Abbvie ((ABBV)) announced an update on their ongoing clinical study.
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AbbVie, in collaboration with Pfizer, is conducting a clinical study titled ‘A PHASE 2A, 2-PART, OPEN-LABEL, NON-RANDOMIZED, MULTICENTER, SINGLE AND MULTIPLE DOSE TRIAL TO EVALUATE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF AZTREONAM AND AVIBACTAM ± METRONIDAZOLE IN NEONATES AND INFANTS FROM BIRTH TO LESS THAN 9 MONTHS OF AGE WITH SUSPECTED OR CONFIRMED INFECTIONS DUE TO GRAM-NEGATIVE PATHOGENS REQUIRING INTRAVENOUS ANTIBIOTIC TREATMENT’. The study aims to assess the safety and effects of the antibiotic combination aztreonam-avibactam (ATM-AVI) in treating gram-negative bacterial infections in newborns and infants.
The intervention involves administering ATM-AVI, a combination of an antibiotic and a resistance inhibitor, to combat gram-negative bacterial infections. The study is divided into two parts: Part A involves a single dose, while Part B involves multiple doses to evaluate safety, tolerability, and efficacy.
This interventional study follows a non-randomized, single-group design with no masking. It is structured in two parts, each with four age cohorts, focusing on basic science objectives.
The study began on May 28, 2024, with a primary completion date yet to be announced. The most recent update was submitted on September 2, 2025, indicating ongoing recruitment.
This study could significantly impact AbbVie’s market position by enhancing its portfolio in pediatric infectious disease treatment, potentially boosting investor confidence. The development of effective treatments for gram-negative bacterial infections could also influence the competitive landscape, with other pharmaceutical companies closely monitoring these advancements.
The study is currently recruiting, and further details are available on the ClinicalTrials portal.