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Trials test monoclonal antibodies as preventive treatments for bacterial infections
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The NIH recently announced that hospitals in the United States have started recruiting patients in a pair of international phase 2 trials that will examine whether two investigational monoclonal antibodies can prevent common bacterial infections.
The trials — EVADE and SAATELLITE — will enroll ICU patients on mechanical ventilation who are colonized with either Pseudomonas aeruginosa or Staphylococcus aureus. Last year, WHO included both of these bacteria on its first-ever list of antibiotic-resistant “priority pathogens” that pose the greatest threat to human health. The list is intended to promote research and development of new treatments.
“It is becoming increasingly common for hospitalized patients — especially those with weakened immune systems — to develop severe, hard-to-treat bacterial infections,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said in a press release. “These clinical trials testing monoclonal antibodies as novel preventive therapies are part of a global collaborative effort to explore innovative ways to mitigate the threat of antimicrobial resistance.”
In the EVADE trial, researchers will investigate the safety and efficacy of MEDI3902 (MedImmune) against P. aeruginosa. They will randomly assign 286 participants to receive IV MEDI3902 or placebo. The patients will be assessed for pneumonia for 21 days and monitored for 49 days total, according to the release. The study is expected to conclude in February 2021.
The SAATELLITE trial will examine the impact of another treatment known as suvratoxumab, previously MEDI4839 (MedImmune), against S. aureus. Approximately 285 participants will be randomly assigned to receive IV suvratoxumab or placebo. They will be evaluated for S. aureus-related illness for 30 days and monitored for 190 days total. The conclusion of this study is slated for June 2019.
Both trials are sponsored by MedImmune and receive support from the Brussels-based Innovative Medicines Initiative Joint Undertaking, the Combatting Antimicrobial Resistance in Europe consortium and the Antibacterial Resistance Leadership Group. The studies will be conducted at sites in the U.S., Austria, Belgium, Croatia, the Czech Republic, France, Germany, Greece, Hungary, Ireland, Israel, Portugal, Spain, Switzerland, Turkey and the United Kingdom. In the U.S., investigators plan to enroll 30 adult patients from 15 ICUs. Thomas L. Holland, MD, infectious disease specialist at Duke University Medical Center, is the coordinating physician for study sites in the U.S.
“S. aureus and P. aeruginosa are two of the most common antibiotic-resistant bacteria that we encounter in clinical practice. Using monoclonal antibodies for the purpose of preventing these infections from developing in the first place — especially among high-risk, critically ill patients — is an innovative approach,” Holland told Infectious Disease News. “This international collaboration will enable us to evaluate whether these two antibodies are effective tools to add to the fight against antibiotic resistance.” – by Stephanie Viguers
References:
NIH. Study of the efficacy and safety of MEDI4893 (SAATELLITE). https://clinicaltrials.gov/ct2/show/study/NCT02296320?term=MEDI4893&rank=1&show_locs=Y#locn. Accessed February 27, 2018.
NIH. Effort to prevent nosocomial pneumonia caused by Pseudomonas aeruginosa in mechanically ventilated subjects (EVADE). https://clinicaltrials.gov/ct2/show/study/NCT02696902?term=MEDI3902&rank=2&show_locs=Y#locn. Accessed February 27, 2018.
Disclosures: Fauci reports no relevant financial disclosures. Infectious Disease News was unable to confirm Holland’s relevant financial disclosures at the time of publication.