Dear Dr. {{$doctorName}},
Subject: In-Practice Usage and Performance (IPUP)Study of Cepodem XP,
Study code: IPUP/Cepodem XP//ENT/Pharma care/April 2023
Cefpodoxime is an oral third generation cephalosporin a β-lactam agent with activity
against both gram positive and gram negative bacteria. In difficult respiratory tract
infections (RTIs) like acute maxillary sinusitis, acute exacerbation of chronic bronchitis
and acute community aquired peumonia there is need for fixed dose combination of
cefpodoxime proxetil and clavulanic acid due to various advantages such as reduction in
minimal inhibitory concentration (MIC) values, enhanced efficacy against resistant
pathogens, and decreses chances of develpoment of resistant strains.
Cepodem XP (cefpodoxime proxetil 200 mg and potassium clavulanate 125 mg) tablets, Cepodem (Dry syrup), available in two strengths (Cefpodoxime proxetil 50/100 mg and potassium clavulanate 31.25/62.5 mg) are marketed by the ‘Pharma care’ 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 cross sectional study to assess the real-life performance of ‘Cepodem XP/ tablets and dry syrup’ in patient’s with RTIs.
We invite you to participate in this study. All you need to do is to report on a standard form your experience with ‘Cepodem XP/ tablets and dry syrup’ in your 4 consecutive patient’s (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 patient’s 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).
CRF has to be verified 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 ‘Cepodem XP/ tablets and dry syrup’ 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 patient’s records, we offer to pay you by cheque a professional fee of Rs. {{$contractAmount}}/- 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.
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