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OpenTrials
Completed

NCT Number: NCT06068673

The Potential Impact of Clindamycin on Neurosurgery Patients.

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.

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Key information

Conditions

Neurologic Complication Neurosurgery

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria University Hospital

Alexandria, Egypt

About this study

  • 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.
  • Whole blood samples will be collected for Analyses of Neuron-specific enolase (NSE) and Neurotensin will be detected by ELISA.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Clindamycin 600 mg

Drug

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

Other names: Dalacin 600 mg

Standard regimen

Drug

standard regimen

Other names: Placebo

Primary outcomes

  1. Neuron-specific enolase (NSE) Blood Concentration

    Time frame: 2 weeks

    Serum Level of NSE pg/ml

  2. Neurotensin Blood Concentration

    Time frame: 2 Weeks

    Serum Level of Neurotensin pg/ml

Sponsors and collaborators

Lead sponsor

Damanhour University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 5, 2023
Registry last updated
Jan 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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