Subject: In-Practice
Usage and Performance (IPUP) Study of MOXCLAV DS CP;
Study code :
IPUP/MOXCLAV DS CP /Stanlife/Sep 2023.
Upper
airway infections in children are the most common diseases, and also
the most common reasons for seeking medical consult in primary care.
They also constitute the major diagnosis that
requires the use of antibiotics. Also, dental infections and skin
and skin structure infections are common.
Amoxicillin belongs to aminopenicillins, namely semi-synthetic
penicillins, and is one of the most
commonly prescribed broad-spectrum antibiotics. It belongs to
β-lactam antibiotics that exhibit
antibacterial properties. Amoxicillin/clavulanate has been available
for over 20 years, and continues to be
one of the most widely used antibiotics available for clinical use,
particularly in the treatment of
respiratory tract infection, dental infections and skin and skin
structure infections.
MOXCLAV DS
CP (Amoxicillin 400mg + Clavulanic acid 57mg) available as
pre-filled oral suspension
is marketed by the ‘Stanlife’ team of Sun Pharmaceutical Industries
Ltd.
Although
every product is marketed only after regulatory approval, it is
important to know how it
performs in day-to-day practice of individual medical practitioners.
For this purpose, we have planned to
conduct a prospective study to assess the real-life performance &
convenience of MOXCLAV DS CP in
patients with respiratory tract infection.
We invite
you to participate in this study. All you need to do is to report on
a standard form your
experience with MOXCLAV DS CP in these patients (to avoid any bias)
in whom you prescribe this product
in the normal course of your practice. Thus, this is not an
experimental study because the product
will be prescribed and purchased as you and your patients normally
do.
If you
agree to participate, you will need to copy the relevant information
from the suggested number of
patient’s case papers, and investigational reports, if any (which we
call source documents), on to the
standard case report forms (which we call CRF).
A monitor
will assist you in verifying the CRF with the source documents to
ensure that the CRF signed by
you are free from errors or omissions. Let us assure you that the
CRF will not contain the patients’
names, so as to ensure confidentiality.
If any
serious adverse events (AE) occur during ‘MOXCLAV DS CP therapy, you
will be expected to
report them to the monitor or to me immediately on the AE reporting
form.
As you
will be spending some extra time to keep, copy and verify these
patients records, we offer to pay
you by cheque a professional fee of Rs.2,500/- (Two Thousand Five
Hundred) per patient, and accordingly
on receiving the completed CRFs.
We trust
you and we are partners in promoting safe and effective drug
therapy. In that spirit, we hope
you will consent to participate in this study. If you do, please
sign and return the enclosed reply along
with your visiting card for accuracy of records.
|
}}){kind=logo}