NCT Number: NCT06510751
In cases of meningitis caused by external ventricular catheters (EVDs), which are the most commonly placed intracranial catheters that can lead to central nervous system infection through contamination/colonisation, the diagnosis may not be differentiated by either clinical signs and symptoms or conventional cerebrospinal fluid (CSF) tests. Therefore, due to the limitations in diagnosis and prognostic prediction of EVD-induced meningitis and the high mortality/morbidity rates of the disease, markers with high sensitivity and specificity in post-operative meningitis are needed. Calcitonin gene-related peptide (CGRP), a neuropeptide, has been shown to increase when C or Aδ sensory fibres are damaged or in the presence of inflammation in tissues adjacent to the fibres. CGRP is localised in nociceptive nerve terminals together with another neuropeptide, substance P, which has similar biological effects. There are very few studies investigating how CGRP levels in CSF and serum change in bacterial meningitis. Although it is thought that nociception and neuroimmune interactions affect meningeal antibacterial host defence, that nociceptors signal via CGRP to meningeal immune cells during infection, and that this neuroimmune axis exacerbates bacterial meningitis by weakening host defence, it is not yet clear how CGRP and substance P levels affect disease prognosis. This study will evaluate the utility of CGRP and substance P levels as biomarkers to assess diagnosis and treatment response in patients with post-operative meningitis followed in the intensive care unit.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Antalya, Turkey (Türkiye)
Location status: Recruiting
Gul Ozbey, MD
PRINCIPAL_INVESTIGATOR
Melike Cengiz, MD
SUB_INVESTIGATOR
Oguzhan Arslan, MD
PRINCIPAL_INVESTIGATOR
Sebahat Ozdem, MD
SUB_INVESTIGATOR
Ulku Arslan Yildiz, MD
CONTACT
Ulku Arslan yildiz, MD
SUB_INVESTIGATOR
melike cengiz, Professor
CONTACT
Adult patients (18 years of age and older) with suspected CSF drainage system-related meningitis who are followed up in the Intensive Care Unit will be included in the study. Blood and CSF samples taken during routine clinical practice (before the development of meningitis symptoms, just before the first dose of antibiotherapy on the first day of meningitis symptoms, after the last dose of antibiotherapy on the 3rd day of antibiotherapy), CSF smear, CSF culture and CSF direct examination, CSF biochemistry parameters will be studied, and the materials will be taken into tubes containing aprotinin (proteinase inhibitor) to study CGRP and substance P levels in blood and CSF materials to be destroyed. CGRP and substance P levels will be analysed by ELISA method. Among the clinical parameters, the patient's state of consciousness (Glasgow coma scale), fever response, vasoactive drug requirement, organ failure, sepsis and septic shock status, SOFA and APACHE II scores will be recorded. Laboratory parameters available in routine clinical practice (haemogram, biochemical tests, microbiological growths, infection parameters), radiographic examination findings (computed brain tomography, brain magnetic resonance imaging), intensive care unit length of stay and intensive care unit outcomes (survival/mortality) will also be recorded for use in the analysis.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
CGRP and substance P levels will be analysed by ELISA method in CSF and blood materials.
Other names: Substans P level
Time frame: 16 months
The role of CGRP and substance P levels in blood and CSF samples in the diagnosis of postoperative meningitis
Time frame: 16 months
The role of CGRP and substance P levels in blood and CSF samples in the evaluation of postoperative meningitis treatment response and prediction of patient prognosis
Contact information is provided by the study sponsor or research team.
Melike Cengiz
Other
Evaluation of the Levels of Calcitonin Gene-related Peptide and Substance P in Patients With Post-operative Meningitis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07186881
Bites and Stings, Brain Diseases
Vandœuvre-lès-Nancy, Lorraine, France
View Trial DetailsNCT04823026
Bacteremia, Bacterial Infections
Copenhagen, Denmark
View Trial DetailsNCT05370573
Brain Diseases, Central Nervous System Diseases
Rio de Janeiro, Brazil
View Trial DetailsNCT07227779
Actinomycetales Infections, Bacterial Infections
Kampala, Uganda
View Trial Details