Doxycycline in Acute Traumatic Brain Injury
Doxycycline Effects on Neurological Outcomes in Patients With Acute Traumatic Brain Injury
1 other identifier
interventional
50
1 country
1
Brief Summary
evaluate the impact of Doxycycline on both clinical outcome and blood levels of NSE in patients with TBI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Feb 2020
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2020
CompletedFirst Posted
Study publicly available on registry
January 27, 2020
CompletedStudy Start
First participant enrolled
February 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2020
CompletedFebruary 18, 2021
February 1, 2021
6 months
January 21, 2020
February 16, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Neuron specific enolase
levels of NSE
7 days
Glasgow Coma Scale (GCS)
Glasgow Coma Scale (GCS) 15 Points Normal:3 Points Abnormal
7 days
Study Arms (2)
Doxycycline
ACTIVE COMPARATORGroup (1) 25 patients that receive doxycycline 100 mg twice daily, either orally or through a nasogastric tube for 5 days.
Placebo
PLACEBO COMPARATORgroup (2) will be 25 patients will receive placebo in addition to the standard treatment.
Interventions
doxycycline 100 mg twice daily, either orally or through a nasogastric tube for 5 day
Eligibility Criteria
You may qualify if:
- Hospital admission in the first 24 h of injury,
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Damanhour Universitylead
- Tanta Universitycollaborator
Study Sites (1)
Tanta University Hospital
Tanta, El-Gharbia, 31527, Egypt
Related Publications (2)
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.
PMID: 11383749RESULTJanata 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.
PMID: 31853446RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Noha Mansour, Lecturer
Mansoura University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Pharmacy Lecturer
Study Record Dates
First Submitted
January 21, 2020
First Posted
January 27, 2020
Study Start
February 1, 2020
Primary Completion
July 30, 2020
Study Completion
October 30, 2020
Last Updated
February 18, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share