Clinical trials: Systemic Inflammation
Gram-negative Bacterial Infections, Bloodstream Infections (BSI)
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants
The primary objectives of this study are: To assess the safety and tolerability of cefiderocol after single-dose administration in hospitalized paediatric participants 3 months to < 18 years of age with suspected or confirmed…
- Conditions
- Gram-negative Bacterial Infections, Bloodstream Infections (BSI), Complicated Intra-abdominal Infection (cIAI), Hospital Acquired Pneumonia (HAP)
- Trial name
- NCT04335539
- Testing
- Cefiderocol, Standard of Care
- Where
- 23 sites in Belgium, Estonia and 7 more
- Volunteers
- 53 people
- Sponsor
- Shionogi
Birth Asphyxia, Very Low Birth Weight Baby
Naushero Feroze Neonatal Survival Project
The present study will be carried out in close collaboration with the National Program for Lady Health Workers, a Ministry of Health program with 100,000 Lady Health Workers covering 60% of the rural population of Pakistan.
- Conditions
- Birth Asphyxia, Very Low Birth Weight Baby, Neonatal Sepsis
- Trial name
- AKU (NCT01350765)
- Testing
- Intervention, Control
- Where
- Pakistan
- Volunteers
- 37,201 people, healthy volunteers welcome
- Sponsor
- Aga Khan University
Sex Differences in Immune Response, Acute Inflammatory Diseases in Children
Study of the Sex Differences in Inflammatory Diseases in Children
Sexual differences in innate immune response have been demonstrated and were mainly attributed to the influence of the sex steroids (1-18).
- Trial name
- SepsiX (NCT04815811)
- Testing
- Blood collection, Stool collection
- Where
- Belgium
- Volunteers
- 160 people
- Sponsor
- Queen Fabiola Children's University Hospital
Neonatal Sepsis, Shock, Septic
Intravenous Methylene Blue for Treating Refractory Neonatal Septic Shock
Preterm infants (born at less than 37 weeks of pregnancy) sometimes develop a serious blood infection leading to low blood pressure, which does not respond to saline or to the standard medicines for increasing blood pressure…
- Trial name
- NCT06306001
- Testing
- Methylene Blue
- Where
- India
- Volunteers
- 130 people
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
Sepsis
Procalcitonin and Duration of AntiBiotherapy In Late Onset Sepsis of Neonate
The duration of antibiotic (ATB) therapy in late onset sepsis (LOS) of the neonate is currently not based on scientific data. The current PROABIS trial will study the use of a biological marker, procalcitonin (PCT), to guide ATB…
- Trial name
- PROABIS (NCT03730636)
- Testing
- PCT dosage
- Where
- France
- Volunteers
- 511 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Late Onset Neonatal Sepsis, Necrotising Enterocolitis
Lactoferrin Prophylaxis in VLBW and Regulator T-cells
The aim of the study is to evaluate whether oral administration of 200 mg/day lactoferrin (LF) to very low birth weight infants reduces late onset sepsis and necrotising enterocolitis and the effect of LF on regulatory T cells.
- Conditions
- Late Onset Neonatal Sepsis, Necrotising Enterocolitis, Very Low Birth Weight Infants
- Trial name
- NCT01287507
- Testing
- Lactoferrin (bovine origin)
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Ankara University
Bacteremia
Surveillance of AMR in DRC
This study addresses knowledge gaps regarding antimicrobial resistance (AMR) in sub-Saharan Africa, focusing on evaluating the feasibility of AMR surveillance and enhancing local research capacity.
- Trial name
- SARKIN (NCT06821282)
- Where
- Democratic Republic of the Congo
- Volunteers
- 210 people
- Sponsor
- University of Oxford
Still's Disease, Adult-Onset, Sepsis
Glycosylated Ferritin in Macrophagic Activation Syndromes
In healthy subjects, from 50 to 80 % of the serum ferritin is glycosylated [1, 2] . A decrease in the percentage of ferritin glycosylation can be observed in inflammatory diseases, malignancies, infections, or liver disease but…
- Conditions
- Still's Disease, Adult-Onset, Sepsis, Macrophagic Activation Syndrome
- Trial name
- FERRITGLY01 (NCT02143986)
- Where
- Belgium
- Volunteers
- 60 people
- Sponsor
- Brugmann University Hospital
Sepsis, Liver Injury
Sepsis Associated Liver Injury in Pediatric Sepsis at Assiut University Children's Hospital - 2026
This prospective cohort study aims to determine the incidence of sepsis-associated liver injury (SALI) among pediatric patients with sepsis admitted to Assiut University Children's Hospital and to evaluate its association with…
- Trial name
- NCT07832890
- Volunteers
- 158 people
- Sponsor
- Assiut University
Shock, Septic, Sepsis
Balanced Salt Solution VS. Normal Saline Solution in Septic Shock
The Purpose of this study is to determine the impact of balanced salt solution versus chloride rich solution on clinical outcomes in paediatric severe sepsis or septic shock
- Trial name
- NCT02336620
- Testing
- Ringer acetate, Normal saline
- Where
- Thailand
- Volunteers
- 60 people
- Sponsor
- Ramathibodi Hospital
Cytomegalovirus Infections, HIV Infections
Preventing Cytomegalovirus (CMV) Organ Damage With Valganciclovir in People With HIV
Cytomegalovirus (CMV) infection is a common opportunistic infection (OI) in HIV patients. The purpose of this study is to find out whether valganciclovir, an antiviral approved by the FDA for the treatment of CMV in the eye, is…
- Trial name
- NCT00006145
- Testing
- Valganciclovir
- Where
- 57 sites in United States, Puerto Rico
- Volunteers
- 350 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Pneumonia, Meningitis
Colombia Epidemiologic Surveillance Study
The study will determine the reduction in invasive pneumococcal disease (IPD) after the introduction of a National Immunization Program with PCV-7 in Bogota.
- Conditions
- Pneumonia, Meningitis, Bacteremia, Sepsis
- Trial name
- LEAP II (NCT00428051)
- Testing
- Surveillance
- Where
- 3 sites in Brazil, Colombia and 1 more
- Volunteers
- 32,867 people
- Sponsor
- Pfizer
Septic Shock, Inflammation
Pharmacology of Exenatide in Pediatric Sepsis
Pharmacology of Exenatide in Pediatric Sepsis, PEPS is a phase 1-2 research study that will examine drug safety, drug metabolism, drug action and preliminary drug clinical effects of four does of exenatide injected every 12 hours…
- Conditions
- Septic Shock, Inflammation, Glucose Homeostasis, Organ Dysfunction
- Trial name
- PEPS (NCT01573806)
- Testing
- Exenatide, Exenatide vehicle
- Where
- United States
- Sponsor
- Seattle Children's Hospital
Neonatal Sepsis
Oral Lactoferrin Supplementation for Prevention of Sepsis in Preterm Neonate
Hypothesis: Orally ingested lactoferrin has effects on promotion of growth and differentiation of the immature gut; also it has immunomodulatory properties, so it will prevent serious infections in preterm infants.
- Trial name
- NCT01821989
- Testing
- Lactoferrin
- Where
- Egypt
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Mooselmokadem
Listeriosis, Pregnancy Complications
National Study on Listeriosis and Listeria
Listeriosis is a foodborne infection responsible for severe disease. Three main forms are described: septicaemia, central nervous system infections and maternal-fetal infections.
- Conditions
- Listeriosis, Pregnancy Complications, Infectious, Central Nervous System Infections
- Trial name
- MONALISA (NCT01520597)
- Where
- France
- Volunteers
- 2,132 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Feeding; Difficult, Newborn, Growth Failure
Prophylactic Probiotics to Extremely Low Birth Weight Prematures
Mortality and incidence of severe complications is still high among extremely premature infants. Common causes of severe complications in this population are poor nutrition, necrotizing enterocolitis, and severe infections.
- Conditions
- Feeding; Difficult, Newborn, Growth Failure, Necrotizing Enterocolitis, Sepsis
- Trial name
- PROPEL (NCT01603368)
- Testing
- Lactobacillus reuteri
- Where
- 2 sites in Sweden
- Volunteers
- 134 people, healthy volunteers welcome
- Sponsor
- Ostergotland County Council, Sweden
Lupus Nephritis, Systemic Lupus Erythematosus (SLE)
Assessing Residual Inflammation and Macrophage Presence in Lupus Nephritis After 3 Months of Intensified Treatment With Prednisolone, Mycofenolate Mofetil and Voclosporin as Compared to Mycofenolate Mofetil and Prednisolone
The goal of this clinical trial is to learn how different treatments affect immune cells in the kidney in people with active lupus nephritis (LN), a kidney manifestation of systemic lupus erythematosus (SLE).
- Trial name
- MAPLE (NCT07760480)
- Testing
- Kidney Biopsy, Voclosporin (LUPKYNIS), Blood, feces and urine sample collection
- Where
- Netherlands
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Atopic Dermatitis
CBP-201 in Adolescent and Adult Patients With Moderate-to-severe Atopic Dermatitis
This is a Phase 3, randomized, double-blinded, placebo-controlled trial in patients, ≥12 years of age who weigh ≥40 kg, and are diagnosed with moderate-to-severe AD.
- Trial name
- NCT05614817
- Testing
- CBP-201
- Sponsor
- Connect Biopharm LLC
Sepsis, Infections
Bacillus Cereus Invasive Infections in Preterm Neonates Hospitalized in French Hospitals
Background. Bacillus cereus group (Bc) comprises twenty-six closely related species of spore-forming environmental bacteria. Recently, increased sepsis and septic shock caused by Bc were reported in preterm neonates (PN), and the…
- Trial name
- NCT06973174
- Testing
- Premature neonates with invasive infection caused by Bacillus cereus
- Where
- 13 sites in France
- Volunteers
- 40 people
- Sponsor
- Centre Hospitalier Universitaire de Nice
Acute Lymphoblastic Leukemia, Immune System Diseases
Administration of Autologous CAR-T CD19 Antigen With Inducible Safety Switch in Patients With Relapsed/Refractory ALL
The body has different ways of fighting infection and disease. No single way is effective at fighting cancer. This research study combines two different ways of fighting disease: antibodies and T cells.
- Conditions
- Acute Lymphoblastic Leukemia, Immune System Diseases, Immunoproliferative Disorders
- Trial name
- NCT03016377
- Testing
- iC9-CAR19 cells, Rimiducid, Cyclophosphamide
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center