Clinical trials: Pediatric Infectious Disorder
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 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
Pediatric Gastroenteritis
Gastroenteritis From Rotavirus Infection in Brazilian Children Less Than 5 Years of Age (Study V260-031).
This is a 1-year study evaluating hospitalizations and the medical care for the treatment of diarrhea from rotavirus infection in children < 5 years of age, conducted in four hospitals located in four Brazilian regions.
- Trial name
- NCT01195844
- Testing
- Rotavirus Vaccine
- Volunteers
- 230 people
- Sponsor
- Merck Sharp & Dohme LLC
Chickenpox, Herpes Zoster
Famciclovir Oral Pediatric Formulation in Children 1-12 Years of Age With Varicella Zoster Infection
Varicella zoster virus causes chickenpox in children and shingles in adults. Chickenpox is usually a self-limiting illness characterized by fever and a rash.
- Trial name
- NCT00098046
- Testing
- famciclovir
- Where
- 5 sites in United States, Costa Rica and 2 more
- Volunteers
- 76 people
- Sponsor
- Novartis
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
Pharyngitis
Pharyngitis,Group A Streptococcal Infection,Rapid Streptococcal Test,Throat Swab Culture
Comparison of Immunochromatographic Test for rapid detection of group A streptococcal antigen with culture in Pediatric patients.
- Trial name
- NCT02494219
- Testing
- Rapid Immunochromatographic streptococcal test
- Where
- Qatar
- Volunteers
- 906 people
- Sponsor
- Hamad Medical Corporation
Ear Infection
Application of the Belle.AI Comparative Image Reference System for Describing Chronic Ear Infections in Pediatric Patients From Low-Resource Communities
The purpose of this research is to examine the clinical effectiveness of an investigational AI-powered smartphone app that describes the physical characteristics of an otoscopy image. It is not intended to make any diagnosis.
- Trial name
- Otoscopy AI (NCT07025473)
- Testing
- Smartphone-enabled otoscopy
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- BelleTorus Corporation
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
Chronic Hepatitis C Infection
A Study to Evaluate Treatment of Hepatitis C Virus Infection in Pediatric Subjects
This was a Phase 2/3, open-label, multicenter study to evaluate the pharmacokinetics (PK), efficacy, and safety of ombitasvir/paritaprevir/ritonavir (OBV/PTV/RTV) with or without dasabuvir (DSV) and with or without ribavirin…
- Trial name
- ZIRCON (NCT02486406)
- Testing
- Ombitasvir/paritaprevir/ritonavir, Dasabuvir, Ribavirin
- Where
- 21 sites in United States, Belgium and 3 more
- Volunteers
- 64 people
- Sponsor
- AbbVie
Severe Respiratory Syncytial Virus Infection
Retrospective Palivizumab Study in Children With Hemodynamically Significant Congenital Heart Disease
Retrospective medical record review study of specific adverse events in children with congenital heart disease who received palivizumab for prophylaxis of serious respiratory syncytial virus infection and control subjects that…
- Trial name
- NCT01075178
- Where
- 37 sites in Austria, Belgium and 8 more
- Volunteers
- 2,036 people
- Sponsor
- Abbott
Hepatitis C Virus (HCV)
Efficacy Study Of Oral Glecaprevir/Pibrentasvir Tablet In Pediatric (12 Years and Older) And Adult Treatment-Naive Participants With Chronic Hepatitis C Genotypes 1 To 6 And Liver Cirrhosis
Hepatitis C Virus (HCV) infection is among the most common of all chronic liver diseases. HCV predominantly affects liver cells and causes the liver to become inflamed and damaged.
- Trial name
- EASY (NCT04352309)
- Where
- 6 sites in Russia
- Volunteers
- 99 people
- Sponsor
- AbbVie
HIV Infections
Clinical Sensitivity of Clearview Rapid Tests in 12-17 y/o Pediatric Population
This study is to establish the clinical sensitivity of the Chembio Diagnostics Systems, Inc. Clearview COMPLETE HIV 1/2 Assay and Clearview HIV 1/2 Stat-Pak Assay (Clearview HIV tests) in pediatric subjects who are between 12 and…
- Trial name
- NCT00567749
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Chembio Diagnostic Systems, Inc.
Bacteremia, Soft Tissue Infections
Safety, Efficacy, and Pharmacokinetics (PK) of Daptomycin (MK-3009) in Japanese Pediatric Subjects With Complicated Skin and Soft Tissue Infections (cSSTI) and Bacteremia (MK-3009-029)
The purpose of this study is to assess the safety, efficacy and pharmacokinetic (PK) parameters of daptomycin for injection in Japanese pediatric participants aged 1 to 17 years with complicated skin and soft tissue infection…
- Conditions
- Bacteremia, Soft Tissue Infections, Skin Diseases, Infectious
- Trial name
- NCT03643952
- Testing
- Daptomycin for Injection
- Where
- 16 sites in Japan
- Volunteers
- 18 people
- Sponsor
- Merck Sharp & Dohme LLC
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
Pediculosis
Pharmacokinetic (PK) and Tolerance Study of Natroba Topical Suspension in Pediatrics With an Active Head Lice Infestation
A pharmacokinetic and tolerance study of Natroba (spinosad) Topical Suspension, 0.9% in pediatric subjects 6 months to 4 years of age with an active head lice infestation.
- Trial name
- NCT01660321
- Testing
- spinosad
- Where
- 2 sites in United States
- Volunteers
- 26 people
- Sponsor
- ParaPRO LLC
Respiratory Syncytial Virus Infection
Surveillance of Synagis in Korean Pediatric Patients
Approximately 600 pediatric patients prescribed palivizumab (Synagis) prophylaxis in usual practice according to the approved Korean product label will be registered into this observational study.
- Trial name
- NCT01537198
- Volunteers
- 618 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Otitis Media
Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes
This is an 8-week, multicenter, open-label study in which eligible subjects with a history of otitis media requiring TT placement will receive 6 mg OTO-201 to each ear.
- Trial name
- NCT02600559
- Testing
- OTO-201 (ciprofloxacin)
- Where
- United States
- Volunteers
- 501 people
- Sponsor
- Otonomy, Inc.
Healthy Volunteers (Meningococcal Infection)
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US
The purpose of this study was to compare the immunogenicity and describe the safety of MenACYW conjugate vaccine and MENVEO® when both are administered concomitantly with routine pediatric vaccines to healthy infants and toddlers…
- Trial name
- NCT03537508
- Testing
- MenACYW conjugate vaccine, MenACYW-135 conjugate vaccine, DTaP-IPV//Hib vaccine
- Where
- 70 sites in United States, Puerto Rico
- Volunteers
- 2,627 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Hunter Syndrome
A Safety and Dose Ranging Study of Idursulfase (Intrathecal) Administration Via an Intrathecal Drug Delivery Device in Pediatric Patients With Hunter Syndrome Who Have Central Nervous System Involvement and Are Receiving Treatment With Elaprase®
Elaprase (idursulfase), a large molecular protein, is not expected to cross the blood brain barrier at therapeutic levels when administered intravenously.
- Trial name
- NCT00920647
- Testing
- Control, Idursulfase IT (1 mg), Idursulfase IT (10 mg)
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 16 people
- Sponsor
- Shire
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