Subject: In-Practice Usage and Performance (IPUP) Study of Mox-CV 625mg tablets/ BD distab or syrup/ DS distab or syrup;
Study code: IPUP/Mox-CV /Maxxim /May’23

Upper airway infections in children and adults 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.

Mox-CV 625 tablets (Amoxicillin 500 mg and clavulanic acid 125 mg) tablets, Mox-CV BD (Amoxicillin 200mg + Clavulanic acid 28.5mg) available in two formulations (Syrup and Distab) and Mox-CV DS (Amoxicillin 400mg + Clavulanic acid 57mg) available in two formulations (Syrup and Distab) are marketed by the ‘Maxxim ’ 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. This rettrospective study will help to assess the real-life performance of Mox-CV in patients with respiratory tract infection, dental infections and skin and skin structure infections.

We invite you to participate in this study. All you need to do is to report on a standard form your experience with Mox-CV in 10 consecutive number of patients (to avoid any bias) in whom you prescribe this product in the normal course of your practice. Thus, this is not an experimental / interventional 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 ‘Mox-CV 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. {{$contractAmount}}/-, and accordingly on receiving the completed CRFs.