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Clinical Trials/NCT04239755
NCT04239755CompletedPhase 4

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

Damanhour University1 site in 1 country50 target enrollmentStarted: February 1, 2020Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
Neuron specific enolase
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Doxycycline

Active Comparator

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

Intervention: Doxycycline 100 MG Oral Tablet (Drug)

Placebo

Placebo Comparator

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

Intervention: placebo (Other)

Outcomes

Primary Outcomes

Neuron specific enolase

Time Frame: 7 days

levels of NSE

Glasgow Coma Scale (GCS)

Time Frame: 7 days

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rehab Werida

Clinical Pharmacy Lecturer

Damanhour University

Study Sites (1)

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Doxycycline in Acute Traumatic Brain Injury | Clinical Trial