Polymyxin-Indian-Consensus Expert Statements Guideline - Medical Writing Support

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- CR-GNB infections especially NDM-1 or NDM-1 plus OXA-48, Escherichia coli, DTR-Pseudomomonas aeruginosa, Acenatobacter baumanii infections, etc. remain endemic in Indian ICUs. - Polymyxin B and Colistin (i.e. Polymyxin E) are last-line, life-saving agent with both having almost similar structural characteristics belonging to the class of Polymyxin Antibiotics, but largely different renal & neurological safety outcomes as well as pharmacokinetics. - Nephrotoxicity & Neurotoxicity are the two major dose-limiting toxicities of both Polymyxin B and Colistin despite high clinical efficacy with reported cases of Hyperpigmentation in some individuals as well, with a relatively unknown mechanism compared to the two Severe Adverse Events (SAEs) which can potentially and mechanistically lead to irreversible end-organ damage like AKI or CKD in a few cases as well as prolonged Hospital or ICU stay, depending on unfavourable patient related factors present at the time of admission or start of Polymyxin therapy. - Despte the discovery of both the drugs around the year 1947, there are many knowledge gaps pertaining to Indian population; ranging from PK studies to RCTs to evaluate their efficacy & toxic AEs or association of newer AEs to population specific dose ranging studies in Sepsis patiients population, which is a special population of interest due to deranged multi-organ function especially in patients presenting with AKI. Why is the Pol-I-Con Expert Statements, the need of the hour: - PK/PD advances and studies which were sparcely studied in restricted populations earlier and which have been recently updated. - Emerging Evidences on upcoming topics like Therapeutic Drug Monitoring (TDM) of Polymyxins. - Scope of Monitoring to eliminate AEs. - Heterogeneous Acute Kidney Injury definitions & monitoring protocols in literature. - Sparse brand-specific pharmacovigilance data. - Need for India-specific pragmatic guidance for critical care physicians and intensivists. - Review renal safety evidence for polymyxin B from available studies needs to be updated. - No head-to-head RCTs comparing generic brands. - Best Antimicrobial Stewardship practices to prevent resistance due to Polymyxins. - Guide safe ICU practice in Indian setting. - Develop consensus amongst 30-35 experts belonging to 6 different specialties from across various geographies of India, using Modified Delphi Technique. Scope of Work: - Literature Review of last 25-30 years and an update to the last published 2019 international consensus guideline on a similar topic. 27 tentative statements are formed for initial review by 6-7 Principal Investigators (PIs) for which we need extensive literature review by the Vendor/Medical Writer from different databases including PubMed, Embase, Google Scholar, Scopus, etc. - After two rounds of Delphi based voting and finalization of the content, the final manuscript draft needs to be prepared by the Medical Writer/Vendor in consultation with us and the PIs. - Timelines: 1. 45 days for Literature Review of 30 years data and formalizing the initial content for each of the 27-30 Consensus Statements. 2. 20 days for post-Delphi finalization of the manuscript to be published. 3. Assistance in publication with a highly rated International Journal like JAK-AMR, Antibiotics, etc. with a quick turnaround time from publication to Online Open Access pre-print available with 100 days of submission.

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Milestones

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You will be asked to answer the following questions when submitting a proposal:

1. What skills you have are most relevant to this job?

2. What is your total years of Medical Writing Experience?

3. Could you provide DOIs or links to at least 3 of your recently published works?

4. Have you collaborated with well-known Pharmaceutical Industry clients in the last 3 years?

5. What is your Academic Qualification and What inspired you to take up Medical Writing as a full-time Job?

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