The Potential Impact of Clindamycin on Neurosurgery Patients.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2023-12-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Neurologic Complication Neurosurgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group A

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

Group Type EXPERIMENTAL

Clindamycin 600 mg

Intervention Type DRUG

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

Group B

Group II patients will be managed with the standard regimen.

Group Type ACTIVE_COMPARATOR

standard regimen

Intervention Type DRUG

standard regimen

Interventions

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Clindamycin 600 mg

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

Intervention Type DRUG

standard regimen

Intervention Type DRUG

Other Intervention Names

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Dalacin 600 mg Placebo

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No