Doxycycline in Acute Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04239755
• Other study ID #: Doxycycline effects on TBI
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2020
• Est. completion date: October 30, 2020

Study information

• Verified date: February 2021
• Source: Damanhour University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 30, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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

Other:
• placebo
placebo in addition to the standard treatment.

Locations

Country	Name	City	State
Egypt	Tanta University Hospital	Tanta	El-Gharbia

Sponsors (2)

Lead Sponsor	Collaborator
Damanhour University	Tanta University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuron specific enolase	levels of NSE	7 days
Primary	Glasgow Coma Scale (GCS)	Glasgow Coma Scale (GCS) 15 Points Normal:3 Points Abnormal	7 days