Comparative Effectiveness of Antimicrobial Regimens for Urinary Tract Infections in India: A Systematic Review and Narrative Synthesis of Randomized Controlled Trials.

OBJECTIVE: To evaluate the comparative effectiveness and safety of antimicrobial regimens in urinary tract infections (UTIs) tested in randomized controlled trials conducted in India and to determine whether any clinically coherent quantitative synthesis was justified. METHODS: PubMed, Embase, Scopus, and Cochrane CENTRAL were searched for randomized controlled trials published from January 2010 to June 2025 that evaluated antimicrobial regimens or treatment durations for symptomatic UTIs in India. Two reviewers independently screened records, assessed full texts, extracted study characteristics and outcome-specific denominators, and linked overlapping publications from the same trial. Risk of bias was assessed, and certainty was evaluated using GRADE (PROSPERO: CRD42025635146). RESULTS: Seven unique randomized trials enrolled or randomized 956 participants. Four trials evaluated different oral regimens for uncomplicated lower UTI, two evaluated ceftriaxone-sulbactam-disodium ethylenediaminetetraacetic acid (CSE) in complicated UTI or acute pyelonephritis against different comparators, and one compared 7 versus 14 days of effective non-fluoroquinolone therapy in selected hospitalized adults with acute pyelonephritis. One observational study was excluded, and two publications from the same CSE-1034 versus ceftriaxone trial were linked to avoid duplicate counting. No exact treatment comparison was replicated across independent trials. Risk of bias was high in three trials and raised some concerns in four. Certainty was low or very low for all comparison-specific conclusions. CONCLUSIONS: The Indian evidence base is sparse and clinically heterogeneous. It neither establishes overall superiority of one antimicrobial nor demonstrates equivalence among regimens. Broader recommendations require larger trials.