Cheng, Karen
Newell, Paul
Chow, Joseph W.
Broadhurst, Helen
Wilson, David
Yates, Katrina
Wardman, Angela
Funding for this research was provided by:
Pfizer
AstraZeneca
Novexel
Article History
First Online: 29 June 2020
Compliance with Ethical Standards
:
: The studies NXL104-2001 and NXL104-2002 were sponsored by Novexel, and rights were subsequently acquired by AstraZeneca; RECLAIM 1 and 2 (NCT01499290); RECLAIM 3 (NCT01726023); REPRISE (NCT01644643); RECAPTURE 1 and 2 (NCT01595438 and NCT01599806); and REPROVE (NCT01808092) were originally sponsored by AstraZeneca and are now sponsored by Pfizer. AstraZeneca’s rights to ceftazidime–avibactam were acquired by Pfizer in December 2016. Medical writing support was provided by Jennifer Shepherd, PhD, Mark Waterlow BSc, ISMPP CMPP, and Valerie Moss, PhD, ISMPP CMPP, of Prime, Knutsford, Cheshire and was funded by AstraZeneca and Pfizer. Ultimate responsibility for opinions, conclusions and data interpretation lies with the authors.
: All authors except K.Y. were employees of AstraZeneca at the time of the completion of the ceftazidime–avibactam phase III studies and/or during preparation of the manuscript. P.N., J.W.C., H.B., D.W. and A.W. are current or were shareholders in AstraZeneca during the conduct of the ceftazidime–avibactam phase III studies and/or during preparation of the manuscript. K.Y. was a contractor to AstraZeneca at the time of the studies and during manuscript development. K.C. and J.W.C. are currently employees of Pfizer.
: All studies were conducted in compliance with the Declaration of Helsinki and/or the International Conference on Harmonization Good Clinical Practice Guidelines. All study protocols (NXL104-2001, NXL104-2002, NCT01499290, NCT01726023, NCT01644643, NCT01595438, NCT01599806 and NCT01808092) were approved by relevant Institutional Review Boards and/or Independent Ethics Committees. All patients (or their representatives) provided written informed consent.
: Upon request, and subject to certain criteria, conditions and exceptions (see ExternalRef removed for more information), Pfizer will provide access to individual de-identified participant data from Pfizer-sponsored global interventional clinical studies conducted for medicines, vaccines and medical devices (1) for indications that have been approved in the US and/or EU or (2) in programmes that have been terminated (i.e., development for all indications has been discontinued). Pfizer will also consider requests for the protocol, data dictionary, and statistical analysis plan. Data may be requested from Pfizer trials 24 months after study completion. The de-identified participant data will be made available to researchers whose proposals meet the research criteria and other conditions, and for which an exception does not apply, via a secure portal. To gain access, data requestors must enter into a data access agreement with Pfizer.