Neurologic ComplicationNCT06068673
The Potential Impact of Clindamycin on Neurosurgery Patients.
A study testing Clindamycin 600 mg and standard regimen in people with Neurologic Complication and Neurosurgery, run by Damanhour University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neurologic Complication, Neurosurgery
- What is being tested?
- Clindamycin 600 mg and standard regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Adult patients will be enrolled if they underwent neurosurgery or presented with clinical signs of meningitis.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Neurologic Complication, Neurosurgery
- Being tested
- Clindamycin 600 mg, standard regimen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clindamycin 600 mgDrug
Also called Dalacin 600 mg
Clindamycin 900 - 1200 mg TWICE per day during 2 weeks period.
standard regimenDrug
Also called Placebo
standard regimen
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group I are patients who will receive clindamycin added-on therapy. Receives: Drug: Clindamycin 600 mg |
| Group B | Active comparator | Group II patients will be managed with the standard regimen. Receives: Drug: standard regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuron-specific enolase (NSE) Blood Concentration
Serum Level of NSE pg/ml
Measured: 2 weeks
Neurotensin Blood Concentration
Serum Level of Neurotensin pg/ml
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start1 Mar 2023
- Primary completion1 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurologic ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Werida, Damanhour University
- Investigators
- Rehab H Werida, Ass Prof., Study chair, Damanhour University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068673
- Sponsor's protocol ID
- Clindamycin in neurosurgery
- Status last verified
- Jan 2024
- First submitted
- 29 Sep 2023
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Impact of Clindamycin on Neurosurgery Patients.
- ClinicalTrials.gov ID
- NCT06068673
- Acronym / sponsor ID
- Clindamycin in neurosurgery
- Conditions
- Neurologic Complication, Neurosurgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 5 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Clindamycin 600 mgGroup I are patients who will receive clindamycin added-on therapy. |
| Group B | Active comparator | Drug: standard regimenGroup II patients will be managed with the standard regimen. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Adult patients will be enrolled if they underwent neurosurgery or presented with clinical signs of meningitis.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clindamycin 600 mgAlso: Dalacin 600 mgClindamycin 900 - 1200 mg TWICE per day during 2 weeks period. | Drug | Group A |
| standard regimenAlso: Placebostandard regimen | Drug | Group B |
Primary outcome
Neuron-specific enolase (NSE) Blood Concentration
Time frame: 2 weeks
Serum Level of NSE pg/ml
Neurotensin Blood Concentration
Time frame: 2 Weeks
Serum Level of Neurotensin pg/ml
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rehab H Werida, Ass Prof. study chair
Damanhour University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clindamycin 600 mg and standard regimen in people with Neurologic Complication and Neurosurgery, run by Damanhour University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuron-specific enolase (NSE) Blood Concentration (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.