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John Parkinson


Although the development of antibiotics overall has its challenges including the lack of new therapies getting approved, Bruce M. Jones, PharmD, FIDSA, BCPS, infectious diseases clinical pharmacy specialist at St. Joseph's/Candler Health System in Savannah, GA, is optimistic about the newer antibiotics when it comes to treatment for skin and soft tissue infections (SSTIs).

Jones says the challenges for him in this treatment space include provider education and resources as well as easier access to patients.

“For me, a lot of what we see with these agents is coming from the outpatient side, whether it is outpatient infusion, specialty pharmacy, so reimbursement and a lot of the financials that come with these, and access to these drugs are definitely issues,” Jones stated. “It’s something that makes them harder to use because now you are talking more about a process than letting me hand you a prescription and you can go down the street and fill it.”

He would like to see more resources and education around these important antibiotics.
   


 is running a short series of video interviews to discuss SSTIs, and Jones sat down in a far-ranging interview to discuss criteria and decisions around whether SSTIs should be treated as inpatient or outpatient, what his institution is experiencing, and his perspective on the currently approved antibiotics.

In this episode, Jones provides his perspective on antibiotics for SSTI treatment, insights on patient profiles and who might be the best candidates for which therapy, and how his institution works to decrease length-of-stays for inpatients as they work to transition patients to outpatient treatment more efficiently. 

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A clinician offers insight into what he sees in terms of these therapies and the need to get more information to those providers in the field as well as access to them. 



Clinician Perspective on the Latest SSTI Antibiotics


The last time the Infectious Diseases Society of America (IDSA) updated its treatment guidelines for skin and soft tissue infections (SSTIs) was back in 2014. In that time there has been the addition of new therapies for these infections, and thus in some instances, leaving outdated guidelines for clinicians.

Bruce M. Jones, PharmD, FIDSA, BCPS, infectious diseases clinical pharmacy specialist at St. Joseph's/Candler Health System in Savannah, GA, says the importance of following the IDSA guidelines combined with the addition of the newer antibiotics can be challenging. In fact, he says clinicians have more novel options for treatment with both oral and IV modalities for SSTIs. “There’s a lot that’s changed and a lot of new agents have come to the market.” 

Jones says you are not going to give every patient with an SSTI one of the newer therapies, but he says it’s about looking at having the criteria of how to pick the right patients to decipher who might be appropriate for which antibiotic.

And in the background is stewardship and how this can be applied with this confluence of therapies and the guidelines.



 is running a short series of video interviews to discuss SSTIs, and Jones sat down in a far-ranging interview to discuss criteria and decisions around whether SSTIs should be treated as inpatient or outpatient, what his institution is experiencing, and his perspective on the therapy pipeline.

In this episode, Jones discusses the evolving treatment landscape for SSTIs, the IDSA guidelines, and the ability to consider stewardship opportunities when treating these patients.

With the proliferation of therapies for skin and soft tissue infections (SSTIs), a clinician discusses how providers can appropriately find the balance between these novel therapies, the existing treatment guidelines, and stewardship. 

The Confluence of New Antibiotics, Treatment Guidelines, and Antimicrobial Stewardship in SSTIs


When patients inform their clinicians that they have a penicillin allergy, frequently no follow-up is done in terms of questioning the severity of it or even the possibility a patient may have outgrown it. It is usually just noted in the patient's medical record.

Bruce M. Jones, PharmD, FIDSA, BCPS, infectious diseases clinical pharmacy specialist at St. Joseph's/Candler Health System in Savannah, GA, says this is a missed opportunity.

“One of the first things I say [to patients with penicillin allergies] is, ‘you are on an antibiotic, and it’s my job to get you on the best antibiotic,’” Jones stated. “And the penicillin allergy is what is preventing that for this patient.”

He performs a significiant amount of research around penicillin allergies, and when appropriate, Jones will consult with inpatients on possibly doing penicillin graded challenges. He tries to provide them with all the information to help them make decisions about their care, especially as it pertains to their antibiotic treatment.

He says that after a consultation, they can remove the patient's penicillin allergy approximately 25% of the time.



 has begun a short series of video interviews to discuss skin and soft tissue infections (SSTIs), and Jones sat down in a far-ranging interview to discuss criteria and decisions around whether SSTIs should be treated as inpatient or outpatient, what his institution is experiencing, and his perspective on the therapy pipeline.

In this episode, Jones discusses the grading process and consulting patients about their allergies.

A clinician has a novel approach to patient conversations around this topic to determine if they want to assess if their penicillin allergies truly present a problem for treatment.   



Broaching the Subject of Antibiotic Allergy Challenges with Patients

Hospital capacity has been an ongoing challenge at many institutions. If you look at the height of the COVID-19 pandemic or currently with RSV cases within pediatric units being overwhelmed, overcrowded hospitals continue to be difficult scenarios and tax both the hospital institutions but also patients as they wait to get admitted and may be in uncomfortable health states.

Whereas some patients absolutely need to be cared for and followed as inpatients, some patients may be able to be treated in outpatient clinics. In recent years, the discussion around skin and soft tissue infections (SSTI) and the ability to treat them in outpatient clinics when appropriate has been one strategy to help with overcapacity.

Bruce M. Jones, PharmD, FIDSA, BCPS, infectious diseases clinical pharmacy specialist at St. Joseph's/Candler Health System in Savannah, GA, says the biggest reason why they are seeing SSTI patients come in is when oral antibiotics are not efficacious, possibly because of a penicillin allergy. In these situations, and when appropriate, Jones will consult with patients on possibly doing penicillin graded challenges. He tries to counsel patients and give them all the information to help them make decisions about their care. 

 is introducing a short series of video interviews to discuss SSTIs, and Jones sat down in a far-ranging interview to discuss criteria and decisions around whether SSTIs should be treated as inpatient or outpatient, what his institution is experiencing, and his perspective on the therapy pipeline.

In this episode, Jones discusses the transitional phase of care, what criteria results are best for inpatient treatment of SSTIs, and consulting patients about their infections.

In episode 1 of this short video series, a clinician discusses what types of patients are best suited for inpatient or outpatient care for these infections.

Considering Criteria for Admission for Skin and Soft Tissue Infections

Transplant patients with pulmonary fungal infections can be especially challenging to treat for a whole host of reasons.

“Treatment options for many transplant patients who experience aspergillus fungal infections are often limited due to multiple pre-existing conditions, including skin cancers and intolerance to prior oral voriconazole therapy,” Gregory Snell, MBBS, MD, medical head of Lung Transplant Service at the Alfred Hospital in Melbourne, Australia, said.

With these underlying treatment challenges, clinicians may have limitations for administering oral voriconazole.

Back in early November, TFF Pharmaceuticals, a clinical-stage biopharmaceutical company that develops and commercializes therapies utilizing its patented TFF technology platform, announced that a second patient has been successfully treated with the company’s TFF VORI, a powder that can be delivered to the lungs, which was done through a compassionate use program.

These patients were treated at the Alfred Hospital. Infectious diseases physician Bradley Gardiner, MBBS, was part of the treatment team and presented data from the first patient successfully treated with the inhaled powder formulation at the Annual International Congress on Lung Transplantation in September.

Gardiner explains this modality helps deliver a greater concentration of therapy and avoids the systemic side effects.

The company’s TFF technology platform allows for the transformation of both existing compounds and new chemical entities into dry powder formulations. This is a particle engineering process designed to generate dry powder particles with advantageous properties for inhalation, as well as parenteral, nasal, oral, topical, and ocular routes of administration. The process can be used to engineer powders for direct delivery to the site of need, circumventing challenges of systemic administration and leading to improved bioavailability, faster onset of action, and improved safety and efficacy.

The second lung transplant patient was successfully treated with TFF VORI. The patient had a history of skin cancers and multiple fungal infections. During the prior treatment for the fungal infections with oral voriconazole and posaconazole, the patient experienced hair loss, fatigue, and an increased QTc interval that required discontinuation of two cardiovascular medications. These are well known side effects associated with the use of oral azole antifungals. After discontinuing a recent course of posaconazole, the patient then experienced progressively increased coughing, shortness of breath, and did not respond to oral antibiotics. The patient was subsequently diagnosed with a pulmonary aspergillus infection and experienced declining lung function. Given the toxicities from prior oral azole antifungal therapy and the preexisting skin cancers, the patient was no longer able to tolerate oral voriconazole or other azole antifungals.

Following initiation of TFF VORI therapy, the patient’s lung function stabilized without additional decreases in Forced Expiratory Volume in one second (FEV1) or FEV1/Forced Vital Capacity (FVC) ratios. Consistent with the first patient who received TFF VORI, no dose modification of tacrolimus was required, which is notable due to the well-known severe drug-drug interactions between tacrolimus and oral voriconazole. The patient was on TFF VORI therapy for six weeks and has returned negative cultures for aspergillus in recent specimens obtained from bronchoscopic evaluation. These results support the potential safety and efficacy advantages of TFF VORI, which the company expects to further demonstrate in its phase 2 study.

“This is now the second case that we’ve successfully administered this novel inhaled formulation of voriconazole to a lung transplant patient who could no longer tolerate oral voriconazole therapy,” Snell said. “I am encouraged by the clinical response in this second patient, and we will conduct additional testing in cases where alternative treatment options may be necessary.”

Gardiner spoke with 

 who provided insights on TFF VORI, and discussed the treatment of one of the aforementioned patients, as well as the potential benefits of having an alternative to oral voriconazole.

Two patients at a hospital in Australia were administered Thin Film Freezing Voriconazole Inhalation Powder (TFF VORI), which showed treatment efficacy for both patients. 

Utilizing a Novel Modality to Treat Pulmonary Fungal Infections in Lung Transplant Patients

Earlier today, Pfizer and Valneva announced its investigational Lyme disease vaccine, VLA15, demonstrated that its antibody levels remained above baseline six months after completion of a three-dose (Month 0-2-6) or a two-dose (Month 0-6) vaccination schedule.

“Lyme disease continues to spread, representing a high unmet medical need that impacts the lives of many in the Northern Hemisphere, and each new report of positive data takes us a step closer to potentially bringing this vaccine to both adults and children who could benefit from it,” Valneva CMO Juan Carlos Jaramillo MD, said in a statement.

Data were collected in 96 healthy adults and 81 pediatric participants (5-17 years of age) for the Month 0-2-6 vaccination schedule and in 84 healthy adults and 78 pediatric participants (5-17 years of age) for the Month 0-6 schedule.

As observed in previous clinical studies with VLA15, antibody levels declined over time in all study groups but remained above baseline, confirming their persistence six months after completion of both vaccination schedules. Overall, antibody levels remained higher with the three-dose vaccination schedule compared to the two-dose schedule. Geometric mean fold rise (GMFRs) compared to baseline were 1.9-fold for Serotype 1 (ST1) to 3.2-fold Serotype 2 (ST2) across all age groups in the Month 0-2-6 vaccination schedule. The highest GMFRs were reported in the 5 to 11 years old age group, with GMFR levels at 2.8-fold (ST1) to 6.6-fold (ST2).

According to the companies, this investigational multivalent protein subunit vaccine uses an established mechanism of action for a Lyme disease vaccine that targets the outer surface protein A (OspA) of 

, the bacteria that cause Lyme disease. OspA is a surface protein expressed by the bacteria when present in a tick. Blocking OspA inhibits the bacterium’s ability to leave the tick and infect humans. The vaccine covers the six most common OspA serotypes expressed by the 

 species that are prevalent in North America and Europe.

“We are pleased with these antibody persistence data that further validate the use of the three-dose vaccination schedule in our ongoing phase 3 study and the acceptable safety and tolerability profiles of our vaccine candidate,” Jaramillo explained.

No vaccine-related serious adverse events and no safety concerns were observed in the six-month observational follow up.

Earlier this year, the companies initiated their phase 3 clinical study, Vaccine Against Lyme for Outdoor Recreationists (VALOR). The trial is looking for up to 6000 participants that are 5 years of age and older. Everyone will receive 3 doses of VLA15 180 µg or saline placebo as a primary vaccination series followed by 1 booster dose of VLA15 or saline placebo (1:1 ratio). Enrollment is ongoing in Europe and the United States and expected to be completed in the second quarter of 2023.

And pending successful completion of the phase 3 studies, Pfizer could potentially submit a Biologics License Application (BLA) to the FDA and Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in 2025.

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The investigational shot from Pfizer and Valneva demonstrated higher antibody levels in the three-dose vaccination schedule versus the two-dose vaccination schedule.

John Parkinson

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