A landmark study comparing pefloxacin versus traditional combination therapy that changed clinical practice
Every year, millions worldwide are affected by biliary tract infections (BTIs), including conditions like acute cholecystitis (inflamed gallbladder) and cholangitis (infected bile ducts).
In serious cases, BTIs can escalate to life-threatening sepsis if not promptly treated 6 .
For decades, surgeons and infectious disease specialists grappled with a critical question: What is the most effective antibiotic strategy to combat these complex infections while minimizing side effects?
In 1990, a groundbreaking clinical trial directly compared two antibiotic approaches: the newer pefloxacin (a fluoroquinolone) versus the traditional combination of ampicillin plus gentamicin 2 9 . This study not only provided immediate answers but also shaped how we treat biliary infections today.
The biliary system, comprising the gallbladder, bile ducts, and associated structures, serves as the body's drainage pathway for bile—a substance essential for digesting fats.
Normally sterile, this system can become infected when obstructed by gallstones (the most common culprit), tumors, or structural abnormalities 6 .
Biliary infections typically involve bacteria originating from the intestine. The most common offenders include:
Treating BTIs requires a dual approach:
The antibiotic choice presents a dilemma—they must cover likely pathogens while avoiding unnecessary side effects. Historically, clinicians used combination therapy like ampicillin (covering Enterococcus and some Gram-negatives) plus gentamicin (effective against resistant Gram-negatives). However, this approach can potentially damage kidneys 2 .
The 1990 study published in the Journal of Antimicrobial Chemotherapy was a prospective, randomized, open-label trial conducted across multiple centers 2 9 . The researchers employed a robust methodology that remains impressive even by today's standards.
| Outcome Measure | Pefloxacin Group | Combination Therapy Group |
|---|---|---|
| Clinical Cure Rate | 49/50 (98%) | 45/47 (95.7%) |
| Bacteriological Success Rate | 50/50 (100%) | 43/47 (91.5%) |
| Adverse Events | 3/50 (6%) | 6/47 (12.8%) |
The researchers concluded that both regimens provided excellent clinical results for treating biliary tract infections. However, pefloxacin demonstrated several potential advantages:
Single drug versus combination therapy
100% versus 91.5% success
Fewer reported side effects
These findings supported the use of fluoroquinolones like pefloxacin as effective alternatives to traditional combination therapies for biliary infections 2 .
Behind every great medical study lies a carefully selected set of tools and reagents. Here's what made this groundbreaking research possible:
| Reagent/Resource | Function in the Study |
|---|---|
| Pefloxacin | Fluoroquinolone antibiotic tested as monotherapy; inhibits bacterial DNA gyrase |
| Ampicillin | Aminopenicillin antibiotic; inhibits bacterial cell wall synthesis |
| Gentamicin | Aminoglycoside antibiotic; inhibits bacterial protein synthesis |
| Culture Media | Used to isolate and identify causative organisms from bile and blood |
| Antibiotic Susceptibility Testing Materials | Determined resistance patterns of bacterial isolates |
| Randomization Protocol | Ensured unbiased allocation of patients to treatment groups |
Landmark study comparing pefloxacin versus ampicillin+gentamicin demonstrates efficacy of single-drug regimen 2 9
First Tokyo Guidelines published, providing evidence-based recommendations for biliary infection management
Updated Tokyo Guidelines refine treatment approaches based on new evidence
Today, guidelines for treating biliary infections have evolved significantly. The Tokyo Guidelines provide evidence-based recommendations :
A growing concern in treating BTIs is antibiotic resistance. Recent studies show concerning trends:
57.23% Enterococcus, 23.41% Staphylococcus 5
Methicillin-resistant Staphylococcus 5
Vancomycin-resistant Enterococcus
For multidrug-resistant infections, researchers are exploring innovative solutions like bacteriophage therapy—using viruses that specifically target bacteria.
A recent case study reported successful use of personalized phage therapy against multidrug-resistant Pseudomonas aeruginosa in a patient with chronic biliary tract infection 3 8 . Though not yet mainstream, this approach offers hope for addressing the antibiotic resistance crisis.
The 1990 prospective randomized comparison of pefloxacin versus ampicillin plus gentamicin represented a significant milestone in biliary infection management.
Though pefloxacin itself is rarely used today (superseded by newer fluoroquinolones), this study's contributions endure:
Demonstrated that single-drug regimens could be as effective as combination therapies
Highlighted the importance of bacteriological eradication alongside clinical cure
Exemplified rigorous methodology in comparing antibiotic strategies
The next time you or a loved one receives antibiotics for a biliary infection, remember that behind today's treatment decisions lies a rich history of medical discovery—including pioneering studies like this 1990 trial that helped shape modern infectious disease management.