Clinical trials: Newborn; Infection
Cystic Fibrosis
Phase 3 Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy Regimen for the Treatment of Chronic Pseudomonas Aeruginosa Infection in Patients With CF
The primary objective of this study is to evaluate the safety and efficacy of a CAT regimen with aztreonam for inhalation solution (AZLI) and tobramycin inhalation solution (TIS) in adult and pediatric subjects with cystic…
- Trial name
- AZLI CAT (NCT01641822)
- Testing
- AZLI, Tobramycin inhalation solution
- Where
- 71 sites in United States
- Volunteers
- 107 people
- Sponsor
- Gilead Sciences
Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less)
Clinical Evaluation of the "NICU Clinical Decision Support Dashboard" - CHMCO
This study evaluates the use of a NICU clinical integration system (Dashboard and accessories) in improving the quality of care delivered, patient health outcomes, and parent and clinician satisfaction.
- Conditions
- Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less), Neonatal Infection, Satisfaction
- Trial name
- NCT03673566
- Testing
- NICU Dashboard
- Where
- United States
- Sponsor
- Philips Healthcare
Pulmonary Infections, Pseudomonas Aeruginosa
Second Open Label Extension to Bridging Study CTBM100C2303
This was an open-label, single arm (uncontrolled) study in participants suffering from cystic fibrosis, who have completed their study participation in CTBM100C2303 and extension study one CTBM100C2303E1 (all visits), who were…
- Trial name
- NCT01069705
- Testing
- Tobramycin inhalation powder
- Where
- 17 sites in Bulgaria, Estonia and 5 more
- Volunteers
- 49 people
- Sponsor
- Novartis Pharmaceuticals
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
Atopic Dermatitis
A Phase II Study on Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in Subjects With Atopic Dermatitis
The purpose of this study is to compare the immunogenicity and safety of an investigational smallpox vaccine in subjects with atopic dermatitis to healthy volunteers.
- Trial name
- NCT00316602
- Testing
- IMVAMUNE
- Where
- 22 sites in United States, Mexico
- Volunteers
- 632 people, healthy volunteers welcome
- Sponsor
- Bavarian Nordic
Human Papillomavirus Infections
GARDASIL™ Vaccine Impact in Population Study (V501-033)
This study will assess the impact of GARDASIL™ human papillomavirus (HPV) vaccine in the general female population by utilizing nationwide registry databases in the participating Nordic countries.
- Trial name
- VIP (NCT01077856)
- Volunteers
- 54,516 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
PIK3CA-Related Overgrowth Spectrum (PROS)/Proteus Syndrome (PS)
A Study of the Safety and Tolerability in Participants With PIK3CA-related Overgrowth Spectrum or Proteus Syndrome Who Are Being Treated With Miransertib (MK-7075) in Other Studies (MK-7075-006)
This is a study of the safety and tolerability of oral miransertib (MK-7075) administered to participants at least 2 years of age with phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA)-related…
- Trial name
- NCT04980872
- Testing
- Miransertib
- Where
- 11 sites in United States, Australia and 3 more
- Volunteers
- 60 people
- Sponsor
- Merck Sharp & Dohme LLC
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
Cytomegalovirus Infections, Cytomegalovirus Retinitis
Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient
To make intravenous (IV) ganciclovir available to immunocompromised patients with life-threatening or sight-threatening Cytomegalovirus (CMV) infection, where the symptoms of the disease are too severe to allow admission to a…
- Conditions
- Cytomegalovirus Infections, Cytomegalovirus Retinitis, HIV Infections
- Trial name
- NCT00002025
- Testing
- Ganciclovir
- Where
- United States
- Sponsor
- Hoffmann-La Roche
Cytomegalovirus Retinitis, HIV Infections
A Phase I Study of the Safety of Proleukin (Aldesleukin) in Combination With Ganciclovir and Antiretroviral Therapy in HIV Seropositive Patients With Cytomegalovirus (CMV) Retinitis
To determine the MTD and dose-limiting toxicities of a regimen of therapeutic ganciclovir, antiretroviral therapy, and recombinant interleukin-2 (aldesleukin; Proleukin) as an immune adjuvant in HIV-seropositive patients.
- Trial name
- NCT00002321
- Testing
- Aldesleukin
- Where
- United States
- Sponsor
- Chiron Corporation
Cytomegalovirus Retinitis, HIV Infections
A Study of Valganciclovir in the Treatment of Cytomegalovirus (CMV) Retinitis in Patients With AIDS
The purpose of this study is to see if valganciclovir is a safe treatment for CMV retinitis in patients who have been treated for this condition in the past.
- Trial name
- NCT00002222
- Testing
- Valganciclovir
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Hoffmann-La Roche
Gram-positive, Skin Infections, Mild Eczema/Dermatoses
A Study to Evaluate Safety, Tolerability and Efficacy of Lytixar™ (LTX-109) on Uncomplicated, Gram-positive, Skin Infection
The purpose of this study is to evaluate the safety and tolerability of Lytixar™ applied topically to uncomplicated skin infections. Three dose levels of Lytixar™ (1%, 2% and 5%) versus placebo will be tested.
- Conditions
- Gram-positive, Skin Infections, Mild Eczema/Dermatoses, Atopic Dermatitis
- Trial name
- NCT01223222
- Testing
- LTX-109
- Where
- 4 sites in Hungary
- Volunteers
- 24 people
- Sponsor
- Lytix Biopharma AS
Cystic Fibrosis
Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKAYCE™) - Extension Phase
A major factor in the respiratory health of cystic fibrosis (CF) patients is acquisition of chronic Pseudomonas (P.) aeruginosa infections. The infection rate with P.
- Trial name
- NCT03905642
- Testing
- Arikayce™
- Where
- 11 sites in Belgium, Hungary and 5 more
- Volunteers
- 49 people
- Sponsor
- Insmed Incorporated
Cytomegalovirus Retinitis, HIV Infections
A Randomized Controlled Study of the Efficacy and Safety of Maintenance Treatment With Oral Ganciclovir for Newly Diagnosed Cytomegalovirus Retinitis in People With AIDS
To compare the time to progression of CMV retinitis between oral ganciclovir and IV ganciclovir during 20 weeks of maintenance treatment.
- Trial name
- NCT00002257
- Testing
- Ganciclovir
- Where
- 13 sites in United States, Canada
- Volunteers
- 150 people
- Sponsor
- Hoffmann-La Roche
Cytomegalovirus Retinitis, HIV Infections
Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis
To determine whether co-administration of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) improves tolerance to ganciclovir in patients previously intolerant because of neutropenia defined as an absolute…
- Trial name
- NCT00002070
- Testing
- Sargramostim, Ganciclovir
- Where
- 14 sites in United States
- Sponsor
- Schering-Plough
Asthma
Single Dose Study to Evaluate the Safety, and Efficacy of S-1226 (8%) in Subjects With Mild Atopic Asthma
Evaluate the safety and tolerability of a single dose of S-1226 (8%) in subjects with mild atopic asthma.
- Trial name
- S-1226(8%) (NCT02334553)
- Testing
- S1226(8%)
- Where
- Canada
- Volunteers
- 12 people
- Sponsor
- SolAeroMed Inc.
Bacterial Infections
Pharmacokinetics and Safety of Ceftobiprole in Neonates and Infants up to 3 Months Treated With Systemic Antibiotics
This study characterized the pharmacokinetics and safety of a single dose of ceftobiprole in neonates and infants aged ≤ 3 months.
- Trial name
- NCT02527681
- Testing
- Ceftobiprole medocaril
- Where
- 14 sites in United States, Belgium and 4 more
- Volunteers
- 15 people
- Sponsor
- Basilea Pharmaceutica
Leukemia, Lymphoma
Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Cord Blood Transplant for Hematologic Malignancy
Ex vivo expanded human myeloid progenitor cells (hMPCs; CLT-008) have the potential to accelerate neutrophil recovery in patients receiving myeloablative conditioning as part of an umbilical cord blood transplant for hematologic…
- Conditions
- Leukemia, Lymphoma, Multiple Myeloma, Plasma Cell Neoplasm
- Trial name
- NCT00891137
- Testing
- human myeloid progenitor cells
- Where
- 8 sites in United States
- Volunteers
- 30 people
- Sponsor
- Cellerant Therapeutics
Cystic Fibrosis
Registry to Monitor the Susceptibility to Aztreonam of Pseudomonas Aeruginosa Isolates From Cystic Fibrosis Patients
This is a prospective, longitudinal, 5-year study that will enroll participants from the existing Cystic Fibrosis Foundation (CFF) patient registry.
- Trial name
- AIR-CF5 (NCT01375036)
- Where
- 31 sites in United States
- Volunteers
- 510 people
- Sponsor
- Gilead Sciences
Treatment of Early Pulmonary Infections With P. Aeruginosa in Cystic Fibrosis Patients
Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years
This study investigated the efficacy of inhaled TOBI treatment for early infections of P. aeruginosa in paediatric patients with cystic fibrosis.
- Trial name
- EARLY (NCT01082367)
- Testing
- TOBI
- Where
- 19 sites in Canada, Egypt and 8 more
- Volunteers
- 50 people
- Sponsor
- Novartis Pharmaceuticals