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Completed

NCT Number: NCT04239755

Doxycycline in Acute Traumatic Brain Injury

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

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tanta University Hospital

Tanta, El-Gharbia, 31527, Egypt

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doxycycline 100 MG Oral Tablet

Drug

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

Other names: vibramycine

Placebo

Other

placebo in addition to the standard treatment.

Primary outcomes

  1. Neuron specific enolase

    Time frame: 7 days

    levels of NSE

  2. Glasgow Coma Scale (GCS)

    Time frame: 7 days

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

Sponsors and collaborators

Lead sponsor

Damanhour University

Other

Collaborators

  • Tanta University

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 27, 2020
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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