The Potential Impact of Clindamycin on Neurosurgery Patients.

Damanhour University

Status: Completed

Conditions: Neurologic Complication; Neurosurgery

Treatments: Drug: Clindamycin 600 mg; Drug: standard regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT06068673

Clindamycin in neurosurgery

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Group A

Experimental group

Description:

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

Treatment:

Drug: Clindamycin 600 mg

Group B

Active Comparator group

Description:

Group II patients will be managed with the standard regimen.

Treatment:

Drug: standard regimen