Minocycline for High Blood Pressure

Overseen By Sarah Long, RN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Florida

Must not be taking: Antibiotics, Anti-inflammatories, Glucocorticoids

Disqualifiers: Pregnancy, Intestinal surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12-24 weeks

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is a mechanistic study that will enroll 9 subjects who are participating in NCT02133872 (which is designed to evaluate minocycline to test the hypothesis that minocycline treatment would produce antihypertensive effects in drug-resistant neurogenic hypertensive individuals) to test whether the antihypertensive effect of minocycline is associated with a decrease in activated microglia in central nervous system autonomic regions as evidenced by changes in PET and MRI imaging.

Do I need to stop taking my current medications for the trial?

Yes, you will need to stop taking certain medications, such as antibiotics, anti-inflammatory agents, and immune-modulating medications, before joining the trial.

Is minocycline safe for use in humans?

In a study involving cancer patients treated with minocycline for infections, the most common side effects were joint pain and muscle pain, affecting 36% of participants. This suggests that while minocycline can be effective, it may cause discomfort in some people. ^{1 2 3 4 5}

Who Is on the Research Team?

Carl Pepine, MD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for individuals with drug-resistant high blood pressure who are already part of another study (NCT02133885). Participants must be willing to travel to Montreal, Canada for brain imaging and testing. They should not be pregnant or have been so in the last 6 months, nor taking certain medications that could affect the study's outcome.

Inclusion Criteria

I am willing to travel to Montreal, Canada for special brain scans and tests.

Subjects participating in IRB approved protocol #102-2013 will be eligible to participate.

Exclusion Criteria

Currently pregnant or have been pregnant in the last 6 months

I have not taken antibiotics in the last 2 months.

Unwilling to discontinue vitamin or supplements, including probiotics, potentially affecting gut microbiota (vitamins/supplements and medications that possibly affect the gut microbiota should be discontinued for at least 2wks prior to stool collection)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Minocycline and undergo baseline and follow-up MRI and PET scans

12-24 weeks

Baseline and follow-up visits for MRI and PET scans

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Minocycline

Trial Overview The trial is studying whether Minocycline can lower blood pressure by reducing microglia activation in the brain. This will be measured using advanced imaging techniques like PET and MRI scans alongside Autonomic Nervous System Testing.

How Is the Trial Designed?

Group I: Minocycline Treatment Group Experimental Treatment 1 Intervention

Participants with neurogenic treatment-resistant hypertension who meet inclusion/exclusion criteria will receive minocycline at a dose determined to be most effective in lowering blood pressure (based on results from Study 1). Participants will undergo brain imaging with MRI and PET at baseline and 26 weeks. Intervention: Drug: Minocycline Dose: 50, 100, or 200 mg/day (based on optimal BP-lowering dose from Study 1) Frequency: Administered orally twice daily (BID) Duration: 26 weeks

Group II: Control Active Control 1 Intervention

Patients without a diagnosis of neurogenic (treatment-resistant) Hypertension and have not been treated with minocycline will be recruited. These participants will undergo one-time brain imaging visit (MRI and PET)

Minocycline is already approved in United States, European Union, Japan, India for the following indications:

Approved in United States as Minocin for:

• Acne
• Bacterial infections
• Periodontal disease
• Rosacea

Approved in European Union as Minostad for:

• Acne

Approved in Japan as Minopen for:

• Bacterial infections

Approved in India as Minoz for:

• Bacterial infections

Approved in United States as Amzeeq for:

• Acne

Approved in United States as Zilxi for:

• Rosacea

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

In a study involving 56 oncology patients with vancomycin-resistant enterococci (VRE) infections, the combination of quinopristin-dalfopristin and minocycline showed a response rate of 68%, indicating its effectiveness against these infections.

The treatment was associated with a notable side effect, with 36% of patients experiencing arthralgia or myalgia, highlighting the need to consider potential adverse effects when using this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of vancomycin-resistant enterococcal infections in the immunocompromised host: quinupristin-dalfopristin in combination with minocycline. Raad, I., Hachem, R., Hanna, H., et al.[2018]

Quinupristin/dalfopristin demonstrated strong in-vitro activity against Staphylococcus aureus, inhibiting all methicillin-sensitive strains at a concentration of 1 mg/L and 75% of methicillin-resistant strains at 1.5 mg/L.

This antibiotic could serve as a promising alternative treatment for methicillin-resistant staphylococcal infections, potentially reducing reliance on glycopeptide antibiotics like vancomycin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative in vitro activity of quinupristin/dalfopristin and seven other antimicrobials against methicillin-susceptible and methicillin-resistant nosocomial Staphylococcus aureus bloodstream isolates. Nikolaidis, P., Metallidis, S., Katikaridou, E., et al.[2013]

Afabicin, a novel antibiotic targeting fatty acid synthesis in Staphylococcus spp., demonstrated comparable efficacy to vancomycin/linezolid in treating acute bacterial skin infections, with clinical response rates of 94.6% for low-dose afabicin and 90.1% for high-dose afabicin.

Both doses of afabicin were well tolerated, with mild side effects like headache and nausea, indicating its potential as a safe treatment option for staphylococcal infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Afabicin, a First-in-Class Antistaphylococcal Antibiotic, in the Treatment of Acute Bacterial Skin and Skin Structure Infections: Clinical Noninferiority to Vancomycin/Linezolid. Wittke, F., Vincent, C., Chen, J., et al.[2022]

The review covers various topical antibacterial medications commonly used in veterinary dermatology, including their pharmacokinetics, mechanisms of action, and potential side effects, providing a comprehensive understanding of their clinical applications.

General recommendations for the use of topical antibacterial therapy in treating conditions like canine and feline pyoderma are presented, emphasizing the importance of selecting the appropriate medication based on specific clinical needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical treatment of canine and feline pyoderma. Guaguere, E.[2021]

Dalbavancin shows promise as an effective treatment for resistant Gram-positive infections in children, with advantages such as fewer doses needed and lower potential for drug interactions, based on a review of 36 studies and ongoing clinical trials.

However, more research is necessary to determine the appropriate dosage and safety of dalbavancin in pediatric patients before it can be widely used in newborns and children, especially given the rise of multidrug-resistant infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dalbavancin for the treatment of paediatric infectious diseases. Esposito, S., Bianchini, S.[2018]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Treatment of vancomycin-resistant enterococcal infections in the immunocompromised host: quinupristin-dalfopristin in combination with minocycline. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Comparative in vitro activity of quinupristin/dalfopristin and seven other antimicrobials against methicillin-susceptible and methicillin-resistant nosocomial Staphylococcus aureus bloodstream isolates. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Afabicin, a First-in-Class Antistaphylococcal Antibiotic, in the Treatment of Acute Bacterial Skin and Skin Structure Infections: Clinical Noninferiority to Vancomycin/Linezolid. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Topical treatment of canine and feline pyoderma. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Dalbavancin for the treatment of paediatric infectious diseases. [2018]