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Multiplex Therapeutic Drug Monitoring by Isotope-dilution HPLC-MS/MS of Antibiotics in Critical Illnesses
Published on: August 30, 2018
The need for controlled clinical studies in antimicrobial therapy
Annals of Internal Medicine
|November 1, 1978
Summary
New antimicrobial treatments show promise in lab studies but lack rigorous clinical trials. More research is needed to prove their effectiveness and safety for chronic infections.
Area of Science:
- Microbiology
- Infectious Diseases
- Clinical Pharmacology
Background:
- In vitro and in vivo studies have significantly advanced understanding of antimicrobial agent mechanisms.
- These studies have identified potential new treatment strategies for infectious diseases.
Purpose of the Study:
- To highlight the critical need for controlled clinical studies evaluating new antimicrobial regimens.
- To emphasize the lack of evidence for increased efficacy or reduced toxicity of new treatments compared to existing ones.
- To underscore the necessity of assessing efficacy, toxicity, and cost in chronic bacterial and fungal infections.
Main Methods:
- The abstract does not detail specific methods but emphasizes the need for "rigid, controlled clinical studies" and "carefully controlled clinical trials."
Main Results:
- The abstract does not present specific results but states that new regimens are used without proof of efficacy or reduced toxicity.
- A significant gap exists between laboratory findings and clinical validation.
Conclusions:
- There is a critical need for well-designed clinical trials to validate new antimicrobial therapies.
- Clinical validation is essential to ensure new treatments offer benefits over existing ones for chronic infections.
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