Clinical trials: Neonatal Infections
Malaria, Vivax
A Pharmacokinetics, Safety and Efficacy Study of Tafenoquine (TQ) in Pediatric Subjects With Plasmodium Vivax (P. Vivax) Malaria
This is a prospective, open-label, multicenter, non-comparative, single arm study of pediatric subjects with Plasmodium vivax (P. vivax) malaria, aged 6 months to <16 years of age. A total of 60 subjects will be enrolled.
- Trial name
- NCT02563496
- Testing
- Tafenoquine, Chloroquine
- Where
- 4 sites in Colombia, Vietnam
- Volunteers
- 60 people
- Sponsor
- GlaxoSmithKline
Duchenne Muscular Dystrophy, Spinal Muscular Atrophy
Flu Vaccine Study in Neuromuscular Patients 2011
The purpose of the study is to compare the immune response of two different injection methods (Intramuscular V.S. Subcutaneous) of the 2011-2012 seasonal Influenza (Flu) vaccine among patients with neuromuscular conditions who…
- Conditions
- Duchenne Muscular Dystrophy, Spinal Muscular Atrophy, Congenital Muscular Dystrophy
- Trial name
- NCT01422200
- Testing
- 2011-2012 seasonal flu vaccine Subcutaneous, 2011-2012 seasonal flu vaccine Intramuscular
- Volunteers
- 22 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Chronic Myeloproliferative Disorders, Leukemia
Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Diseases
RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and melphalan, before a donor peripheral stem cell transplant or bone marrow transplant helps stop the growth of cancer or abnormal cells.
- Conditions
- Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm
- Trial name
- NCT00453206
- Testing
- allogeneic bone marrow transplantation, allogeneic hematopoietic stem cell transplantation, nonmyeloablative allogeneic hematopoietic stem cell transplantation
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- Wake Forest University Health Sciences
Cystic Fibrosis
Dose Escalation Study of KB001 in Cystic Fibrosis Patients Infected With Pseudomonas Aeruginosa
The primary objective of this study is to evaluate the safety and tolerability of a single dose of KB001 in Cystic Fibrosis patients infected with Pseudomonas aeruginosa (Pa)
- Trial name
- NCT00638365
- Testing
- KB001
- Where
- 11 sites in United States
- Volunteers
- 27 people
- Sponsor
- Humanigen, Inc.
Respiratory Syncytial Virus Infection
Synagis® Liquid 50mg, 100mg for Intramuscular Injection Special Investigation in Immunocompromised Children With Synagis®
This post marketing observational study (PMOS) was conducted in Japan during the 2013-2014 and 2014-2015 Respiratory Syncytial Virus (RSV) seasons to assess the safety and effectiveness of palivizumab for the prevention of…
- Trial name
- NCT02016690
- Volunteers
- 312 people
- Sponsor
- AbbVie
Hemophagocytic Lymphohistiocytosis, Chronic Active Epstein-Barr Virus Infection
Reduced Intensity Conditioning for Hemophagocytic Syndromes or Selected Primary Immune Deficiencies (BMT CTN 1204)
HLH, HLH-related disorders, Chronic Granulomatous (CGD), HIGM1, Immune dysregulation, polyendocrinopathy, enteropathy, and X-linked inheritance (IPEX) and severe LAD-I represent primary immune disorders that are typically fatal…
- Conditions
- Hemophagocytic Lymphohistiocytosis, Chronic Active Epstein-Barr Virus Infection, Chronic Granulomatous Disease, HIGM-1
- Trial name
- RICHI (NCT01998633)
- Testing
- Hematopoietic Stem Cell Transplant
- Where
- 22 sites in United States, Canada
- Volunteers
- 47 people
- Sponsor
- Medical College of Wisconsin
Staph Aureus Colonization, Staph Aureus Infection
Treating Parents to Reduce NICU Transmission of Staphylococcus Aureus Trial
This trial will test the hypothesis that treating parents of neonates requiring NICU care with intranasal mupirocin and topical chlorhexidine bathing will reduce the spread of S. aureus from parents to neonates.
- Trial name
- TREAT PARENTS (NCT02223520)
- Testing
- Mupirocin and Chlorhexidine
- Where
- 2 sites in United States
- Volunteers
- 307 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Neonatal Sepsis
Late-onset Sepsis in Term and Pre-term Neonates and Infants up to 3 Months of Age
This study evaluated the safety, pharmacokinetics and efficacy of ceftobiprole in term and pre-term newborn babies and infants up to 3 months of age with late-onset sepsis (LOS).
- Trial name
- NCT05856227
- Testing
- Ceftobiprole medocaril
- Where
- 14 sites in United States, Bulgaria and 6 more
- Volunteers
- 9 people
- Sponsor
- Basilea Pharmaceutica
Respiratory Tract Infections
A Study of Rilematovir in Infants and Children and Subsequently in Neonates Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV)
The purpose of the study is to evaluate the efficacy of rilematovir compared to placebo treatment with respect to the clinical outcome on the RSV Recovery Scale (RRS).
- Trial name
- DAISY (NCT04583280)
- Testing
- Rilematovir, Rilematovir X mg/kg
- Where
- 142 sites in United States, Argentina and 24 more
- Volunteers
- 28 people
- Sponsor
- Janssen Research & Development, LLC
Maternal Death, Maternal Infections Affecting Fetus or Newborn
Azithromycin-Prevention in Labor Use Study (A-PLUS)
Maternal and neonatal infections are among the most frequent causes of maternal and neonatal deaths, and current antibiotic strategies have not been effective in preventing many of these deaths.
- Conditions
- Maternal Death, Maternal Infections Affecting Fetus or Newborn, Neonatal SEPSIS, Maternal Sepsis During Labor
- Trial name
- NCT03871491
- Testing
- Azithromycin
- Where
- 8 sites in Bangladesh, Democratic Republic of the Congo and 5 more
- Volunteers
- 58,747 people, healthy volunteers welcome
- Sponsor
- NICHD Global Network for Women's and Children's Health
Chronic Myeloproliferative Disorders, Leukemia
Busulfan, Fludarabine, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Stem Cell Transplant for Hematologic Cancer
RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells.
- Conditions
- Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm
- Trial name
- Bu Flu TBI (NCT00245037)
- Testing
- therapeutic allogeneic lymphocytes, busulfan, cyclosporine
- Where
- United States
- Volunteers
- 147 people
- Sponsor
- OHSU Knight Cancer Institute
Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission
Plerixafor and Filgrastim For Mobilization of Donor Peripheral Blood Stem Cells Before A Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
RATIONALE: Giving chemotherapy and total-body irradiation (TBI) before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem…
- Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
- Trial name
- NCT01076270
- Testing
- plerixafor, filgrastim, peripheral blood stem cell transplantation
- Where
- United States
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- Fred Hutchinson Cancer Center
Human Immunodeficiency Virus, Acquired Immunodeficiency Syndrome
Self-Test Strategies and Linkage Incentives to Improve ART and PrEP Uptake in Men
This is a randomized controlled trial to test a combination behavioral and biomedical interventions to improve the HIV prevention and care cascades in a population of mobile men in a high priority setting (fishermen in Kenya).
- Conditions
- Human Immunodeficiency Virus, Acquired Immunodeficiency Syndrome, HIV Infections, Sexually Transmitted Diseases, Viral
- Trial name
- NCT04772469
- Testing
- Provision of multiple self-tests, Small monetary incentives, Use of SMS/text reminders to motivate adherence to ART or PrEP
- Where
- Kenya
- Volunteers
- 934 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Graft Versus Host Disease, Leukemia
Treatment of Single or Double Umbilical Cord Trans + Graft-versus-host Disease (GVHD) Prophylaxis w/ Tacrolimus & Mycophenolate Mofetil
RATIONALE: Giving chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's…
- Conditions
- Graft Versus Host Disease, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm
- Trial name
- NCT00608517
- Testing
- anti-thymocyte globulin, cyclophosphamide, fludarabine phosphate
- Where
- 4 sites in United States
- Volunteers
- 6 people
- Sponsor
- Vanderbilt-Ingram Cancer Center
Acute Uncomplicated Falciparum Malaria
Efficacy, Safety and Pharmacokinetics of Artemether-lumefantrine Dispersible Tablet in the Treatment of Malaria in Infants < 5 kg
The purpose of the study is to obtain efficacy, safety and pharmacokinetic (PK) data following treatment with artemether-lumefantrine dispersible tablet in infants < 5 kg of body weight (BW) with uncomplicated falciparum malaria.
- Trial name
- NCT01619878
- Testing
- Artemether-lumefantrine (COA566)
- Where
- 7 sites in Benin, Burkina Faso and 3 more
- Volunteers
- 20 people
- Sponsor
- Novartis Pharmaceuticals
Accelerated Phase Chronic Myelogenous Leukemia, Acute Undifferentiated Leukemia
Fludarabine and Total-Body Irradiation Followed By Donor Stem Cell Transplant and Cyclosporine and Mycophenolate Mofetil in Treating HIV-Positive Patients With or Without Cancer
This clinical trial studies the side effects and best dose of giving fludarabine and total-body irradiation (TBI) together followed by a donor stem cell transplant and cyclosporine and mycophenolate mofetil in treating human…
- Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, Acute Undifferentiated Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission
- Trial name
- NCT00112593
- Testing
- fludarabine phosphate, total-body irradiation, peripheral blood stem cell transplantation
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Fred Hutchinson Cancer Center
Acute Undifferentiated Leukemia, Adult Acute Lymphoblastic Leukemia in Remission
Deferasirox in Treating Iron Overload Caused By Blood Transfusions in Patients With Hematologic Malignancies
RATIONALE: Deferasirox may remove excess iron from the body caused by blood transfusions. PURPOSE: This clinical trial studies deferasirox in treating iron overload caused by blood transfusions in patients with hematologic…
- Conditions
- Acute Undifferentiated Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
- Trial name
- NCT01273766
- Testing
- deferasirox, laboratory biomarker analysis, enzyme-linked immunosorbent assay
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Wake Forest University Health Sciences
Cystic Fibrosis, Pulmonary Disease, Chronic Obstructive
Comparison of Two Treatment Regimens to Reduce PA Infection in Children With Cystic Fibrosis
Cystic fibrosis (CF) is a chronic disease that significantly affects an individual's lung function. Antibiotic medications have been proven effective at reducing Pseudomonas aeruginosa (PA) infection, which is one of the main…
- Trial name
- EPIC (NCT00097773)
- Testing
- Tobramycin solution for inhalation (TOBI), Oral ciprofloxacin
- Where
- 54 sites in United States
- Volunteers
- 304 people
- Sponsor
- Seattle Children's Hospital
Cystic Fibrosis
A Study of Tobramycin Inhalation Powder From a Modified Manufacturing Process Versus Placebo
This study is designed to show how well tobramycin inhalation powder works and how safe it is when produced by a modified manufacturing process
- Trial name
- EDIT (NCT00918957)
- Testing
- Tobramycin Inhalation Powder
- Where
- 24 sites in Bulgaria, Egypt and 7 more
- Volunteers
- 62 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Myeloproliferative Disorders, Leukemia
Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer Who Are Undergoing Donor Stem Cell Transplant
RATIONALE: Giving low doses of chemotherapy, monoclonal antibodies, and radiation therapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells.
- Conditions
- Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm
- Trial name
- NCT00691015
- Testing
- rituximab, busulfan, carmustine
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Barbara Ann Karmanos Cancer Institute