The Potential Impact of Clindamycin on Neurosurgery Patients.

Neurosurgery Clinical Trial

Official title:

The Potential Impact of Clindamycin on Neurosurgery Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06068673
• Other study ID #: Clindamycin in neurosurgery
• Status: Completed
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: January 2024
• Source: Damanhour University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 30, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion criteria

1) Adult patients will be enrolled if they underwent neurosurgery or presented with clinical signs of meningitis.

Exclusion criteria

1. Age lower than 18.

2. Females with a positive pregnancy test.

3. Known congestive heart failure or ischemic heart disease.

4. Any injury that disturbs the examination (high cervical cord injury or locked-in syndrome, could be a source of bias).

5. Severe brain disease (For example CVA history or brain tumor).

6. Renal failure with GFR lower than 60 ml/min.

7. Patients with unknown identity.

Related Conditions & MeSH terms

• Neurologic Complication
• Neurosurgery

Intervention

Drug:
• Clindamycin 600 mg
Clindamycin 900 - 1200 mg TWICE per day during 2 weeks period.
• standard regimen
standard regimen

Locations

Country	Name	City	State
Egypt	Alexandria University Hospital	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Damanhour University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuron-specific enolase (NSE) Blood Concentration	Serum Level of NSE pg/ml	2 weeks
Primary	Neurotensin Blood Concentration	Serum Level of Neurotensin pg/ml	2 Weeks