The Potential Impact of Clindamycin on Neurosurgery Patients.

January 18, 2024 updated by: Rehab Werida, Damanhour University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Alexandria University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuron-specific enolase (NSE) Blood Concentration
Time Frame: 2 weeks
Serum Level of NSE pg/ml
2 weeks
Neurotensin Blood Concentration
Time Frame: 2 Weeks
Serum Level of Neurotensin pg/ml
2 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damanhour University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

December 30, 2023

Study Registration Dates

First Submitted

September 29, 2023

First Submitted That Met QC Criteria

September 29, 2023

First Posted (Actual)

October 5, 2023

Study Record Updates

Last Update Posted (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Clindamycin in neurosurgery

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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