The Potential Impact of Clindamycin on Neurosurgery Patients.

Study Overview
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Brief Summary
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A prospective, open-label, single center, controlled trial. 44 patients that underwent neurosurgery or presented meningitis signs, for whom Clindamycin add-on therapy to assess its effect on neurological complication in relation to Neuron-specific enolase (NSE) and Neurotensin biomarkers levels.

Detailed Description
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This is a prospective, open-label, single center, controlled trial. 44 patients that underwent neurosurgery or presented meningitis signs, for whom Clindamycin add-on therapy is prescribed (900 - 1200 mg twice daily) will be recruited from Alexandria University Main Hospital. Whole blood samples will be collected for Analyses of Neuron-specific enolase (NSE) and Neurotensin will be detected by ELISA. All patients will be assessed for complete blood count (CBC), kidney function, liver function, Methodology Patients will be enrolled if they underwent surgery or presented with clinical signs of meningitis. All enrolled 44 patients will be divided into two groups; Group I are patients who will receive clindamycin added-on therapy. Group II patients will be managed with the standard regimen. Complete physical, laboratory, and radiological assessment will be done for all patients All patients will be followed up during 2 weeks period. Serum samples will be collected for measuring the biomarkers.

Official Title
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The Potential Impact of Clindamycin on Neurosurgery Patients.

Conditions
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Neurologic Complication, Neurosurgery

Intervention / Treatment
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* Drug: Clindamycin 600 mg
* Drug: standard regimen


Participation Criteria
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Eligibility Criteria
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Inclusion criteria 1) Adult patients will be enrolled if they underwent neurosurgery or presented with clinical signs of meningitis. Exclusion criteria Age lower than 18. Females with a positive pregnancy test. Known congestive heart failure or ischemic heart disease. Any injury that disturbs the examination (high cervical cord injury or locked-in syndrome, could be a source of bias). Severe brain disease (For example CVA history or brain tumor). Renal failure with GFR lower than 60 ml/min. Patients with unknown identity.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All enrolled 44 patients will be divided into two groups; Group I are patients who will receive clindamycin added-on therapy. Group II patients will be managed with the standard regimen.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Group I are patients who will receive clindamycin added-on therapy. | Drug: Clindamycin 600 mg<br>* Clindamycin 900 - 1200 mg TWICE per day during 2 weeks period.<br>* Other names: Dalacin 600 mg;|
| Active Comparator: Group B<br>Group II patients will be managed with the standard regimen. | Drug: standard regimen<br>* standard regimen<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuron-specific enolase (NSE) Blood Concentration | Serum Level of NSE pg/ml | 2 weeks | 
| Neurotensin Blood Concentration | Serum Level of Neurotensin pg/ml | 2 Weeks |