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Doxycycline in Acute Traumatic Brain Injury

Sponsor
Damanhour University (Other)
Overall Status
Completed
CT.gov ID
NCT04239755
Collaborator
Tanta University (Other)
50
Enrollment
1
Location
2
Arms
8.9
Actual Duration (Months)
5.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

evaluate the impact of Doxycycline on both clinical outcome and blood levels of NSE in patients with TBI.

Condition or Disease Intervention/Treatment Phase
  • Drug: Doxycycline 100 MG Oral Tablet
  • Other: placebo
 Phase 4

Detailed Description

  1. Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damnhour University.

  2. All Participants agreed to take part in this clinical research and provide informed consent. for unconscious participants, the informed consent was obtained from their legally authorized representative.

  3. Patients with moderate to severe TBI will be enrolled from Tanta university hospitals.

  4. Serum samples will be collected for measuring the biomarkers.

  5. Our design is randomized, controlled study.

  6. All enrolled patients will be divided into 2 groups, Group (1) 25 patients that receive doxycycline 100 mg twice daily, either orally or through a nasogastric tube for 5 days, and group (2) will be 25 patients will receive placebo in addition to the standard treatment.

  7. All patients will be followed up during ICU period.

  8. Statsicial tests appropriate to the study design will be conducted to evaluate the significance of the results.

  9. Measuring outcome: the primary outcome is the change in the serum level of acute brain injury biomarkers.

  10. Results, conclusions, discussion and recommendations will be given.

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Doxycycline Effects on Neurological Outcomes in Patients With Acute Traumatic Brain Injury
Actual Study Start Date :
Feb 1, 2020
Actual Primary Completion Date :
Jul 30, 2020
Actual Study Completion Date :
Oct 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Doxycycline

Group (1) 25 patients that receive doxycycline 100 mg twice daily, either orally or through a nasogastric tube for 5 days.

Drug: Doxycycline 100 MG Oral Tablet
doxycycline 100 mg twice daily, either orally or through a nasogastric tube for 5 day
Other Names:
  • vibramycine

    		•
    Placebo Comparator: Placebo

    group (2) will be 25 patients will receive placebo in addition to the standard treatment.

    Other: placebo
    placebo in addition to the standard treatment.

    Outcome Measures

    Primary Outcome Measures

    1. Neuron specific enolase [7 days]

      levels of NSE

    2. Glasgow Coma Scale (GCS) [7 days]

      Glasgow Coma Scale (GCS) 15 Points Normal:3 Points Abnormal

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Hospital admission in the first 24 h of injury,

    2. 18 to 90 years of age and

    3. Both sexes with moderate to severe traumatic brain injury (GCS score ≤ 12).

    4. Able to tolerate enteral feeding and drug administration within the first 24 hours of TBI

    Exclusion Criteria:

    1. Hypersensitivity to tetracyclines

    2. Pregnant and breast feeding women,

    3. History of autoimmune disease.

    4. History of receiving chronic steroid treatment and isotretinoin,

    5. Pre-existing hepatic (AST, ALT greater than 3 times the upper limit of normal) or renal failure (BUN/ Creatinine 20:1; creatinine > 2 mg/dL),

    6. Known malignancies

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tanta University Hospital Tanta El-Gharbia Egypt 31527

    Sponsors and Collaborators

    • Damanhour University
    • Tanta University

    Investigators

    • Principal Investigator: Noha Mansour, Lecturer, Mansoura University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rehab Werida, Clinical Pharmacy Lecturer, Damanhour University
    ClinicalTrials.gov Identifier:
    NCT04239755
    Other Study ID Numbers:
    • Doxycycline effects on TBI
    First Posted:
    Jan 27, 2020
    Last Update Posted:
    Feb 18, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Brain Injuries
    Brain Injuries, Traumatic
    Wounds and Injuries
    Doxycycline

    Study Results

    No Results Posted as of Feb 18, 2021