The Potential Impact of Clindamycin on Neurosurgery Patients.

Not Applicable

Completed

• Conditions: Neurologic Complication; Neurosurgery
• Interventions: Drug: standard regimen; Drug: Clindamycin 600 mg

• Registration Number: NCT06068673
• Lead Sponsor: Damanhour University

Brief 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.

Study Timeline

• Study Start: 2023-03-01
• Study First Submitted: 2023-09-29
• Study First Submitted QC: 2023-09-29
• Study First Posted: 2023-10-05
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-18
• Last Update Posted: 2024-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	standard regimen	Group II patients will be managed with the standard regimen.
Group A	Clindamycin 600 mg	Group I are patients who will receive clindamycin added-on therapy.

Primary Outcome Measures

Name	Time	Method
Neuron-specific enolase (NSE) Blood Concentration	2 weeks	Serum Level of NSE pg/ml
Neurotensin Blood Concentration	2 Weeks	Serum Level of Neurotensin pg/ml

Trial Locations

Locations (1)

Alexandria University Hospital; 🇪🇬 Alexandria, Egypt