View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
April 28, 2021updated 12 Jul 2022 11:18am

NIH announces start of antibiotic trial for S. aureus bacteremia treatment

The National Institutes of Health (NIH) has announced the start of a Phase IIb clinical trial of existing antibiotic dalbavancin for treating complicated Staphylococcus aureus (S. aureus) bacteremia. 

The National Institutes of Health (NIH) has announced the start of a Phase IIb clinical trial of existing antibiotic dalbavancin for treating complicated Staphylococcus aureus (S. aureus) bacteremia.

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

Dalbavancin is approved by the US FDA for treating acute bacterial skin and skin structure infections, including the S. aureus ones.

With a strong activity against gram-positive bacteria, including methicillin-resistant S. aureus, the antibiotic could potentially be an effective treatment for S. aureus bacteremia.

S. aureus bacteremia is an infection of the blood and needs an invasive procedure of inserting a central intravenous (IV) catheter to provide long courses of antibiotics.

Named ‘Dalbavancin as an Option for Treatment of S. aureus Bacteremia (DOTS)’, the trial is sponsored by the NIH unit National Institute of Allergy and Infectious Diseases (NIAID) and carried out by NIAID-funded Antibacterial Resistance Leadership Group (ARLG).

It will enrol 200 adult subjects hospitalised with complicated S. aureus infection at approximately 20 sites in the US.

Individuals who have stabilised after initial treatment of their bacteremia will be eligible to take part in the trial.

The subjects will be randomised to receive the standard of care for complicated infections, including appropriate antibiotics or two intravenous 1500mg dose of dalbavancin given one week apart.

Various patient outcomes such as survival; additional complications (such as relapse) or clinical failures; drug-related adverse events; and overall quality of life will be evaluated at the end of the trial.

NIH noted that the regimen will have met the trial’s primary endpoint if subjects who received dalbavancin fare better on these metrics compared to those who received the current standard of care.

NIAID Director Anthony Fauci said: “As antibiotic-resistant infections become more widespread, better and easier treatment regimens are needed to ease the burden on both healthcare providers and patients.

“By investigating existing antibiotics for their action on a broader array of bacterial infections, we may be able to generate new treatment regimens more efficiently.”

Last week, the NIH announced plans to fund the Phase III ACTIV-6 clinical trial to analyse various prescription and over-the-counter medications that are currently available for self-administration to treat Covid-19 symptoms.

Related Companies

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Clinical Trials Arena