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Doxycycline in Acute Traumatic Brain Injury

Primary Purpose

Traumatic Brain Injury

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Doxycycline 100 MG Oral Tablet
placebo
Sponsored by
Damanhour University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tanta University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Doxycycline

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Neuron specific enolase
levels of NSE
Glasgow Coma Scale (GCS)
Glasgow Coma Scale (GCS) 15 Points Normal:3 Points Abnormal

Secondary Outcome Measures

Full Information

First Posted
January 21, 2020
Last Updated
February 16, 2021
Sponsor
Damanhour University
Collaborators
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT04239755
Brief Title
Doxycycline in Acute Traumatic Brain Injury
Official Title
Doxycycline Effects on Neurological Outcomes in Patients With Acute Traumatic Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
July 30, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Damanhour University
Collaborators
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
evaluate the impact of Doxycycline on both clinical outcome and blood levels of NSE in patients with TBI.
Detailed Description
Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damnhour University. 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. Patients with moderate to severe TBI will be enrolled from Tanta university hospitals. Serum samples will be collected for measuring the biomarkers. Our design is randomized, controlled study. 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. All patients will be followed up during ICU period. Statsicial tests appropriate to the study design will be conducted to evaluate the significance of the results. Measuring outcome: the primary outcome is the change in the serum level of acute brain injury biomarkers. Results, conclusions, discussion and recommendations will be given.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Doxycycline
Arm Type
Active Comparator
Arm Description
Group (1) 25 patients that receive doxycycline 100 mg twice daily, either orally or through a nasogastric tube for 5 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
group (2) will be 25 patients will receive placebo in addition to the standard treatment.
Intervention Type
Drug
Intervention Name(s)
Doxycycline 100 MG Oral Tablet
Other Intervention Name(s)
vibramycine
Intervention Description
doxycycline 100 mg twice daily, either orally or through a nasogastric tube for 5 day
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
placebo in addition to the standard treatment.
Primary Outcome Measure Information:
Title
Neuron specific enolase
Description
levels of NSE
Time Frame
7 days
Title
Glasgow Coma Scale (GCS)
Description
Glasgow Coma Scale (GCS) 15 Points Normal:3 Points Abnormal
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hospital admission in the first 24 h of injury, 18 to 90 years of age and Both sexes with moderate to severe traumatic brain injury (GCS score ≤ 12). Able to tolerate enteral feeding and drug administration within the first 24 hours of TBI Exclusion Criteria: Hypersensitivity to tetracyclines Pregnant and breast feeding women, History of autoimmune disease. History of receiving chronic steroid treatment and isotretinoin, 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), Known malignancies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noha Mansour, Lecturer
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tanta University Hospital
City
Tanta
State/Province
El-Gharbia
ZIP/Postal Code
31527
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11383749
Citation
Sanchez Mejia RO, Ona VO, Li M, Friedlander RM. Minocycline reduces traumatic brain injury-mediated caspase-1 activation, tissue damage, and neurological dysfunction. Neurosurgery. 2001 Jun;48(6):1393-9; discussion 1399-401. doi: 10.1097/00006123-200106000-00051.
Results Reference
result
PubMed Identifier
31853446
Citation
Janata A, Magnet IA, Schreiber KL, Wilson CD, Stezoski JP, Janesko-Feldman K, Kochanek PM, Drabek T. Minocycline fails to improve neurologic and histologic outcome after ventricular fibrillation cardiac arrest in rats. World J Crit Care Med. 2019 Nov 19;8(7):106-119. doi: 10.5492/wjccm.v8.i7.106. eCollection 2019 Nov 19.
Results Reference
result

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Doxycycline in Acute Traumatic Brain Injury

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