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Norfloxacin for selective decontamination: a study in human volunteers
Progress in Clinical and Biological Research
|January 1, 1985
Summary
Low-dose norfloxacin effectively eliminates gut gram-negative bacilli in healthy volunteers. This dosage showed no signs of decreased colonization resistance, suggesting suitability for selective digestive decontamination (SDD).
Area of Science:
- Pharmacology
- Microbiology
- Clinical Research
Background:
- Selective digestive decontamination (SDD) is crucial in intensive care settings.
- Norfloxacin is a fluoroquinolone antibiotic with broad-spectrum activity.
- Assessing optimal dosage for efficacy and safety is essential.
Purpose of the Study:
- To evaluate the efficacy of different norfloxacin dosages in eliminating Gram-negative bacilli.
- To determine the lowest effective dose of norfloxacin for gut decontamination.
- To assess the impact of norfloxacin on colonization resistance (CR).
Main Methods:
- Ten healthy male volunteers received escalating doses of norfloxacin (200, 400, 800 mg) daily for five days.
- Fecal and oral cultures were analyzed to monitor bacterial elimination.
- Colonization resistance was assessed by monitoring for resistant organisms (e.g., ppmo) and specific metabolites (beta-asp-gly).
Main Results:
- Norfloxacin effectively eliminated Gram-negative bacilli from the gastrointestinal tract at all tested dosages.
- The lowest dose (200 mg/day) was sufficient for bacterial elimination within a reasonable timeframe.
- No decrease in colonization resistance was observed at the 200 mg/day dose.
Conclusions:
- A daily dose of 100 mg norfloxacin twice daily (200 mg total) appears suitable for SDD in volunteers.
- This dosage effectively reduces Gram-negative bacilli without compromising colonization resistance.
- Further clinical studies in patients are recommended to confirm these findings.