Evaluation of the Levels of Calcitonin Gene-related Peptide and Substance P

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMelike Cengiz

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18 years and over

Patients followed up in the intensive care unit with suspected meningitis

Disqualifiers

Patients under 18 years of age

Patients with suspected meningitis in the intensive care unit who have not undergone neurosurgical operation and do not have CSF drainage catheter

Trial population

Postoperative meningitis patients

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • CGRP level

    Other intervention

    CGRP and substance P levels will be analysed by ELISA method in CSF and blood materials.

Treatment groups

51 Participants
are divided into 2 treatment groups
Group A: Postoperative meningitis mortality1 intervention
Group B: Postoperative meningitis survival1 intervention

Trial outcomes

Primary outcomes

1

Diagnosis

The role of CGRP and substance P levels in blood and CSF samples in the diagnosis of postoperative meningitis

Time frame
16 months

Secondary outcomes

1

Prognosis

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

Time frame
16 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Melike Cengiz

Lead sponsor

Akdeniz University

Sponsor institution