Clinical trials: Neonatal Infections
Gram-Negative Bacterial Infections
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants
The primary purpose of this study is to understand the pharmacokinetics (PK) of single and multiple doses of cefiderocol in children from birth to less than 3 months of age with suspected or confirmed aerobic Gram-negative…
- Trial name
- NCT06086626
- Testing
- Cefiderocol, Standard of Care
- Where
- 4 sites in United States, South Africa and 1 more
- Volunteers
- 30 people
- Sponsor
- Shionogi
Cytomegalovirus Retinitis, HIV Infections
A Phase I/II Trial to Assess the Safety and Tolerance of Escalating Doses of a Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Retinitis
To determine the safety and tolerance of 3 dosage levels of human anti-cytomegalovirus (CMV) monoclonal antibody (SDZ MSL-109) when administered once every 2 weeks for a total of 8 doses during the maintenance phase of…
- Trial name
- NCT00002016
- Testing
- Sevirumab
- Where
- 2 sites in United States
- Sponsor
- Sandoz
Neurogenic Detrusor Overactivity
Open-label, Long-term Safety, Efficacy, and Pharmacokinetics Study of Vibegron in Pediatric Subjects 2 Years to < 18 Years of Age With NDO and on CIC
The purpose of this study is to evaluate the safety, efficacy, and PK of Vibegron in pediatric participants with NDO who are regularly using CIC
- Trial name
- KANGUROO (NCT05491525)
- Testing
- Vibegron
- Where
- 38 sites in United States, Belgium and 14 more
- Volunteers
- 71 people
- Sponsor
- Urovant Sciences GmbH
Chronic Pseudomonas Aeruginosa Infection, Cystic Fibrosis (CF)
Study With Phage for CF Subjects With Pseudomonas Lung Infection
The goal of this Phase 2b clinical trial is to see if nebulized phage (BX004) can treat chronic Pseudomonas aeruginosa (PsA) lung infection in CF subjects.
- Trial name
- NCT06998043
- Testing
- BX004
- Where
- 14 sites in United States
- Volunteers
- 63 people
- Sponsor
- BiomX Ltd
Gram Negative Infections
A Study to Assess How Vaborem® is Taking up in the Body and Tolerated in Paediatric Patients With Gram Negative Infections, Including But Not Restricted to Complicated Urinary Tract Infections
The goal of this clinical trial is to assess the pharmacokinetic (PK) and safety and tolerability of Vaborem (fixed combination of meropenem and vaborbactam) in the paediatric population aged from birth to < 18 years with…
- Trial name
- NCT06828848
- Testing
- Meropenem plus vaborbactam
- Where
- 22 sites in Czechia, France and 3 more
- Volunteers
- 44 people
- Sponsor
- Menarini Group
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
HIV-1-infection
Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV
The goal of this clinical study is to learn more about the study drug, Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), safety, tolerability, and pharmacokinetics (how B/F/TAF is absorbed, modified, distributed, and…
- Trial name
- NCT07055451
- Testing
- B/F/TAF
- Where
- 7 sites in United States, South Africa
- Volunteers
- 16 people
- Sponsor
- Gilead Sciences
Hepatitis B
Long Term Follow-Up Study 16-20 Years After Hepatitis B Vaccination in Newborns of Mothers Who Were Seropositive for Hepatitis B Envelope Antigen (HBeAg) & Hepatitis B Surface Antigen (HBsAg)
This study is performed to evaluate the persistence of anti-hepatitis B surface antigen (HBs) antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine, Engerix-B™.
- Trial name
- NCT00240539
- Testing
- Blood sampling
- Where
- Thailand
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Atopic Dermatitis, Alopecia Areata
A Longitudinal Observational Study of Patients Undergoing Therapy for IMISC
TARGET-DERM is a longitudinal, observational study of adult and pediatric patients being managed for Atopic Dermatitis and other Immune-Mediated Inflammatory Skin Conditions (IMISC) in usual clinical practice.
- Conditions
- Atopic Dermatitis, Alopecia Areata, Hidradenitis Suppurativa, Vitiligo
- Trial name
- TARGET-DERM (NCT03661866)
- Where
- 62 sites in United States, Canada and 2 more
- Volunteers
- 15,000 people
- Sponsor
- Target PharmaSolutions, Inc.
Candidiasis, Chronic Mucocutaneous
CAMB/MAT2203 in Patients With Mucocutaneous Candidiasis
This is an open-label, dose-titration trial to study the efficacy, safety, and pharmacokinetics of oral cochleate amphotericin B (CAMB) in the treatment of mucocutaneous candidiasis infections in patients who are refractory or…
- Trial name
- CAMB (NCT02629419)
- Testing
- Amphotericin B
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Matinas BioPharma Nanotechnologies, Inc.
Bronchopulmonary Dysplasia
Safety and Efficacy of MSC-EVs in the Prevention of BPD in Extremely Preterm Infants
The phase 1/2 trial aims to evaluate the safety and efficacy of EXOB-001 consisting of extracellular vesicles derived from umbilical cord mesenchymal stromal cells in the prevention of bronchopulmonary dysplasia (BPD) in…
- Trial name
- EVENEW (NCT06279741)
- Testing
- Endotracheopulmonary Instillation, Suspension
- Where
- 8 sites in Belgium, Italy
- Volunteers
- 265 people
- Sponsor
- EXO Biologics S.A.
Onychomycosis of Toenails
Efficacy and Safety of AN2690 Topical Solution to Treat Onychomycosis of the Toenail
The purpose of this study is to determine whether AN2690 topical solution is a safe and effective treatment for onychomycosis of the toenail.
- Trial name
- NCT01302119
- Testing
- AN2690 Topical Solution, 5%, Solution Vehicle
- Where
- 32 sites in United States, Canada
- Volunteers
- 604 people
- Sponsor
- Pfizer
Candidiasis
Study to Compare the Efficacy and Safety of Micafungin Versus Conventional Amphotericin B for the Treatment of Neonatal Candidiasis
The study will evaluate how effective and how safe the drug micafungin is when compared to the drug amphotericin B deoxycholate in treating neonates and young infants with certain fungal infections.
- Trial name
- MAGIC-2 (NCT00815516)
- Testing
- micafungin, amphotericin B deoxycholate
- Where
- 17 sites in United States, Brazil and 10 more
- Volunteers
- 30 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Cystic Fibrosis, Burkholderia Infections
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis and Chronic Burkholderia Species Infection
The purpose of this research study was to determine if an experimental drug called Aztreonam for Inhalation Solution (AZLI) was safe and effective to treat Burkholderia lung infections in patients with cystic fibrosis (CF).
- Trial name
- NCT01059565
- Testing
- AZLI
- Where
- 35 sites in United States, Canada
- Volunteers
- 102 people
- Sponsor
- Gilead Sciences
Respiratory Syncytial Virus Infection
Clinical Study of Palivizumab in Japanese Newborns, Infants and Young Children at the Age of 24 Months or Less With Immunocompromised Medical Conditions
To evaluate safety, efficacy and pharmacokinetics of palivizumab in children at the age of 24 months or less with immunocompromised medical conditions.
- Trial name
- NCT01466062
- Testing
- Palivizumab
- Where
- 6 sites in Japan
- Volunteers
- 28 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Cytomegalovirus Infections, HIV Infections
A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine
To determine whether there is a pharmacokinetic drug interaction between oral ganciclovir and oral zidovudine (AZT) and between oral ganciclovir and oral didanosine (ddI).
- Trial name
- NCT00002096
- Testing
- Zidovudine, Didanosine, Ganciclovir
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- Hoffmann-La Roche
Sexually Transmitted Diseases
Prospective Registry of Exposure to Gepotidacin (PREG)
The purpose of this study is to monitor pregnancies exposed to gepotidacin and to evaluate possible teratogenic effects or birthweight-lowering effects of this medication relative to the primary outcomes of major congenital…
- Trial name
- NCT07850141
- Testing
- None (Observational study)
- Volunteers
- 614 people
- Sponsor
- GlaxoSmithKline
Influenza, Human, Pregnancy
Flucelvax (TIVc or QIVc) Pregnancy Registry
The study is a population based prospective cohort study designed to collect data on pregnancy outcomes and events of interest among women immunized with the TIVc or QIVc vaccine during pregnancy.
- Conditions
- Influenza, Human, Pregnancy, Birth Defect
- Trial name
- NCT03438487
- Testing
- Flucelvax Trivalent Influenza Vaccine, Flucelvax Quadrivalent Influenza Vaccine
- Where
- United States
- Volunteers
- 692 people, healthy volunteers welcome
- Sponsor
- Seqirus
Hunter Syndrome, Mucopolysaccharidosis II (MPS II)
Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Idursulfase
Study TKT024EXT was a long-term, single-arm, open-label extension of Study TKT024, a one year Phase 2/Phase 3 registration study.
- Trial name
- NCT00630747
- Testing
- Idursulfase
- Where
- 52 sites in United States, Brazil and 8 more
- Volunteers
- 94 people
- Sponsor
- Shire
Knee Osteoarthritis, Bone; Deformity, Congenital
COREV 2.0 PMCF-Study on Manual and Navigated Revision Knee Patients
The Columbus® Revision endoprosthetic system is bearing the CE-mark. This means that within the scope of this observational study the patient will not be subjected to any additional stressful, study-related medical examinations…
- Conditions
- Knee Osteoarthritis, Bone; Deformity, Congenital, Prosthesis Failure, Prosthesis-Related Infections
- Trial name
- COREV (NCT05113303)
- Testing
- Navigated Revision Total Knee Arthroplasty, Manual Revision Total Knee Arthroplasty
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Aesculap AG