Clinical trials: Pediatric Infectious Disorder
Japanese Encephalitis
Open-label, Randomized Study in a Pediatric Population in a JEV (Japanese Encephalitis Virus)-Endemic Country
This is a randomized, open-label Phase 3 study including children aged >9 months to <17 years and 7 months who have been vaccinated with IXIARO in study IC51-323.
- Trial name
- NCT01296360
- Testing
- IXIARO
- Where
- 3 sites in Philippines
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Valneva Austria GmbH
Invasive Pulmonary Aspergillosis, Lymphoblastic Leukaemia
Nebulized Amphotericin B Lipid Complex in Invasive Pulmonary Aspergillosis in Paediatric Patients With Acute Leukaemia
The trial evaluates the overall tolerability of the drug and the efficacy of aerosolised amphotericin B as a lipid complex (ABLC) for primary prophylaxis of invasive pulmonary aspergillosis (IPA) in pediatric patients with acute…
- Conditions
- Invasive Pulmonary Aspergillosis, Lymphoblastic Leukaemia, Myeloblastic Leukaemia, Lymphoblastic Leukemia
- Trial name
- NCT01615809
- Testing
- AMPHOTERICIN B
- Where
- Spain
- Volunteers
- 32 people
- Sponsor
- Fundació Sant Joan de Déu
Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE)
COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders
This is a randomized, multi-site, adaptive, open-label clinical trial comparing the immune response to different additional doses of COVID-19 vaccine in participants with autoimmune disease requiring IS medications.
- Conditions
- Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Pemphigus Vulgaris, Multiple Sclerosis (MS)
- Trial name
- NCT05000216
- Testing
- Moderna mRNA-1273, BNT162b2, Ad26.COV2.S
- Where
- 29 sites in United States
- Volunteers
- 258 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
Pediculosis
Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice
In this study, Malathion Gel 0.5% will be compared to Nix (permethrin 1%) as a treatment for head lice in patients 2 years of age and older. Malathion Gel 0.5% is a new formulation of an established head lice treatment.
- Trial name
- NCT00927472
- Testing
- Malathion gel 0.5%, Permethrin 1% rinse
- Where
- 2 sites in United States
- Volunteers
- 254 people
- Sponsor
- Sun Pharmaceutical Industries, Inc.
HIV Infections
A Food-effect Study of the Pediatric Dispersible Tablet Formulations of TRIUMEQ® and DOVATO® in Healthy Adult Participants
This study will assess the effect of food on the pharmacokinetics (PK) of pediatric formulations of TRIUMEQ (dolutegravir [DTG] 5 milligrams [mg]/abacavir [ABC] 60 mg/lamivudine [3TC] 30 mg) dispersible tablets and DOVATO (DTG 5…
- Trial name
- NCT04827134
- Testing
- TRIUMEQ, DOVATO
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Measles, Mumps
Frozen ProQuad Administered Concomitantly Versus Nonconcomitantly With Other Pediatric Vaccines
This study will assess the safety and immunogenicity of ProQuad when administered concomitantly and nonconcomitantly with Tripedia and Comvax.
- Conditions
- Measles, Mumps, Rubella, Varicella
- Trial name
- NCT00984295
- Testing
- Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, Comparator: Tripedia, Comparator: Comvax
- Volunteers
- 1,913 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme 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)
Ear Infection, Pediatric Disease
Evaluation of Cellphone Based Otoscopy in Pediatric Patients
The Cellscope is an iPhone-based otoscope that uses the iPhone camera and light source to capture HIPAA compliant images and video recordings of the external and middle ear structure.
- Conditions
- Ear Infection, Pediatric Disease, Acute Otitis Media
- Trial name
- NCT04296448
- Testing
- Cellscope
- Where
- United States
- Volunteers
- 197 people
- Sponsor
- Johns Hopkins University
Tinea Pedis, Tinea Cruris
Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis
This study is being done to see how the body is affected when a study drug is applied to both feet if the subject has athlete's foot or to both feet and the groin area if the subject has both athlete's foot and jock itch.
- Trial name
- NCT01712360
- Testing
- NAFT500 (pediatric), NAFT600 (pediatric), NAFT500 (adult)
- Where
- 4 sites in United States, Dominican Republic and 1 more
- Volunteers
- 56 people
- Sponsor
- Merz North America, Inc.
Hepatitis B, Chronic
A Study of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus (HBV)-Infection
The purpose of this clinical study is to determine the appropriate doses of entecavir to use in children and adolescents. Safety, tolerability and efficacy will also be studied
- Trial name
- NCT00423891
- Testing
- Entecavir
- Where
- 19 sites in United States, Argentina and 6 more
- Volunteers
- 64 people
- Sponsor
- Bristol-Myers Squibb
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
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
HIV Infections
PRINCE: Study of Atazanavir (ATV)/Ritonavir (RTV)
The purpose of this study is to determine whether atazanavir powder combined with ritonavir is safe and well tolerated and produces appropriate drug exposure in children ≥3 months to <6 years of age.
- Trial name
- PRINCE1 (NCT01099579)
- Testing
- Atazanavir powder, Ritonavir oral solution, Atazanavir capsules
- Where
- 18 sites in Brazil, Chile and 4 more
- Volunteers
- 82 people
- Sponsor
- Bristol-Myers Squibb
Methicillin-Resistant Staphylococcus Aureus, Bacterial Infections
Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Children, Known or Suspected to be Caused by Susceptible Gram-positive Organisms, Including MRSA
To determine the safety and descriptive efficacy of dalbavancin for the treatment of acute bacterial skin and skin structure infections in children, aged birth to 17 years (inclusive), known or suspected to be caused by…
- Conditions
- Methicillin-Resistant Staphylococcus Aureus, Bacterial Infections, Staphylococcal Skin Infections
- Trial name
- NCT02814916
- Testing
- Dalbavancin, Vancomycin, Oxacillin
- Where
- 84 sites in United States, Argentina and 18 more
- Volunteers
- 199 people
- Sponsor
- AbbVie
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
Leukemia, Lymphoma
Preemptive Ethanol Lock Therapy in Pediatric Bloodstream Infection
The study team will compare hospital length of stay (LOS) and attributable length of stay (ALOS, the LOS attributable to CRI), in a randomized, un-blinded prospective trial utilizing short-dwell ethanol-lock therapy (ELT) (4…
- Conditions
- Leukemia, Lymphoma, Blood Disorders, Solid Tumors
- Trial name
- NCT02095951
- Testing
- Ethanol lock therapy (ELT)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Children's Hospital of Michigan
HCV Infection
Elbasvir (EBR)/Grazoprevir (GZR) in Pediatric Participants With Chronic Hepatitis C Infection (MK-5172-079)
The purpose of this study is to assess the pharmacokinetics (PK), safety, and efficacy of oral MK-5172 (a fixed dose combination [FDC] tablet containing elbasvir [EBR] 50 mg and grazoprevir [GZR] 100 mg) and EBR/GZR (varying…
- Trial name
- NCT03379506
- Testing
- EBR/GZR FDC Tablet, Grazoprevir Oral Granules, Elbasvir Oral Granules
- Where
- 15 sites in United States, Germany and 2 more
- Volunteers
- 57 people
- Sponsor
- Merck Sharp & Dohme LLC
RESPIRATORY SYNCYTIAL VIRUS (RSV)
A Study to Learn About the Safety and Immune Activity of RSVpreF in Children 2 to <18 Years of Age
The purpose of this study is to learn about the safety and immune activity of the vaccine (called RSVpreF) in children 2 to <18 years of age.
- Trial name
- PICASSO (NCT05900154)
- Testing
- RSVpreF 120 µg, RSVpreF 60 µg
- Where
- 17 sites in United States
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- Pfizer
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