Doxycycline in Acute Traumatic Brain Injury

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04239755

Enrollment

Registered

2020-01-27

Start date

2020-02-01

Completion date

2020-10-30

Last updated

2021-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Brief summary

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

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.

Interventions

DRUGDoxycycline 100 MG Oral Tablet

doxycycline 100 mg twice daily, either orally or through a nasogastric tube for 5 day

OTHERplacebo

placebo in addition to the standard treatment.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026