NCT06068673

The Potential Impact of Clindamycin on Neurosurgery Patients.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Damanhour University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

1. 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. 2. Whole blood samples will be collected for Analyses of Neuron-specific enolase (NSE) and Neurotensin will be detected by ELISA. 3. 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.

Conditions

• Neurologic Complication
• Neurosurgery

Interventions

Type	Name	Description
DRUG	Clindamycin 600 mg	Clindamycin 900 - 1200 mg TWICE per day during 2 weeks period.
DRUG	standard regimen	standard regimen

Timeline

• Start date: 2023-03-01
• Primary completion: 2023-12-01
• Completion: 2023-12-30
• First posted: 2023-10-05
• Last updated: 2024-01-19

Locations

1 site across 1 country: Egypt