Clinical trials: Pediatric Infectious Disease
Cystic Fibrosis
Aztreonam Lysine for Pseudomonas Infection Eradication Study
This is an open-label, multi-center study in pediatric patients age 3 months to less than 18 years with cystic fibrosis (CF) and newly detected Pseudomonas aeruginosa (PA) pulmonary colonization/infection.
- Trial name
- ALPINE (NCT01375049)
- Testing
- Aztreonam for Inhalation Solution (AZLI)
- Where
- 58 sites in United States, Austria and 7 more
- Volunteers
- 105 people
- Sponsor
- Gilead Sciences
Infectious Diseases
BAY 0 9867 Cipro Pediatric Use Study (QUIP)
Objective and subjective musculoskeletal evaluations will be performed to determine differences in the ciprofloxacin versus non-quinolone treated pediatric patients so that we can tell what the natural occurrence of such…
- Trial name
- NCT00761462
- Testing
- Ciprofloxacin, Non-quinolone antibiotic
- Where
- 67 sites in United States, Canada
- Volunteers
- 1,029 people
- Sponsor
- Bayer
Malaria, HIV Infections
HIV Protease Inhibitors for the Prevention of Malaria in Ugandan Children
HIV and malaria are major causes of morbidity and mortality in Sub-Saharan Africa and children bear the greatest brunt of both diseases. No single existing intervention is likely to control malaria in Africa.
- Trial name
- PROMOTE-PEDS (NCT00978068)
- Testing
- Lopinavir/Ritonavir (LPV/r), Nevirapine (NVP), Efavirenz (EFV)
- Where
- Uganda
- Volunteers
- 176 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Influenza, Human
Safety Study to Assess IV Zanamivir for Treatment of Influenza Infection in Patients Who Are in Hospital
The purpose of this study is to determine whether zanamivir aqueous solution given by intravenous injection is safe in treating hospitalized patients with confirmed influenza infection.
- Trial name
- NCT01014988
- Testing
- zanamivir aqueous solution
- Where
- 110 sites in United States, Australia and 11 more
- Volunteers
- 202 people
- Sponsor
- GlaxoSmithKline
Clostridium Difficile Infection
Effect of Acid Suppression Medication on Pediatric Microbiome
The colonic microbiome is essential in health and disease, and is highly dynamic during the first several years of life. Proton pump inhibitors (PPIs) and histamine-2 receptor antagonists (H2RAs) are widely used in children, but…
- Trial name
- NCT02016820
- Testing
- Omeprazole (suspension), Lifestyle Modification
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Columbia University
Infectious Gastroenteritis
Implementation of a Molecular Diagnostic for Pediatric Acute Gastroenteritis: The FilmArray GI Panel IMPACT Study
BioFire Diagnostics, LLC (BioFire) has developed the FilmArray Gastrointestinal (GI) Panel, a rapid, easy to use PCR-based in vitro diagnostic test for the identification of 22 common microorganisms responsible for infectious…
- Trial name
- IMPACT (NCT02248285)
- Testing
- FilmArray™ Gastrointestinal (GI) Panel
- Where
- 5 sites in United States
- Volunteers
- 1,545 people
- Sponsor
- BioFire Diagnostics, LLC
Tinea Corporis
Safety and Efficacy of Product 33525 (Luliconazole Cream 1%) in Pediatric Participants With Tinea Corporis
The objective of this study was to evaluate the safety, efficacy, and pharmacokinetics of luliconazole cream 1% when applied topically for 7 days in pediatric participants 2 years to 17 years of age (inclusive) with tinea…
- Trial name
- NCT02767947
- Testing
- Luliconazole Cream 1%, Vehicle Cream
- Where
- 3 sites in Dominican Republic, Honduras
- Volunteers
- 75 people
- Sponsor
- Bausch Health Americas, Inc.
Hepatitis C
An Open-Label Study of the Effect of Telaprevir in Combination With Peginterferon Alfa-2b and Ribavirin in Pediatric Subjects Infected With Hepatitis C Virus
The purpose of this study is to assess the safety, efficacy, and pharmacokinetics in a carefully monitored cohort of pediatric subjects infected with hepatitis C virus (HCV) on a telaprevir-based regimen in Part A and with dose…
- Trial name
- NCT01701063
- Testing
- Telaprevir, Peginterferon alfa-2b, Ribavirin
- Where
- 23 sites in United States, Belgium and 4 more
- Volunteers
- 42 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Adenovirus Infection
Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation
This study will assess the safety and efficacy of Posoleucel for the treatment of adenovirus (AdV) infection in pediatric and adult allo-HCT recipients receiving standard of care (SoC).
- Trial name
- NCT05179057
- Testing
- Posoleucel
- Where
- 47 sites in United States, Canada and 4 more
- Volunteers
- 57 people
- Sponsor
- AlloVir
Hepatitis C, Chronic
Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P07614)
This is a study to determine the pharmacokinetics (PK) and weight-based dose of boceprevir following single oral dose administration in Chronic Hepatitis C Virus (HCV) pediatric participants.
- Trial name
- NCT01425190
- Testing
- Boceprevir
- Volunteers
- 16 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV Infections
Pharmacokinetics and Safety Study of Tipranavir in Combination With Low Dose Ritonavir in Human Immunodeficiency Virus (HIV)-Infected Children
The primary objective of this study is to assess the safety and tolerability of tipranavir (TPV) oral formulation and soft gelatin capsules together with low-dose ritonavir in HIV-infected children and adolescents, to provide…
- Trial name
- NCT00076999
- Testing
- TPV oral solution, RTV oral solution
- Where
- 30 sites in United States, Argentina and 8 more
- Volunteers
- 115 people
- Sponsor
- Boehringer Ingelheim
Gram-negative Bacterial Infections, Bloodstream Infections (BSI)
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants
The primary objectives of this study are: To assess the safety and tolerability of cefiderocol after single-dose administration in hospitalized paediatric participants 3 months to < 18 years of age with suspected or confirmed…
- Conditions
- Gram-negative Bacterial Infections, Bloodstream Infections (BSI), Complicated Intra-abdominal Infection (cIAI), Hospital Acquired Pneumonia (HAP)
- Trial name
- NCT04335539
- Testing
- Cefiderocol, Standard of Care
- Where
- 23 sites in Belgium, Estonia and 7 more
- Volunteers
- 53 people
- Sponsor
- Shionogi
HIV Infection
A Clinical Study Of An Investigational Regimen Including Marketed HIV Drugs In HIV-1 Pediatric Subjects Ages 2-18 Years
This is a 48-week study to collect additional information on the safety, tolerability, pharmacokinetics, and antiviral activity of an investigational regimen (course of therapy) including FDA approved HIV drugs in HIV-infected…
- Trial name
- NCT00040664
- Testing
- ritonavir, fosamprenavir
- Where
- 42 sites in United States, Canada and 5 more
- Volunteers
- 69 people
- Sponsor
- ViiV Healthcare
Nosocomial Infections
Study of Bathing With Chlorhexidine Impregnated Cloths on Nosocomial Infections in the Pediatric Intensive Care Unit
The investigators propose to conduct a large clinical study to determine if daily bathing with chlorhexidine impregnated cloths will reduce the incidence of healthcare-associated infections in the Pediatric Intensive Care Unit…
- Trial name
- NCT00549393
- Testing
- 2% Chlorhexidine gluconate cloth
- Where
- 5 sites in United States
- Volunteers
- 5,659 people
- Sponsor
- Johns Hopkins University
Meningococcal Meningitis, Measles
Immunogenicity and Safety of Pediatric Vaccines When Administered With Menactra® in Healthy Toddlers
This is a modified single-blind, randomized, parallel-group, comparative, multicenter study to test Menactra vaccine in toddlers.
- Conditions
- Meningococcal Meningitis, Measles, Mumps, Rubella
- Trial name
- NCT00422292
- Testing
- Meningococcal Polysaccharide Diphtheria Conjugate Vaccine, Measles, Mumps, Rubella and Varicella
- Where
- 88 sites in United States, Puerto Rico
- Volunteers
- 1,664 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Hepatitis C Virus Infection
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed Dose Combination in the Treatment of Hepatitis C Virus (HCV) Infection in Pediatric Participants Undergoing Cancer Chemotherapy
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) in treating hepatitis C virus (HCV) infection in pediatric participants who are undergoing cancer…
- Trial name
- NCT02868242
- Testing
- LDV/SOF
- Where
- Egypt
- Volunteers
- 19 people
- Sponsor
- Gilead Sciences
Skin Diseases, Infectious
Safety and Efficacy Study of Daptomycin in Pediatric Participants (1 to 17 Years-old) With Skin and Skin Structure Infections
This is a multi-center, evaluator-blinded, randomized, comparative study designed to assess the safety, efficacy, and pharmacokinetics (PK) of daptomycin in pediatric subjects ages 1 to 17 years, inclusive, with complicated skin…
- Trial name
- NCT00711802
- Testing
- Daptomycin, Standard of Care (SOC)
- Where
- 30 sites in United States, India and 1 more
- Volunteers
- 396 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Herpes Simplex
Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection
This study will evaluate the safety and blood levels of a new pediatric formulation of Famvir in children 1-12 years of age. In Part A, patients will receive a single dose of famciclovir (12.5 mg/kg) to assess pharmacokinetics…
- Trial name
- NCT00098059
- Testing
- Famciclovir
- Where
- 13 sites in United States, Panama
- Volunteers
- 74 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Hepatitis B
Safety and Efficacy of Adefovir Dipivoxil in Children and Adolescents With Chronic Hepatitis B
The purpose of this study is to investigate the efficacy and safety of adefovir dipivoxil for the treatment of chronic hepatitis B in children and adolescents (age 2 to less than 18 years) following 48 weeks of…
- Trial name
- NCT00095121
- Testing
- Adefovir Dipivoxil (ADV), Lamivudine
- Where
- United States
- Volunteers
- 173 people
- Sponsor
- Gilead Sciences
HIV Infections
Safety and Effectiveness of Emtricitabine, Efavirenz, and Didanosine in HIV Infected Children Who Have Taken Few or No Anti-HIV Drugs
Treatment of HIV-infected patients involves combining drugs from different classes of anti-HIV drugs. One preferred regimen for adults is 2 nucleoside reverse transcriptase inhibitors (NRTIs) and 1 protease inhibitor (PI).
- Trial name
- NCT00016718
- Testing
- Didanosine (ddI), Efavirenz (EFV), Emtricitabine (FTC)
- Where
- 18 sites in United States, Puerto Rico
- Volunteers
- 43 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)