Clinical trials: Pediatric Infectious Disease
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.
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
HIV Infections
An Open-Label Study of Emtricitabine in Combination With Other Antiretroviral Agents in HIV Infected Pediatric Subjects
To obtain safety and efficacy data for antiretroviral regimens containing emtricitabine in HIV-1 infected pediatric subjects. To determine emtricitabine concentrations in HIV-1 infected pediatric subjects and, if necessary, to…
- Trial name
- NCT00642291
- Testing
- Emtricitabine
- Where
- 2 sites in Romania
- Volunteers
- 16 people
- Sponsor
- Gilead Sciences
HIV Infections
The Safety and Effectiveness of Zidovudine Plus Lamivudine, Used With and Without 1592U89, in HIV-1 Infected Children Who Have Taken Anti-HIV-1 Drugs
To compare the safety, tolerance, durability of the viral load response and the antiviral activity of the 1592U89/zidovudine(ZDV)/lamivudine (3TC) regimen vs. ZDV/3TC regimen.
- Trial name
- NCT00002391
- Testing
- Abacavir sulfate, Lamivudine, Zidovudine
- Where
- 30 sites in United States
- Sponsor
- Glaxo Wellcome
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
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
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.
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
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
Tinea Capitis
Terbinafine Compared to Griseofulvin in Children With Tinea Capitis
Tinea capitis is a dermatophyte infection of the scalp hair follicles, which occurs primarily in children. Hair loss, hair breakage, scaling, plus various degrees of erythema, pustules and pruritus are the primary clinical signs…
- Trial name
- NCT00117754
- Testing
- Terbinafine hydrochloride
- Where
- United States
- Volunteers
- 720 people
- Sponsor
- Novartis
Herpes Simplex
Valaciclovir Hydrochloride Phase III for Hematopoietic Stem Cell Transplantation Patients
The purpose of this study is to evaluate the preventive efficacy for HSV infection and safety of valaciclovir (VACV) in the adult and pediatric HSCT patients.
- Trial name
- NCT01602562
- Testing
- VACV tablets (Adults or pediatrics) or granules (pediatrics)
- Where
- 11 sites in Japan
- Volunteers
- 40 people
- Sponsor
- GlaxoSmithKline
Nosocomial Infections
Efficacy of Copper in Reducing Health-Acquired Infections in a Pediatric Intensive Care Unit
Healthcare-acquired infections (HAI) cause substantial patient morbidity and mortality. Commonly touched items in the patient care environment harbor microorganisms that may contribute to HAI risk.
- Trial name
- NCT01678612
- Testing
- Copper-alloy surfaced objects
- Where
- Chile
- Volunteers
- 1,012 people
- Sponsor
- Codelco
Pneumococcal Vaccines
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Infants
The objective of the study is to evaluate the safety, tolerability, and immunogenicity of 4 injections of VAX-31 (at 4 dose levels) compared to PCV20 in infants at 2, 4, 6, and 12-15 months of age, in addition to receiving…
- Trial name
- NCT06720038
- Testing
- 0.5 mL of the low dose VAX-31, 0.5 mL of the mid dose VAX-31, 0.5 mL of the high dose VAX-31
- Where
- 48 sites in United States, Puerto Rico
- Volunteers
- 900 people, healthy volunteers welcome
- Sponsor
- Vaxcyte, Inc.
HIV/AIDS
REMUNE HIV/AIDS Vaccine Phase II Pediatric Safety & Efficacy Clinical Study
The primary objective is to compare \& evaluate between the treatment groups the changes in decline/reduction of HIV viral load \& increase changes in WBC white blood cell counts in the adult Remune dose vs the low dose Remune…
- Trial name
- NCT02291809
- Testing
- REMUNE
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Immune Response BioPharma, Inc.
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
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
Infections, Human Immunodeficiency Virus and Herpesviridae
Relative Bioavailability Study of a Pediatric Granule Formulation of Dolutegravir
Dolutegravir (DTG, GSK1349572) is an integrase inhibitor currently in Phase 3 clinical trials for the treatment of human immunodeficiency virus (HIV) infection.
- Trial name
- NCT01382238
- Testing
- Dolutegravir 50 mg tablet, Dolutegravir 50 mg oral granules
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
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
Onychomycosis
Clinical Trial on Onychomycosis With P-3058 Nail Solution in Pediatric Population
Pediatric patients affected by mild-to-moderate distal subungual onychomycosis (DSO) or affected by white superficial onychomycosis (WSO), due to dermatophytes, will be treated topically with P-3058 nail solution according to the…
- Trial name
- NCT02547701
- Testing
- P-3058
- Where
- 5 sites in Belgium, Germany and 3 more
- Volunteers
- 20 people
- Sponsor
- Polichem S.A.
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.