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Clinical trial

The Potential Impact of Clindamycin on Neurosurgery Patients.

ID
Name
Clindamycin in neurosurgery
Description
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.
Trial arms
Trial start
2023-03-01
Estimated PCD
2023-12-01
Trial end
2023-12-30
Status
Completed
Treatment
Clindamycin 600 mg
Clindamycin 900 - 1200 mg TWICE per day during 2 weeks period.
Arms:
Group A
Other names:
Dalacin 600 mg
standard regimen
standard regimen
Arms:
Group B
Other names:
Placebo
Size
44
Primary endpoint
Neuron-specific enolase (NSE) Blood Concentration
2 weeks
Neurotensin Blood Concentration
2 Weeks
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 44, 'type': 'ACTUAL'}}
Updated at
2024-01-19

1 organization

2 products

2 indications

Organization
Damanhour University
Product
Clindamycin
Indication
Neurological Complication
Indication
Neurosurgery
Product
Standard Regimen