Minocycline for High Blood Pressure

Recruiting at 1 trial location

Overseen By Sarah Long, RN

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Florida

Must be taking: Thiazide diuretics

Must not be taking: Oral antibiotics

Disqualifiers: Secondary hypertension, Myocardial infarction, others

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: 5

Duration: 12 weeks

120 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it requires that you have been on a stable blood pressure medication regimen for at least 30 days before joining. You should discuss your specific medications with the trial team.

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}

What is the purpose of this trial?

The goal of this clinical trial is to learn about the mechanisms by which minocycline effect blood pressure in individuals with treatment-resistant hypertension. The main questions it aims to answer are: * To what extent does minocycline lower blood pressure and are these effects different across races? * Are such blood pressure effects mediated through changes in gut microbiota, gut leakiness, systemic inflammation, neuroinflammation, or some combination of these? Participants will be randomly assigned to treatment with minocycline or placebo, treated daily for 3 months, to evaluate these questions.

Research Team

Steven M Smith, PharmD, MPH

Principal Investigator

University of Florida

Eligibility Criteria

This trial is for individuals with high blood pressure that doesn't get better with treatment. Participants will be studied to see how minocycline affects their condition, considering factors like race and changes in gut health.

Inclusion Criteria

My high blood pressure is not controlled despite taking three or more blood pressure medications.

Self-identify as White or African American

The participant agrees to have all study procedures performed

Exclusion Criteria

Current pregnancy or anticipated pregnancy during the study

Evidence of alcoholism or drug abuse

Known hypersensitivity or contraindication to minocycline or other tetracyclines

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants are randomly assigned to receive either minocycline or placebo, administered twice daily for 3 months

12 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including blood tests and neuroimaging for those in the substudy

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Minocycline

Trial Overview The study tests if minocycline can lower blood pressure in resistant cases over a 3-month period, compared to a placebo. It also explores whether the effects are due to changes in gut bacteria, inflammation or other factors.

Participant Groups

Group I: Minocycline Hydrochloride Experimental Treatment 1 Intervention

Minocycline hydrochloride 100 mg, administered twice daily for 3 months

Group II: Placebo Placebo Group 1 Intervention

Placebo administered twice daily for 3 months

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+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Findings from Research

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]

References

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]