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Important Safety Information Full Prescribing Information
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Cellulitis: physician submitted case

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Lisa F, New York

Avid hiker with cellulitis

"I chose ORBACTIV® as an initial treatment because it is a single dose antibiotic and could potentially avoid a lengthy hospital stay for Lisa. In my experience with ORBACTIV®, Lisa is a good candidate for this drug and consequently responded to the treatment."

—Dr. David Davidson

Background

  • Lisa is a 58-year old avid hiker and an insulin dependent diabetic. She developed a blister on her foot during a hike, which burst and got infected. She was seen by her primary care physician 7 days later and was immediately referred to Dr. Davidson.

Presentation

  • Lisa presented on an emergency basis from her primary care physician with a very acute soft tissue infection without any drainage of her foot. Her foot was markedly swollen, with an open wound on the top of the fourth toe. She was diagnosed with cellulitis.

Evaluation

  • BP: 126/81 mmHG
  • Pulse: 101/min
  • BMI: 32.4 kg/m2
  • Glucose: 450 mg/dL
  • Temp: 101ºF
  • WBC: 14,300/mcL
  • ESR: 93mm/hr
  • CRP: 16.4mg/dL
  • HgA1C: 11.5%

Watch what Lisa and Dr. Davidson have to say about the infection and its resolution with ORBACTIV®

Resolution of Lisa’s cellulitis following administration of single dose ORBACTIV® on 05.12.2017

05.11.2017

05.15.2017

05.18.2017

05.25.2017

06.08.2017

06.22.2017

07.10.2017

08.02.2017

The treating physician is a paid consultant of Melinta Therapeutics, Inc. This case study is an actual patient who was treated with a single 1200mg dose of ORBACTIV®. No additional treatments were given to the patient for this infection. Results presented are consistent with results observed in the SOLO trials of patients with ABSSSI. In the SOLO I and SOLO II trials the clinical response rates at 14-24 days for patients receiving ORBACTIV® were 79.6% and 82.7% respectively. Click here to see clinical study results from the SOLO trials. Individual results may vary.

Download a PDF of this case study here.

Background

  • Lisa is a 58-year old avid hiker and non-insulin dependent diabetic. She developed a blister on her foot during a hike, which burst and got infected. She was seen by her primary care physician 7 days later and was immediately referred to Dr. Davidson.

Presentation

  • Lisa presented on an emergency basis from her primary care physician with a very acute soft tissue infection without any drainage of her foot. Her foot was markedly swollen, with an open wound on the top of the fourth toe. She was diagnosed with cellulitis.

Evaluation

  • BP: 126/81 mmHG
  • Pulse: 101/min
  • BMI: 32.4 kg/m2
  • Glucose: 450 mg/dL
  • Temp: 101ºF
  • WBC: 14,300/mcL
  • ESR: 93mm/hr
  • CRP: 16.4mg/dL
  • HgA1C: 11.5%

More patient stories

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14-24 days

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At presentation

14-24 days

Cellulitis

44-year old male with renal insufficiency

At presentation

14-24 days

Abscess

24-year old otherwise healthy male

INDICATION AND USAGE

ORBACTIV® (oritavancin) for injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused or suspected to be caused by susceptible isolates of the following gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible [MSSA] and -resistant [MRSA] isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), and Enterococcus faecalis (vancomycin-susceptible isolates only).

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ORBACTIV® and other antibacterial drugs, ORBACTIV® should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

 Important Safety Information

Contraindications

Use of intravenous unfractionated heparin sodium is contraindicated for 120 hours (5 days) after ORBACTIV® administration because the activated partial thromboplastin time (aPTT) test results may remain falsely elevated for approximately 120 hours (5 days) after ORBACTIV® administration.

ORBACTIV® is contraindicated in patients with known hypersensitivity to oritavancin products.

Warnings and Precautions

Coagulation test interference: Oritavancin has been shown to artificially prolong aPTT for up to 120 hours and may prolong PT and INR for up to 12 hours, and ACT for up to 24 hours. Oritavancin has also been shown to elevate D-dimer concentrations up to 72 hours. For patients who require aPTT monitoring within 120 hours of oritavancin dosing, consider a non-phospholipid dependent coagulation test such as a Factor Xa (chromogenic) assay or an alternative anticoagulant not requiring aPTT.

Serious hypersensitivity reactions, including anaphylaxis, have been reported with the use of oritavancin products, including ORBACTIV®. Discontinue infusion if signs of acute hypersensitivity occur. Closely monitor patients with known hypersensitivity to glycopeptides.

Infusion Related Reactions: Administer ORBACTIV® over 3 hours to minimize infusion-related reactions. Infusion reactions characterized by chest pain, back pain, chills and tremor have been observed with the use of oritavancin products (e.g. ORBACTIV®), including after the administration of more than one dose of oritavancin during a single course of therapy. Stopping or slowing the infusion may result in cessation of these reactions.

Clostridioides difficile-associated diarrhea: Evaluate patients if diarrhea occurs.

Concomitant warfarin use: Oritavancin has been shown to artificially prolong PT/INR for up to 12 hours. Patients should be monitored for bleeding if concomitantly receiving ORBACTIV® and warfarin.

Osteomyelitis: Institute appropriate alternate antibacterial therapy in patients with confirmed or suspected osteomyelitis.

Prescribing ORBACTIV® in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of development of drug-resistant bacteria.

Adverse Reactions

The most common adverse reactions (≥3%) in patients treated with ORBACTIV® were headache, nausea, vomiting, limb and subcutaneous abscesses, and diarrhea.

Please see Full Prescribing Information for ORBACTIV®.

INDICATION AND USAGE

ORBACTIV® (oritavancin) for injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused or suspected to be caused by susceptible isolates of the following gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible [MSSA] and -resistant [MRSA] isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), and Enterococcus faecalis (vancomycin-susceptible isolates only).

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ORBACTIV® and other antibacterial drugs, ORBACTIV® should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.