Clinical Outcomes and Real-World Effectiveness of Amoxicillin-Clavulanic Acid Across Indian Healthcare Settings: A Retrospective Multicenter Study

TL;DR

This study evaluates how well amoxicillin-clavulanic acid works in real-world Indian healthcare settings for various infections.

Contribution

The study provides real-world data on the effectiveness and safety of amoxicillin-clavulanic acid across diverse Indian healthcare settings.

Findings

Clinical resolution was achieved in 82.5% of patients prescribed amoxicillin-clavulanic acid.

Adverse drug reactions occurred in 21.6% of cases, primarily mild gastrointestinal symptoms.

The antibiotic was most commonly prescribed for upper respiratory tract infections and showed effectiveness in respiratory and dental infections.

Abstract

Background

Amoxicillin-clavulanic acid is one of the most prescribed antimicrobial combinations in India. However, data on its real-world prescribing trends, effectiveness, and safety remain limited.

Objective

To evaluate prescribing patterns, dosing practices, adjuvant use, clinical effectiveness, and adverse drug reactions (ADRs) associated with Amoxicillin-clavulanic acid across Indian healthcare settings.

Methods

A retrospective, questionnaire-based multicentric study was conducted using anonymized data from 30,654 patients prescribed Amoxicillin-clavulanic acid under protocol IND/ACL/01. Parameters assessed included demographics, indications, prescriber specialty, dose, duration, adjuvant use, and outcomes. Descriptive statistics were applied.

Results

Among the analyzed prescriptions, upper respiratory tract infections (52.4%) and lower respiratory tract infections (19.5%) were the most common indications, followed by urinary tract infections (10.0%), Helicobacter pylori (H. pylori)-associated gastritis (6.8%), skin and soft tissue infections (5.0%), and dental infections (3.0%). Clinical resolution was achieved in 82.5% of patients, with effectiveness particularly notable in respiratory and dental infections. Adverse drug reactions, mostly mild gastrointestinal symptoms such as diarrhea and nausea, were reported in 21.6% of cases. Treatment duration averaged 7.5±2.8 days, with shorter courses showing similar clinical success. The most common regimen was amoxicillin-clavulanic acid 500/125 mg twice daily for seven to 10 days. Proton pump inhibitors (PPIs) were co-prescribed in 53.9% of cases, mainly rabeprazole, along with probiotics (23.3%).

Conclusions

Amoxicillin-clavulanic acid demonstrated high clinical effectiveness across common indications such as respiratory tract infections, urinary tract infections, skin and soft tissue infections, as well as in dental infections and H. pylori-associated gastritis. Clinical resolution was achieved in over 80% of cases, with a favorable safety profile characterized mainly by mild gastrointestinal adverse events in about 20% of patients. These real-world results underscore its valuable role in diverse Indian healthcare settings, supporting evidence-based prescribing for optimized outcomes.

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