The Potential Impact of Clindamycin on Neurosurgery Patie... | NCT06068673

Studies
The Potential Impact of Clindamycin on Neurosurgery Patients.

NCT06068673

Sponsor

Damanhour University

Status

Completed

Last Update Posted

Jan 19, 2024Actual

Enrollment

44Actual

Phase

Not Applicable

Conditions

Neurologic Complication
Neurosurgery

Interventions

Clindamycin 600 mg
standard regimen

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2023Actual

Primary Completion Date

Dec 1, 2023Actual

Completion Date

Dec 30, 2023Actual

First Submitted Date

Sep 29, 2023

First Submission Date that Met QC Criteria

Sep 29, 2023

First Posted Date

Oct 5, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 18, 2024

Last Update Posted Date

Jan 19, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rehab Werida, Associate Professor, Damanhour UniversityPrincipal Investigator

Lead Sponsor

Damanhour UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental	Group I are patients who will receive clindamycin added-on therapy.	Drug: Clindamycin 600 mg
Group B	Active Comparator	Group II patients will be managed with the standard regimen.	Drug: standard regimen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clindamycin 600 mg	Drug	Clindamycin 900 - 1200 mg TWICE per day during 2 weeks period.	Group A

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria

1) 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rehab H Werida, Ass Prof.	Damanhour University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alexandria University Hospital		Alexandria			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002981	Clindamycin

Ancestor Terms

ID	Term
D008034	Lincomycin
D055231	Lincosamides
D011759	Pyrrolidines
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

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.