Clinical trials: Pediatric Infectious Disorder
- Condition Pediatric Infectious Disorder
- Funder type Industry (pharma, biotech, devices)
- Has posted results yes
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
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
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.
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
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
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
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
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
- NCT00963508
- Testing
- Malathion gel 0.5%, Permethrin 1% rinse (Nix Crème)
- Where
- 7 sites in United States
- Volunteers
- 403 people
- Sponsor
- Sun Pharmaceutical Industries, Inc.
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
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
Nosocomial Pneumonia
Safety and Pharmacokinetics of Ceftolozane/Tazobactam in Pediatric Participants With Nosocomial Pneumonia (MK-7625A-036)
This is a phase 1, open-label, non-comparative, multicenter clinical study to evaluate the safety, tolerability, and pharmacokinetics of ceftolozane/tazobactam (MK-7625A) in pediatric participants with nosocomial pneumonia (NP).
- Trial name
- NCT04223752
- Testing
- Ceftolozane/Tazobactam
- Where
- 24 sites in United States, Chile and 7 more
- Volunteers
- 41 people
- Sponsor
- Merck Sharp & Dohme LLC
Skin Infections, Bacterial
Pharmacokinetics of Retapamulin in Pediatric Subjects With Uncomplicated Skin Infections.
A study to evaluate the pharmacokinetics of Retapamulin Ointment, 1%, in pediatric subjects (2-24 months) with secondarily-infected traumatic lesions, secondarily-infected dermatoses, or impetigo (bullous and non-bullous).
- Trial name
- NCT00555061
- Testing
- Retapamulin Ointment, 1%
- Where
- 25 sites in United States, Argentina and 7 more
- Volunteers
- 60 people
- Sponsor
- GlaxoSmithKline
Cytomegalovirus (CMV) Infection
Letermovir Treatment in Pediatric Participants Following Allogeneic Haematopoietic Stem Cell Transplantation (HSCT) (MK-8228-030)
The primary objective of this study is to evaluate the pharmacokinetics (PK) of letermovir (LET) in pediatric participants. Participants will be enrolled in the following 3 age groups: Age Group 1: From 12 to <18 years of age…
- Trial name
- NCT03940586
- Testing
- Letermovir oral granules, Letermovir tablet, Letermovir intravenous
- Where
- 40 sites in United States, Australia and 9 more
- Volunteers
- 65 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C, Chronic
5 Year Long-term Follow up in Pediatric Participants Who Received PegIntron Plus Rebetol in P02538 Part I (P02538 Pt 2)
Study P02538 Part 2 is a 5-year long term follow-up (LTFU) study in pediatric participants who were treated with at least one dose of peginterferon alfa-2b (PEG-IFN) and ribavirin (RBV) and who completed the follow-up in the…
- Trial name
- NCT00761735
- Testing
- Peginterferon alfa-2b, Ribavirin
- Volunteers
- 94 people
- Sponsor
- Merck Sharp & Dohme LLC
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.