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
Varicella
Safety and Efficacy of Varicella Zoster Immune Globulin (Human) VariZIG in Patients at Risk of Varicella Infection
This study is to assess VariZIG™ for the treatment of patients at risk for developing serious complications from chicken pox.
- Trial name
- NCT00338442
- Testing
- VariZIG™
- Sponsor
- Cangene Corporation
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
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
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
Diphtheria, Pertussis
Study of PR5I, a Pediatric Combination Vaccine With Enhanced Hepatitis B Component Given Concomitantly With Prevnar®
PR5I, a hexavalent pediatric combination vaccine is being developed to reduce the number of injections during the first 2 years of life while providing a complete course of immunization against infection caused by H.
- Conditions
- Diphtheria, Pertussis, Polio, Hepatitis B
- Trial name
- NCT00362427
- Testing
- Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC
- Where
- 8 sites in Canada
- Volunteers
- 460 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Infection, Bacterial, Infection Viral
Access MeMed BV Assay Clinical Study Collection Protocol - Infectious Adult and Pediatric Cohorts
The purpose of the pivotal study is to collect blood specimens and clinical data from pediatric (>90 days old) and adult (≥18 years old) patients presenting with signs and symptoms suggestive of acute bacterial or viral…
- Trial name
- NCT06379061
- Testing
- Adult and Pediatrics
- Where
- 4 sites in United States
- Volunteers
- 650 people
- Sponsor
- Beckman Coulter, Inc.
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
Human Immunodeficiency Virus Type 1
A Roll-over Study With Rilpivirine for Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Who Participated in Rilpivirine Pediatric Studies
The purpose of this study is to provide continued access to rilpivirine (RPV) for participants who were treated with RPV in a clinical development pediatric study with rilpivirine and who, at the time of roll-over, experience and…
- Trial name
- NCT02494986
- Testing
- Rilpivirine
- Where
- 8 sites in Portugal, South Africa and 3 more
- Volunteers
- 48 people
- Sponsor
- Janssen Sciences Ireland UC
Skin Diseases, Infection
Study Evaluating Tigecycline Versus Clindamycin Or Vancomycin On Complicated Skin And Skin Structure Infections Including Those Due To Methicillin-Resistant Staphylococcus Aureus (MRSA) In Pediatric Subjects
The main purpose of this study is to compare the safety and efficacy of tigecycline versus clindamycin (including subjects treated with vancomycin) in pediatric subjects (aged 8 to 17 years) with complicated skin and skin…
- Trial name
- NCT00911573
- Testing
- Tigecycline, Clindamycin (or Vancomycin if needed)
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
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
Respiratory Tract Infections (RTI), Influenza-like Illness
Clinical Assessment of Respiratory Events for Kids: Integrating Diagnostics and Stewardship
This study, called Care4Kids, aims to improve the management of respiratory infections in children visiting emergency departments.
- Conditions
- Respiratory Tract Infections (RTI), Influenza-like Illness, Children
- Trial name
- CARE4KIDS (NCT07453914)
- Testing
- SPOTFIRE R
- Where
- 3 sites in France, Greece and 1 more
- Volunteers
- 720 people
- Sponsor
- BioMérieux
Pneumococcal Vaccines
Safety, Tolerability, and Immunogenicity of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Healthy Infants
The objective of the study is to evaluate the safety and tolerability of 4 injections of VAX-24 (at 3 dose levels) compared to PCV15 in infants at 2, 4, 6, and 12-15 months of age, in addition to receiving routine US concomitant…
- Trial name
- NCT05844423
- Testing
- 0.5 ml dose of 1.1 mcg VAX-24, 0.5 ml dose of PCV20, 0.5 ml dose of 2.2 mcg VAX-24
- Where
- 32 sites in United States
- Volunteers
- 802 people, healthy volunteers welcome
- Sponsor
- Vaxcyte, Inc.
Onchocerciasis
Pediatric Pharmacokinetics And Safety Study Of Moxidectin
The purpose of this study is to measure the amount of moxidectin in subjects' blood and to measure safety. This study will enroll 36 children aged 4 to 11 years (>=12 kg) with or without Onchocerca volvulus (O volvulus)…
- Trial name
- NCT01035619
- Testing
- moxidectin
- Volunteers
- healthy volunteers welcome
- Sponsor
- Pfizer
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
Diphtheria, Tetanus
Antibody Persistence at Age 3.5 and 4.5 Years After Primary and Booster DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccination
This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722) and booster vaccination in Study A3L27 (NCT01444781).
- Conditions
- Diphtheria, Tetanus, Whooping Cough, Hepatitis B
- Trial name
- NCT01983540
- Testing
- DTaP-IPV-Hep B- PRP~T + Prevenar + Rotarix vaccine, DTaP- IPV-Hep B-PRP~T + Prevenar + Rotarix + Infanrix hexa vaccine, Infanrix hexa + Prevenar + Rotarix vaccine
- Where
- 2 sites in Colombia, Costa Rica
- Volunteers
- 558 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company