CDSCO Panel Approves Pfizer's Protocol Amendment Proposal to Study Aztreonam and Avibactam
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the protocol amendment proposal presented by the drug major Pfizer to study Aztreonam and Avibactam compared to the best available therapy for serious gram-negative infections.
This came after the firm presented protocol amendment 3 dated 10 June 2024 protocol No. C3601008. The purpose of this study is to evaluate how Aztreonam (ATM) and Avibactam (AVI) are processed in pediatric participants. This study also aims to understand participant safety and effects in pediatric participants.
Aztreonam is the first member of a new class of beta-lactam antibiotics, the monobactams. Azitreonam is selectively active against Gram-negative aerobic bacteria and inactive against Gram-positive bacteria.
The bactericidal action of aztreonam results from the inhibition of bacterial cell wall synthesis due to a high affinity of aztreonam for penicillin binding protein 3 (PBP3). By binding to PBP3, aztreonam inhibits the third and last stage of bacterial cell wall synthesis.
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