence of Hospitalizations and Medically-Attended Lower Respiratory Tract Infection (MALRI) in Premature Infatns 32 to 35 Weeks Gestational Age Who Are Not Recommended to Receive Prophylaxis for RSV, sponsored by MedImmune, Inc., 2006-2007.
  39. A Phase III, Randomized, Multinational Study, Double-Blinded for the Immunogenicity and Consistency Evaluation  of 3 Hib-MenCY-TT Vaccine Lots and Single-Blinded and Controlled for the Evaluation of Safety and Immunogenicity  of GSK Biologicals’ Haemophilus Influenzae Type B and Neisseria Meningitidis Serogroups C and Y-tetanus Toxoid Conjugate Vaccine Combined (Hib-MenCY-TT) Compared to Monovalent Hib Vaccine in Healthy Infants at 2,4,6, and 12 to 15 Months of Age (103813/105067), sponsored by GlaxoSmithKline Biologicals, 2006-2009.
  40. An Observational Study of Pediatric Patients Who Participated in a Previous Respiratory Syncytial Virus (RSV)-Induced Bronchiolitis Study of Montelukast (Protocol MK-0476-374-00), sponsored by Merck & Co, Inc., 2007-2010.
  41. A Multicenter, Open-Label, Ascending Multiple-Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Tigecycline in Patients 8 to 11 Years of Age With Selected Serious Infections, sponsored by Wyeth-Ayerst Research, 2007-2010
  42. A Multi-Center Study to Evaluate the Safety and Immunogenicity of ProQuad™ Vaccine When Administered Concomitantly with Novartis Meningococcal ACWY Conjugate Vaccine to Healthy Toddlers, sponsored by Novartis Vaccines & Diagnostics, Inc., 2008-2011.
  43. Respiratory Distress of the Newborn and Its Relationship to Group B Streptococcal Colonization, grant from the National Institutes of Health & Child Development, 2008-2011.
  44. An Observational Prospective Study to Assess Respiratory Syncytial Virus (RSV) Respiratory Events Among  Premature Infants (32 to 35 Week Gestational Age)-Outcomes and Risk Tracking Study (The REPORT Study), sponsored by MedImmune, Inc., 2009-2010.
  45. Rotavirus Vaccine Effectiveness Project, grant from the Centers for Disease Control, 2010-2011.

Revised: Monday, January 23, 2012 2:55 PM

 

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