Clinical trials: Pediatric Infectious Disorder
Cough, Upper Respiratory Tract Infection
Comparison of Efficacy and Tolerability of Two Cough Syrups in Cough Due to Cold in Children.
The purpose of this study is to determine if there is comparable efficacy between carbocisteine and a protective cough syrup from natural ingredients in children's cough due to upper respiratory tract infections (URTI) such as…
- Trial name
- URTI (NCT01968434)
- Testing
- protective cough syrup, carbocisteine cough syrup
- Where
- 4 sites in Israel
- Volunteers
- 150 people
- Sponsor
- Clalit Health Services
Pseudomonas Aeruginosa Respiratory Tract Infection/Colonization, Cystic Fibrosis
Study of Aztreonam for Inhalation in Children With Cystic Fibrosis and New Infection of the Airways by Pseudomonas Aeruginosa Bacteria
The primary objective of this study is to evaluate the safety and efficacy of a 14-day course versus a 28-day course of aztreonam for inhalation solution (AZLI) in pediatric participants with new onset Pseudomonas aeruginosa…
- Trial name
- ALPINE 2 (NCT03219164)
- Testing
- AZLI
- Where
- 53 sites in United States, Austria and 10 more
- Volunteers
- 149 people
- Sponsor
- Gilead Sciences
Hunter Syndrome
An Extension Study of HGT-HIT-045 Evaluating Long-Term Safety and Clinical Outcomes of Idursulfase-IT in Conjunction With Elaprase in Pediatric Participants With Hunter Syndrome and Cognitive Impairment
This extension study of HGT-HIT-045 is designed to collect long-term safety data in pediatric participants with Hunter syndrome and cognitive impairment who are receiving intrathecal (IT) idursulfase-IT and intravenous (IV)…
- Trial name
- NCT01506141
- Testing
- Idursulfase-IT, Elaprase
- Where
- 9 sites in United States, Canada and 1 more
- Volunteers
- 15 people
- Sponsor
- Takeda
HIV Infections
Safety and Pharmacokinetics (PK) of Raltegravir in HIV (Human Immunodeficiency Virus)-Infected Children and Adolescents
Integrase is 1 of 3 HIV (Human Immunodeficiency Virus)-1 enzymes required for viral replication. Raltegravir is a drug that prevents integrase from working properly.
- Trial name
- NCT00485264
- Testing
- Raltegravir poloxamer film coated tablet, Raltegravir chewable tablet, Raltegravir oral granules for suspension (20 mg/mL)
- Where
- 42 sites in United States, Argentina and 4 more
- Volunteers
- 153 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
To Assess the Relative Bioavailability (BA) of TRIUMEQ® and Dolutegravir and Lamivudine (DTG/3TC) Pediatric Dispersible Tablet Formulations in Healthy Volunteers
This is a 2-part, single-dose, open label, randomized 3-way cross-over study to compare BA of pediatric study drugs TRIUMEQ and (DTG/3TC) in healthy volunteers under fasted conditions. Study will be conducted in 2-parts.
- Trial name
- NCT03441984
- Testing
- Treatment A, Treatment B, Treatment C
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Infection Prevention
Study of Catheter-related Infections Using Antibiotic-coated Versus Conventional Catheters in Children
The primary purpose of the study is to determine if a therapeutic difference exists between central venous catheters impregnated with minocycline and rifampin and conventional catheters not impregnated with antibiotics when used…
- Trial name
- NCT00370149
- Testing
- Antibiotic-impregnated Catheters (M/R), Non-impregnated Catheters (C/S)
- Where
- United States
- Volunteers
- 326 people
- Sponsor
- Indiana University
HIV/AIDS Treatment, HIV Infections
Lopinavir/Ritonavir (Kaletra) PK in Children
The objective of this study is to compare the pharmacokinetics of lopinavir tablets administered to pediatric patients as either whole or crushed tablets.
- Trial name
- NCT00810108
- Testing
- lopinavir/ritonavir (Kaletra®) tablets
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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.
Pediatric HIV, HIV Infections
Equivalence of Boosted Atazanavir Based Regimens and Currently Effective HAART Regimens
The hypothesis for this study is whether a treatment regimen containing Atazanavir in combination with Ritonavir will work as well as other regimens containing a protease inhibitor and/or a Non-nucleoside Reverse Transcriptase…
- Trial name
- NCT00940771
- Testing
- Boosted Atazanavir
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Phoenix Children's Hospital
Covid19, Corona Virus Infection
A Study of Baricitinib (LY3009104) in Children With COVID-19
The purpose for this study is to determine if the study drug baricitinib is effective and safe in hospitalized pediatric participants with Coronavirus disease 2019 (COVID -19) and to confirm the dose.
- Trial name
- COV-BARRIER (NCT05074420)
- Testing
- Baricitinib
- Where
- 14 sites in United States, Brazil and 2 more
- Volunteers
- 6 people
- Sponsor
- Eli Lilly and Company
Hepatitis C, Chronic
Study of PEG-Intron Plus REBETOL in Pediatric Subjects With Chronic Hepatitis C (Study P02538 Part 1)
The primary objective is to assess the safety, efficacy and tolerability of the combination of PEG-Intron plus REBETOL in pediatric subjects with chronic hepatitis C.
- Trial name
- NCT00104052
- Testing
- peginterferon alfa-2b (PEG2b) (SCH 54031), ribavirin (SCH 18908)
- Volunteers
- 107 people
- Sponsor
- Merck Sharp & Dohme LLC
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
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
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
Trichuris Infection, Helminthiasis
Albendazole Plus High Dose Ivermectin for Trichuriasis in Pediatric Patients
There are four species of intestinal worms collectively known as soil-transmitted helminthiasis (STH): Ancylostoma duodenale and Necator americanus (hookworms), Ascaris lumbricoides (roundworms), and Trichuris trichiura…
- Trial name
- HI4T (NCT04041453)
- Testing
- Ivermectin, Albendazole
- Where
- 2 sites in Argentina, Honduras
- Volunteers
- 176 people
- Sponsor
- Alejandro Krolewiecki
Herpes Simplex
Pharmacokinetics, Acceptability and Safety of Famciclovir in Infants (1 Month to Less Than 12 Months) With Herpes Simplex Infection
This study will evaluate the acceptability and safety of famciclovir in infants with herpes simplex infection
- Trial name
- NCT00448227
- Testing
- famciclovir
- Where
- 6 sites in United States
- Volunteers
- 18 people
- Sponsor
- Novartis
Infection, Human Immunodeficiency Virus I
48-Week Study Of GW433908 And Ritonavir Or GW433908 Alone, Twice Daily In Pediatric Patients With HIV Infection
This is a 48-week study to collect information on the safety and activity of an investigational medicine in patients, ages 2 to 18 years old, with HIV infection .
- Trial name
- NCT00089583
- Testing
- LEXIVA (GW433908), Ritonavir
- Where
- 39 sites in United States, Belgium and 5 more
- Volunteers
- 110 people
- Sponsor
- ViiV Healthcare
Short Bowel Syndrome
rtPA in in the Prevention of CVAD-Associated Thrombosis and Infection in Pediatric Patients With Short Bowel Syndrome
The primary research question is, in patients with short bowel syndrome requiring central venous access device (CVAD) for long-term total parenteral nutrition, is once weekly recombinant tissue plasminogen activator (rtPA) lock…
- Trial name
- NCT02355743
- Testing
- rtPA lock therapy
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Lynn Malec
Measles, Varicella
Immunogenicity & Safety Study of GSK Biologicals' 208136 Vaccine Formulated With New Measles and Rubella Working Seeds
This study is undertaken to generate clinical data on GSK Biologicals' combined measles-mumps-rubella-varicella vaccine manufactured with measles and rubella obtained from newly established working seed viruses which are one…
- Conditions
- Measles, Varicella, Mumps, Rubella
- Trial name
- NCT00892775
- Testing
- Priorix-Tetra (combined measles-mumps-rubella-varicella vaccine), GSK Biologicals' 208136, new formulation
- Where
- 6 sites in Singapore, Taiwan
- Volunteers
- 501 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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