Doxycycline in Acute Traumatic Brain Injury

Doxycycline Effects on Neurological Outcomes in Patients With Acute Traumatic Brain Injury

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

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Drug: Doxycycline 100 MG Oral Tablet; Other: placebo

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuron specific enolase	levels of NSE	7 days
Glasgow Coma Scale (GCS)	Glasgow Coma Scale (GCS) 15 Points Normal:3 Points Abnormal	7 days

Collaborators and Investigators

• Sponsor: Damanhour University
• Collaborators: Tanta University
• Investigators: Principal Investigator: Noha Mansour, Lecturer, Mansoura University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): July 30, 2020
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: January 21, 2020
• First Submitted That Met QC Criteria: January 21, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Doxycycline
• Other Study ID Numbers: Doxycycline effects on TBI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No