The planned multi-center clinical study in India has been initiated and the
first patients recruited at two reputable hospitals. The purpose of the study is
to further validate the efficiency and patient safety of Bactiguard’s Foley
catheters in the prevention of catheter-related urinary tract infections.
Healthcare associated infections are a huge problem worldwide. In India, with
the largest consumption of antibiotics in the world and a high level of multi
-resistant bacteria, healthcare associated infections lead to an even greater
challenge.
– We have great challenges in healthcare associated infections. It is a growing
problem that we seriously need to act against and overcome. We look forward to
implementing the Bactiguard Infection Prevention solution, and to bring down the
number of infections significantly, says Dr. Pankaj R. Shah, Professor & Head,
Department of Nephrology Institute of Kidney Diseases & Research Centre and
Institute of Transplantation Sciences Civil Hospital, Ahmedabad.
The clinical study includes 1 000 patients in total and will be conducted at six
different sites in India, to reflect differences in the population between the
regions. The study was initiated in December 2015 and the results are expected
by the end of 2016. The target groups include patients affected by stroke,
dementia, neuromuscular disease, bladder obstruction, urological surgery or
other elective surgery, where the catheter is expected to be in use for more
than two days.
– The study is an important element in implementing our products at some of the
major hospitals in India. The results and experience from the study will further
strengthen our clinical evidence and will also be a powerful marketing tool in
India, says Cecilia Edström, Director of Sales and New Business.
Bactiguard has already received product approval in India. The aim of this post
-approval study is to further validate the safety and infection prevention
properties of Bactiguard’s technology in the Indian population.
The study has started at two sites in Ahmedabad, one private and one public.
Apollo hospital has a capacity of 350 patients and there, the Bactiguard
catheters will be used throughout the hospital. At Civil Hospital, one of Asia’s
largest public hospitals with a capacity of some 4 000 patients, a specific unit
named the Institute of Kidney Diseases and Research Center will be responsible
for the study. This Institute was founded by Dr H L Trivedi in 1981 and conducts
between 10 and 12 transplantations every day. Some of the doctors at the
Institute have been trained at the Karolinska University Hospital.
In addition to these two sites, trials will be initiated at PGI Chandigarh in
the North of India before the end of the year. At the beginning of next year,
three more sites will be added in the South and East of India.
– The Bactiguard Infection Protection solution has proven its superiority. This
is the first such clinical study in the Indian population and we are excited to
lead the future of infection control measures within the medical device industry
of India, says Dr Bhaumik Mody, CEO of EthiTrials CRO
(Contract Research Organization, Bactiguard’s partner for clinical studies in
India).
For further information, please contact:
Ulrika Berglund, Head of External Affairs, mobile: 46 708 800 407
About Bactiguard
Bactiguard is a Swedish medtech company with a mission of preventing healthcare
associated infections, reducing the use of antibiotics and saving lives by
developing and supplying infection prevention solutions for the healthcare
industry. The company’s patented coating prevents healthcare associated
infections by reducing bacterial adhesion and growth on medical devices.
Bactiguard®-coated urinary catheters are market leading in the US and Japan, and
in recent years the company has developed its own product portfolio of catheters
for the urinary and respiratory tract and the blood stream. Bactiguard is
currently in a strong expansion phase, focused on new markets in the Europe,
Middle East, Asia, Latin America and Southern Africa. The company has market
presence in some 50 countries and has about 60 employees. Its headquarters is
located in Stockholm and production facilities in Sweden and Malaysia.
Bactiguard is listed on Nasdaq Stockholm. Read more about Bactiguard at
www.bactiguard.com
