Minocycline for High Blood Pressure

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Steven M Smith, PharmD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: University of Florida

Must be taking: Thiazide diuretics

Must not be taking: Oral antibiotics

Disqualifiers: Secondary hypertension, Myocardial infarction, others

Prior Safety Data

Approved in 7 Jurisdictions

Trial Summary

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.

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.

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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

Trial 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)

Participant Groups

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.

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, United States, United States 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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

UF Health Cardiology - Heart & Vascular Hospital Gainesville, FL

UF Health Cardiovascular Clinic Gainesville, FL

Who Is Running the Clinical Trial?

University of Florida Lead Sponsor

National Heart, Lung, and Blood Institute (NHLBI) Collaborator

Emory University Collaborator

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] Between February 1994 and November 1998, 56 oncology patients infected with vancomycin-resistant enterococci (VRE) were treated with quinopristin-dalfopristin (Q-D) plus minocycline (MIN). Infections included bacteremia, urinary tract infection, pneumonia, and wound infection. The response rate was 68%, and the most frequent adverse event was arthralgia or myalgia (36%). Q-D-MIN is effective for VRE infection in cancer patients but is associated with a substantial frequency of arthralgia or myalgia.

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] Staphylococcus aureus strains resistant to a variety of antimicrobial agents are often found in the hospital environment and are responsible for many life-threatening infections. The activity of quinupristin/dalfopristin against 84 Staphylococcus aureus bloodstream isolates (both methicillin resistant and methicillin sensitive) was compared to the activity of vancomycin, teicoplanin, erythromycin, oxacillin, clindamycin, gentamicin, rifampicin. The Minimum Inhibitory Concentrations of these agents was evaluated with the Epsilometer Test. Quinupristin/dalfopristin inhibited all methicillin-sensitive strains at 1mg/L, and 75% of methicillin-resistant strains at 1.5mg/L. According to these results, quinupristin-dalfopristin shows promising in-vitro activity and may be a welcome alternative treatment for methicillin-resistant staphylococcal infections, resulting in reduced use of glycopeptides.

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] Afabicin (formerly Debio 1450, AFN-1720) is a prodrug of afabicin desphosphono, an enoyl-acyl carrier protein reductase (FabI) inhibitor, and is a first-in-class antibiotic with a novel mode of action to specifically target fatty acid synthesis in Staphylococcus spp. The efficacy, safety, and tolerability of afabicin were compared with those of vancomycin/linezolid in the treatment of acute bacterial skin and skin structure infections (ABSSSI) due to staphylococci in this multicenter, parallel-group, double-blind, and double-dummy phase 2 study. Randomized patients (1:1:1) received either low-dose (LD) afabicin (intravenous [i.v.] 80 mg, followed by oral 120 mg, twice a day [BID]), high-dose (HD) afabicin (i.v. 160 mg, followed by oral 240 mg, BID), or vancomycin/linezolid (i.v. vancomycin 1 g or 15 mg/kg, followed by oral linezolid 600 mg, BID). The most frequent baseline pathogen was Staphylococcus aureus (97.5% of microbiological intent-to-treat [mITT] population), and 50.4% of patients had methicillin-resistant S. aureus Clinical response rates at 48 to 72 h postrandomization in the mITT population were comparable among treatment groups (94.6%, 90.1%, and 91.1%, respectively). Both LD and HD afabicin were noninferior to vancomycin/linezolid (differences, -3.5% [95% confidence interval {CI}, -10.8%, 3.9%] and 1.0% [95% CI, -7.3%, 9.2%], respectively). Most common treatment-emergent adverse events were mild and were headache (9.1% and 16.8%) and nausea (6.4% and 8.4%) with LD and HD afabicin, respectively. Afabicin was efficacious and well tolerated in the treatment of ABSSSI due to staphylococci, and these data support further development of afabicin for the treatment of ABSSSI and potentially other types of staphylococcal infections. (This study has been registered at ClinicalTrials.gov under identifier NCT02426918.).

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

Topical treatment of canine and feline pyoderma. [2021] Abstract This paper is a review of commonly used topical antibacterial medications: benzoyl peroxide, chlorhexidine, povidone iodine, ethyl lactate, triclosan, mupirocin, neomycin, polymyxin B, bacitracin and fusidic acid. Included is a review of the pharmacokinetics, modes of action, adverse effects and clinical uses in veterinary dermatology. General recommendations for topical antibacterial therapy are presented. Résumé- Cet article est une revue des topiques antibactériens les plus couramment utilisés: peroxyde de benzoyle, chlorhexidine, povidone iodée, lactate d'éthyle, triclosan, mupirocine, néomycine, polymyxine B, bacitracine et acide fucidique. Il inclut notamment une revue des pharmacocinétiques, des modes d'action, des effets secondaires et des indications thérapeutiques de ces produits en dermatologie vétérinaire. Les indications générales du traitement topique antibactérien sont présentées. [Guaguere, E. Topical treatment of canine and feline pyoderma. (Traitement topique des pyodermites canines et félines). Veterinary Dermatology 1996; 7: 145-151.] Resumen Este articulo es una revisión de los productos tópicos antibacterianos más frecuentemente utilizados: peróxido de benzoilo, clorhexidina, povidona yodada, etillactato, triclosan, mupirocina, neomicina, polimixina B, bacitracina y ácido fusidico. Se incluye una revisión de la farmacocinética, mecanismos de acción, efectos colaterales y sus usos clínicos en dermatologia veterinaria. Se presentan recomendaciones generales para la terapia antibacteriana tópica. [Guaguere, E. Topical treatment of canine and feline pyoderma. (Tratamiento topico de la pioderma canina y felina). Veterinary Dermatology 1996; 7: 145-151.] Zusammenfassung- Diese Veröffentlichung besteht in einer Übersicht von häufig verwendeten topischen antibakteriellen Arzneimitteln: Benzoylperoxid, Chlorhexidin, Povidon-Jod, Ethyllaktat, Triklosan, Mupirocin, Neomycin, Polymyxin B, Bacitracin und Fusidinsäure. Mit eingeschlossen ist eine Übersicht über Pharmakokinetik, Wirkungsweise, Nebenwirkungen und klinische Anwendung in der Veterinärdermatologie. Allgemeine Empfehlungen für die lokale antibakterielle Therapie werden dargestellt. [Guaguere, E. Topical treatment of canine and feline pyoderma (Lokale Behandlung von kaninen und felinen Pyodermien). Veterinary Dermatology 1996; 7: 145-151.].

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

Dalbavancin for the treatment of paediatric infectious diseases. [2018] To review the topics of interest related to the use of dalbavancin in paediatric patients. PubMed was used to search for all of the studies published over the last 15 years using the key word "dalbavancin". A total of 36 manuscripts were selected, and due to the limited pediatric experience a further research was performed in order to identify clinical trials ongoing. Three studies that concerned children were found in clinicaltrials.gov. This review considers also the manuscripts published on the adult population in order to highlight the gaps requiring further research at pediatric age. Dalbavancin has emerged as a promising agent against resistant Gram-positive invasive infections. It is approved in the United States and Europe for the treatment of adult patients with acute bacterial skin and skin structure infections (SSTIs). Compared to other available antibiotics that are active against multi-resistant bacteria, the advantages of dalbavancin include a lower potential for drug interactions and the possibility of fewer required doses due to a longer half-life. Pharmacokinetic characteristics of dalbavacin are attractive for its clinical impact, especially for children who may avoid prolonged hospitalization and central venous access. However, further studies are needed to establish its appropriate paediatric dosage before it can be licensed for use in newborns and children. For younger patients, at a time when infections due to multidrug-resistant Gram-positive pathogens are increasing, dosage, efficacy and safety data for dalbavancin are needed to ensure the highest antimicrobial efficacy while also minimizing the risk of adverse events.