Traumatic Brain InjuryPhase 4NCT04239755
Doxycycline in Acute Traumatic Brain Injury
A Phase 4 study testing Doxycycline 100 MG Oral Tablet in people with Traumatic Brain Injury, run by Damanhour University at 1 site in Egypt.
Trial summary
evaluate the impact of Doxycycline on both clinical outcome and blood levels of NSE in patients with TBI. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Doxycycline 100 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2020to 30 Oct 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Doxycycline Effects on Neurological Outcomes in Patients With Acute Traumatic Brain Injury
evaluate the impact of Doxycycline on both clinical outcome and blood levels of NSE in patients with TBI.
Read the detailed description
- 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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Doxycycline 100 MG Oral Tablet, placebo
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxycycline 100 MG Oral TabletDrug
Also called vibramycine
doxycycline 100 mg twice daily, either orally or through a nasogastric tube for 5 day
placeboOther
placebo in addition to the standard treatment.
| Study group | Role | What they receive |
|---|---|---|
| Doxycycline | Active comparator | Group (1) 25 patients that receive doxycycline 100 mg twice daily, either orally or through a nasogastric tube for 5 days. Receives: Drug: Doxycycline 100 MG Oral Tablet |
| Placebo | Placebo comparator | group (2) will be 25 patients will receive placebo in addition to the standard treatment. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuron specific enolase
levels of NSE
Measured: 7 days
Glasgow Coma Scale (GCS)
Glasgow Coma Scale (GCS) 15 Points Normal:3 Points Abnormal
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Feb 2020
- Primary completion30 Jul 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Collaborators
- Tanta University
- Responsible party
- Principal investigator, Rehab Werida, Damanhour University
- Investigators
- Noha Mansour, Lecturer, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04239755
- Sponsor's protocol ID
- Doxycycline effects on TBI
- Status last verified
- Feb 2021
- First submitted
- 21 Jan 2020
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11383749Janata 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.
PubMed 31853446
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doxycycline Effects on Neurological Outcomes in Patients With Acute Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT04239755
- Acronym / sponsor ID
- Doxycycline effects on TBI
- Conditions
- Traumatic Brain Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Collaborators
- Tanta University
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
evaluate the impact of Doxycycline on both clinical outcome and blood levels of NSE in patients with TBI.
Detailed description
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doxycycline | Active comparator | Drug: Doxycycline 100 MG Oral TabletGroup (1) 25 patients that receive doxycycline 100 mg twice daily, either orally or through a nasogastric tube for 5 days. |
| Placebo | Placebo comparator | Other: placebogroup (2) will be 25 patients will receive placebo in addition to the standard treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doxycycline 100 MG Oral TabletAlso: vibramycinedoxycycline 100 mg twice daily, either orally or through a nasogastric tube for 5 day | Drug | Doxycycline |
| placeboplacebo in addition to the standard treatment. | Other | Placebo |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Results publication: PubMed 11383749Sanchez 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.
- Results publication: PubMed 31853446Janata 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noha Mansour, Lecturer principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Doxycycline 100 MG Oral Tablet in people with Traumatic Brain Injury, run by Damanhour University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuron specific enolase (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04239755, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.