Implant Infection Clinical Trial
Official title:
Early Diagnosis and Treatment Monitoring of Native and Device-associated Meningitis Using D-lactate, a Pathogen-specific Diagnostic Biomarker in Cerebrospinal Fluid
NCT number | NCT05146570 |
Other study ID # | DIAMEN |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2021 |
Est. completion date | May 31, 2024 |
Device-associated meningitis is a severe complication after implantation of various central nervous system (CNS) devices such as ventriculoperitoneal (VP) and ventriculoatrial (VA) shunts, external ventricular drains (EVD), lumbar drains (ELD) and intrathecal pumps. In contrast to native meningitis, these infections are hard to diagnose both clinically and on the laboratory basis due to (i) atypical clinical manifestation, (ii) overlapping inflammation following surgery, and (iii) common culture negativity due to previous antibiotic therapy and slow growth of low-virulent pathogens. Also, device-associated infections are difficult to differentiate from aseptic shunt failure (dysfunction) or "chemical meningitis" caused by underlying neurosurgical condition that prompted the placement of the CNS device (e.g. intracranial hemorrhage). Both native and device-associated meningitis carry substantial morbidity and mortality. Rapid and reliable diagnosis of meningitis is critical for initiating and choosing optimal treatment and minimizing the brain damage. Since treatment is different in septic than aseptic meningitis, it is paramount to diagnose or exclude septic meningitis as soon as possible. Several new diagnostic methods, such as cerebrospinal fluid (CSF) procalcitonin, interleukin-6 and polymerase chain reaction (PCR) have been proposed for rapid diagnosis of meningitis. However, insufficient sensitivity and/or specificity, long time until test result, and complexity in handling or interpretation of results limit their use in clinical routine. In previous studies CSF D-lactate test showed good specificity and sensitivity in patients with native meningitis. This biomarker is pathogen-specific - in contrast to other currently used host-specific biomarkers (leukocyte count, L-lactate, procalcitonin). However, no study on effectiveness of D-lactate test for the diagnosis of device-associated meningitis has been performed. Successful management of device-associated meningitis depends upon appropriate control of the infectious complications. To deal with such complications, adequate assessment and prediction of the clinical course are needed. Another use of D-lactate test could be his role as prognostic factor of the clinical course of device-associated meningitis.
Status | Recruiting |
Enrollment | 842 |
Est. completion date | May 31, 2024 |
Est. primary completion date | May 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria: - patients with suspected (clinical, paraclinical or radiological) native or device-associated meningitis - age >18 years - patient signs written consent to participate in the study Exclusion criteria: - inability of the patient or family member to consent to the study - time from puncture to laboratory evaluation> 24 hours |
Country | Name | City | State |
---|---|---|---|
Germany | Charité Universitätsmedizin Berlin | Berlin |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany |
Germany,
Banks JT, Bharara S, Tubbs RS, Wolff CL, Gillespie GY, Markert JM, Blount JP. Polymerase chain reaction for the rapid detection of cerebrospinal fluid shunt or ventriculostomy infections. Neurosurgery. 2005 Dec;57(6):1237-43; discussion 1237-43. — View Citation
Chen Z, Wang Y, Zeng A, Chen L, Wu R, Chen B, Chen M, Bo J, Zhang H, Peng Q, Lu J, Meng QH. The clinical diagnostic significance of cerebrospinal fluid D-lactate for bacterial meningitis. Clin Chim Acta. 2012 Oct 9;413(19-20):1512-5. doi: 10.1016/j.cca.2012.06.018. Epub 2012 Jun 17. — View Citation
Conen A, Walti LN, Merlo A, Fluckiger U, Battegay M, Trampuz A. Characteristics and treatment outcome of cerebrospinal fluid shunt-associated infections in adults: a retrospective analysis over an 11-year period. Clin Infect Dis. 2008 Jul 1;47(1):73-82. doi: 10.1086/588298. — View Citation
Hasbun R. Central Nervous System Device Infections. Curr Infect Dis Rep. 2016 Nov;18(11):34. doi: 10.1007/s11908-016-0541-x. Review. — View Citation
Horan TC, Andrus M, Dudeck MA. CDC/NHSN surveillance definition of health care-associated infection and criteria for specific types of infections in the acute care setting. Am J Infect Control. 2008 Jun;36(5):309-32. doi: 10.1016/j.ajic.2008.03.002. Erratum in: Am J Infect Control. 2008 Nov;36(9):655. — View Citation
Li Y, Zhang G, Ma R, Du Y, Zhang L, Li F, Fang F, Lv H, Wang Q, Zhang Y, Kang X. The diagnostic value of cerebrospinal fluids procalcitonin and lactate for the differential diagnosis of post-neurosurgical bacterial meningitis and aseptic meningitis. Clin Biochem. 2015 Jan;48(1-2):50-4. doi: 10.1016/j.clinbiochem.2014.10.007. Epub 2014 Oct 30. — View Citation
van de Beek D, Drake JM, Tunkel AR. Nosocomial bacterial meningitis. N Engl J Med. 2010 Jan 14;362(2):146-54. doi: 10.1056/NEJMra0804573. Review. — View Citation
Walti LN, Conen A, Coward J, Jost GF, Trampuz A. Characteristics of infections associated with external ventricular drains of cerebrospinal fluid. J Infect. 2013 May;66(5):424-31. doi: 10.1016/j.jinf.2012.12.010. Epub 2013 Jan 9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Performance of D-lactate test for the diagnosis of native and device-associated meningitis. | Determined performance (D-lactate cut-off value, sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio) of D-lactate test.
The Mann-Whitney test and Spearman's correlation will be applied to analyze the quantitative variables. Youden's J statistic will be used for determining optimal D-lactate cut-off value on the receiver operating characteristic (ROC) curve by maximizing sensitivity and specificity. The area under the ROC curves will be calculated to compare the D-lactate test performance. |
up to 30 months | |
Secondary | Performance of the D-lactate test in comparison with standard tests for the diagnosis of native and device-associated meningitis. | Identified differences between performance of D-lactate test and standard tests (cultures, cell counting, Gram preparations, L-lactate, protein and glucose) for the diagnosis of native and device-associated meningitis.
- To compare the performances of different tests (sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio) the McNemar chi-square will be used. |
up to 30 months | |
Secondary | Treatment monitoring using D-lactate test (as a predictor of treatment success / failure). | Number of participants with cured (or recurrent) native and device-associated meningitis assed by D-lactate test and with standard diagnostic criteria.
D-lactate test will be judged positive or negative according to the established cut-off in Outcome 1. Standard methods include standard diagnostic criteria for device-associated meningitis according to modified criteria for nosocomial infections from Centers for Disease Control and Prevention (CDC) and standard diagnostic criteria for native meningitis (according to study description). |
up to 30 months |
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