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The Potential Impact of Clindamycin on Neurosurgery Patients.

Sponsor
Damanhour University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06068673
Collaborator
(none)
44
Enrollment
1
Location
2
Arms
13
Anticipated Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Clindamycin 600 mg
  • Drug: standard regimen
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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)
Primary Purpose:
Supportive Care
Official Title:
The Potential Impact of Clindamycin on Neurosurgery Patients.
Actual Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A

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

Drug: Clindamycin 600 mg
Clindamycin 900 - 1200 mg TWICE per day during 2 weeks period.
Other Names:
  • Dalacin 600 mg

    		•
    Active Comparator: Group B

    Group II patients will be managed with the standard regimen.

    Drug: standard regimen
    standard regimen
    Other Names:
  • Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Neuron-specific enolase (NSE) Blood Concentration [2 weeks]

      Serum Level of NSE pg/ml

    2. Neurotensin Blood Concentration [2 Weeks]

      Serum Level of Neurotensin pg/ml

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alexandria University Hospital Alexandria Egypt

    Sponsors and Collaborators

    • Damanhour University

    Investigators

    • Study Chair: Rehab H Werida, Ass Prof., Damanhour University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rehab Werida, Associate Professor, Damanhour University
    ClinicalTrials.gov Identifier:
    NCT06068673
    Other Study ID Numbers:
    • Clindamycin in neurosurgery
    First Posted:
    Oct 5, 2023
    Last Update Posted:
    Oct 5, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Clindamycin
    Clindamycin palmitate
    Clindamycin phosphate

    Study Results

    No Results Posted as of Oct 5, 2023