Clinical comparison study of S-649266 on HABP/VABP/HCABP infections

• Research type

  Research Study

• Full title

  A Multicenter, Randomized, Double-blind, Parallel-group Clinical Study of S 649266 Compared with Meropenem for the Treatment of Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia, or Healthcare-associated Bacterial Pneumonia Caused by Gram negative Pathogens

• IRAS ID

  226597

• Contact name

  Simon Whiteley

• Contact email

  Simon.whiteley@nhs.net

• Sponsor organisation

  Shionogi Ltd.

• Eudract number

  2016-003020-23

• Clinicaltrials.gov Identifier

  NCT03032380

• Duration of Study in the UK

  1 years, 4 months, 30 days

• Research summary

  This is an international multicentre trial to compare the effects of a new antibiotic compound (S-649266) with those of a standard antibiotic (meropenem) when used for the treatment of Hospital-acquired bacterial pneumonia (HABP), Ventilator-associated bacterial-pneumonia (VABP), and Health-Care-Associated bacterial pneumonia (HCABN) caused by gram negative bacteria.
  S-649266 is being developed to address the unmet medical need to treat infections caused by carbapenem resistant Gram-negative bacteria including HABP, VABP and HCABP.
  The primary objective of the study is to compare all-cause mortality at day 14 of subjects who receive the study drug with that of those subjects who receive the comparator. Secondary objectives include comparing the clinical outcome of treatment (clinical effectiveness) and microbiological outcome (microbiological effectiveness) of treatment in the two groups.
  300 volunteers, over the age of 18, with lung infections that meet the diagnostic criteria for HABP, VABP and HCABP will be recruited across the (estimated) 145 participating sites. Participants will be randomised to receive the study drug or the comparator drug for a period of 7 - 14 days as required to treat their condition. In exceptional circumstances the duration of the drug administration could be increased to 21 days if the treating doctor considers it necessary to treat the patient’s infection. Both groups will also receive a standard antibiotic (linezolid) for 5 days to eradicate any gram positive infection. Following treatment participants will be followed up for a period of up to 4 weeks during which period they will be asked to attend hospital for follow up blood tests.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  18/YH/0038

• Date of REC Opinion

  22 Mar 2018

• REC opinion

  Further Information Favourable Opinion