The Potential Impact of Clindamycin on Neurosurgery Patients.

NCT06068673 | Completed

• 1 other identifier: Clindamycin in neurosurgery
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurologic Complication; Neurosurgery

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Group A

EXPERIMENTAL

Group I are patients who will receive clindamycin added-on therapy.

Drug: Clindamycin 600 mg

Group B

ACTIVE COMPARATOR

Group II patients will be managed with the standard regimen.

Drug: standard regimen

Interventions

Clindamycin 600 mg DRUG

Clindamycin 900 - 1200 mg TWICE per day during 2 weeks period.

Also known as: Dalacin 600 mg

Group A

standard regimen DRUG

standard regimen

Also known as: Placebo

Group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damanhour University: lead

Study Sites (1)

Alexandria University Hospital

Alexandria, Egypt

Location

MeSH Terms

Interventions

Clindamycin

Intervention Hierarchy (Ancestors)

Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates

Study Officials

• Rehab H Werida, Ass Prof.

  Damanhour University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: October 5, 2023
• Study Start: March 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 30, 2023
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)