Clinical trials: Neonatal Meningitis
Meningitis
Pharmacokinetics and Safety of Meropenem in Infants Below 90 Days of Age With Probable and Confirmed Meningitis
This phase I-II multicenter international trial is designed to study the pharmacokinetics of meropenem and to characterize the safety profile of meropenem in the treatment of infants ≤ 90 days of postnatal age with probable or…
- Trial name
- NeoMero-2 (NCT01554124)
- Testing
- Meropenem
- Where
- United Kingdom
- Volunteers
- 51 people
- Sponsor
- PENTA Foundation
Neonatal Infections Colonize With Group B Streptococci
Interest of the Detection of Hyper-virulent Clone ST17 of Group B Strep (GBS) for the Prevention of Neonatal GBS Meningitis
The main objective of this study : Demonstrate that GBS (group B streptococci) "ST-17" colonize and persist to 60 days twice in the digestive tract of newborns that strains of GBS non-ST-17.
- Trial name
- Col-Strepto B (NCT01719510)
- Testing
- Samples
- Where
- 2 sites in France
- Volunteers
- 949 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Streptococcus Agalactiae Infection, Neonatal Sepsis
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
The main objective of the Phase 2 part of the trial is to assess the immunogenicity of GBS-NN/NN2 vaccine at birth in infant participants and to determine the occurrence of serious adverse events (SAEs) and adverse event of…
- Conditions
- Streptococcus Agalactiae Infection, Neonatal Sepsis, Pneumonia, Meningitis
- Trial name
- MOTIVATION (NCT07922226)
- Testing
- GBS-NN/NN2 vaccine
- Volunteers
- 6,600 people, healthy volunteers welcome
- Sponsor
- Minervax ApS
Neonate, Meningitis
Repeat Lumbar Puncture at 24 Versus 48 Hours After Traumatic Lumbar Puncture in Neonates
Visibly traumatic as well as microtraumatic lumbar punctures (LP) are very common in the neonatal period. The presence of blood makes it difficult to interpret cerebro-spinal fluid (CSF) findings.
- Conditions
- Neonate, Meningitis, Spinal Puncture
- Trial name
- NCT04794881
- Testing
- 24 hours, 48 hours
- Where
- India
- Volunteers
- 42 people
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
Meningococcal Disease
Safety and Immunogenicity of Novartis Meningococcal B Vaccine When Administered to Immunocompromised Children and Adolescents Compared to Healthy Subjects.
The study aims at evaluating the safety and immunogenicity of rMenB+OMV NZ when administered to subjects from 2 to 17 years of age with increased risk of meningococcal disease because either of primary or secondary complement…
- Trial name
- NCT02141516
- Testing
- rMenB+OMV
- Where
- 20 sites in Italy, Poland and 3 more
- Volunteers
- 239 people, healthy volunteers welcome
- Sponsor
- Novartis
Candidiasis, Systemic, Candida Meningitis
Determination of Levels of Micafungin in Neonates Suffering From Systemic Candidiasis and/or Candida Meningitis
The primary purpose of this study is to evaluate the pharmacokinetic profile of micafungin administered to neonates suffering from systemic candidiasis.
- Trial name
- NCT03421002
- Testing
- Micafungin
- Where
- 2 sites in Italy
- Volunteers
- 35 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Chorioamnionitis, Puerperal Endometritis
Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term
The aims of this study are to determine whether antibiotics administered routinely in women presenting with premature rupture of membranes later than the 37+0 weeks of gestation can alter the rate of maternal and neonatal…
- Conditions
- Chorioamnionitis, Puerperal Endometritis, Neonatal Early Onset Sepsis, Neonatal Meningitis
- Trial name
- NCT01633294
- Testing
- Ampicillin + gentamicin
- Where
- Portugal
- Volunteers
- 161 people
- Sponsor
- Hospital de Santa Maria, Portugal
Vaginal Colonization With GBS
Integrative Approach to Identify Environmental Risk Factors for CC-17 Group B Streptococcal Neonatal Infection
Streptococcus agalactiae (GBS) is the leading cause of neonatal septicaemia, meningitis, and pneumonia in the industrialized world.
- Trial name
- STREPB17 (NCT02471937)
- Testing
- Bacteriological analyses on clinical samples performed with Eswabs
- Where
- France
- Volunteers
- 151 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Meningococcal Vaccine
Trial to Describe the Safety, Tolerability, and Immunogenicity of Trumenba When Administered to Immunocompromised Participants ≥10 Years of Age
The aim of this study is to evaluate the safety, tolerability, and immunogenicity of 2 doses of Trumenba® (on a 0- and 6-month schedule) in immunocompromised participants by functionally assessing antibody production in asplenic…
- Trial name
- NCT04893811
- Testing
- Trumenba
- Where
- 14 sites in Czechia, Poland and 1 more
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Pfizer
Neonatal Meningitis
Epidemiology, Treatment and Prognosis of Neonatal Meningitis in Turkey: A Multicenter Study
Meningitis, defined as inflammation of the meninges caused by different pathogens, is a serious infection associated with high morbidity and mortality. It occurs more commonly in the neonatal period than in any other age group.
- Trial name
- NEO-MENINGITIS (NCT04009551)
- Where
- 5 sites in Turkey (Türkiye)
- Volunteers
- 500 people
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
Bacterial Infections, Urinary Tract Infections
Host RNA Profiles to Detect Infections in Young Infants
This study seeks to identify and test host RNA expression profiles as markers for infections in young infants. Preliminary studies have shown high sensitivity and specificity for the discrimination of bacterial from non-bacterial…
- Conditions
- Bacterial Infections, Urinary Tract Infections, Sepsis, Fever
- Trial name
- CHILD_YIC (NCT04823026)
- Where
- 4 sites in Denmark
- Volunteers
- 152 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Atopic Dermatitis
Equivalence of the Response to Vaccination of Tacrolimus Ointment to a Steroid Ointment Regimen in Children With Atopic Dermatitis
Seven-month study in pediatric patients (2-11 years) with moderate to severe AD who were considered to benefit from vaccination to prevent invasive disease caused by Neisseria meningitides serogroup C.
- Trial name
- NCT00801957
- Testing
- tacrolimus ointment 0.03%, hydrocortisone acetate ointment 1%, hydrocortisone butyrate ointment 0.1%
- Where
- 36 sites in Australia, Belgium and 6 more
- Volunteers
- 260 people
- Sponsor
- Astellas Pharma Inc
Meningitis, Children, Only
National Bacterial Meningitis Study in Children and Newborns
Bacterial meningitis is a major cause of morbidity and mortality in childhood. Antibiotic treatment recommendations are based on epidemiological and susceptibility data.
- Conditions
- Meningitis, Children, Only, Pneumococcal Conjugate Vaccine, Meningococcal Vaccines
- Trial name
- NCT04664569
- Where
- France
- Volunteers
- 10,000 people
- Sponsor
- Association Clinique Thérapeutique Infantile du val de Marne
Meningitis Enterovirus
Characterization of Cytokines Expression During Enterovirus Meningitis in Paediatric Populations.
Enteroviruses (EV) are the most frequent cause of acute meningitis in the paediatric population. Detection of enterovirus in cerebrospinal fluid (CSF) specimens by Polymerase Chain Reaction (PCR) is the gold standard diagnostic…
- Trial name
- Bledi-Cytokine (NCT04711876)
- Testing
- Cytokine level in blood and CSF
- Where
- France
- Volunteers
- 180 people
- Sponsor
- University Hospital, Clermont-Ferrand
Streptococcus Agalactiae Infection, Neonatal Sepsis
A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women
The main objective of the study is to evaluate the persistence of the immunoglobulin G (IgG) antibody responses, specific to Alpha-like protein CN (AlpCN), Ribosomal Protein N (RibN), Alpha-like protein 1N (Alp1N), and Alpha-like…
- Conditions
- Streptococcus Agalactiae Infection, Neonatal Sepsis, Pneumonia, Meningitis
- Trial name
- NCT06592586
- Testing
- GBS-NN/NN2 vaccine
- Where
- 6 sites in Denmark, South Africa
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- Minervax ApS
Rheumatoid Arthritis, Ankylosing Spondylitis
PatientSpot Formerly Known as ArthritisPower
Patient Power is a patient research network and database (registry) to collect prospective information about demographics, self-reported diagnoses and medications, and willingness to participate in research from participants with…
- Conditions
- Rheumatoid Arthritis, Ankylosing Spondylitis, Fibromyalgia, Gout
- Trial name
- NCT03840928
- Where
- United States
- Volunteers
- 40,000 people, healthy volunteers welcome
- Sponsor
- Global Healthy Living Foundation
Complement Deficiency, Antibody Deficiency
Systematic Search for Primary Immunodeficiency in Adults With Infections
Antibody deficiencies and complement deficiencies are the most frequent Primary immunodeficiencies (PIDs) in adults, and are associated with greatly increased susceptibility to recurrent and/or severe bacterial infections …
- Conditions
- Complement Deficiency, Antibody Deficiency, Chronic Sinus Infection, Meningitis, Bacterial
- Trial name
- SPIDAC (NCT02972281)
- Testing
- Immunological diagnosis tests
- Where
- 19 sites in France
- Volunteers
- 120 people
- Sponsor
- University Hospital, Lille
Infection
Determination of Gentamicin Dosing in Neonatal Patients
The purpose of this study is to determine what dosage of gentamicin for use in one-time administration device (Uniject) is appropriate.
- Trial name
- NCT00198601
- Testing
- Gentamicin in Uniject Pre-filled syringe
- Where
- 3 sites in Bangladesh, India and 1 more
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Infant, Newborn, Diseases, Early Onset Neonatal Sepsis
Early-Onset Sepsis an NICHD/CDC Surveillance Study
This prospective surveillance study will be conducted over a 2 year period to determine current rates of Early-Onset Sepsis (EOS)/ Early-Onset Meningitis (EOM), associated pathogens, antimicrobial resistance, signs and symptoms…
- Conditions
- Infant, Newborn, Diseases, Early Onset Neonatal Sepsis, Early-Onset Meningitis
- Trial name
- EOSII (NCT02410486)
- Where
- 20 sites in United States
- Volunteers
- 570 people
- Sponsor
- NICHD Neonatal Research Network
Pneumonia, Meningitis
Neonatal Immunization With Pneumococcal Conjugate Vaccine in Papua New Guinea
The National Health Plan 2001-2010 calls for investigation of the feasibility of pneumococcal vaccines for Papau New Guinea. The Papua New Guinea (PNG) Institute of Medical Research, the Telethon Institute for Child Health…
- Conditions
- Pneumonia, Meningitis, Otitis Media
- Trial name
- NCT00219401
- Testing
- Pneumococcal 7 valent conjugate vaccine (Prevenar®)
- Where
- Papua New Guinea
- Volunteers
- 318 people, healthy volunteers welcome
- Sponsor
- Papua New Guinea Institute of Medical Research