antimicrobial resistance in Escherichia coli
Conditions
Brief summary
If from the descriptive plots (see secondary objective 1) it becomes evident that there is an individual location shift (but the shape of the distribution remains the same), the individual difference in median ciprofloxacin MIC will be calculated (after intervention – baseline). Otherwise, the maximum absolute distance between the two individual empirical cumulative empirical distributions (ecdf’s) will be calculated (i.e. Kolmogorov-Smirnov test statistic).
Detailed description
Individual MIC distributions, Percentage of inhibited E. coli at the prespecified concentrations of ciprofloxacin per participant and per time point (baseline and after administration of the intervention/placebo)., Percentage of inhibited E. coli ciprofloxacin MIC ≥ 0.125 mg/L per participant and per time point (baseline and after administration of the intervention/placebo). This coincides with the sum of % inhibited at ciprofloxacin MIC = 0.125 mg/L and ciprofloxacin MIC = 0.250 mg/L., All above mentioned endpoints will be repeated for “non-E.coli coliforms", Concentration of ciprofloxacin in feces at day 0 and 30
Interventions
DRUGSyrSpend SF
DRUGCiprofloxacin Kabi 200 mg/100 ml solution for infusion
Sponsors
Institute Of Tropical Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| If from the descriptive plots (see secondary objective 1) it becomes evident that there is an individual location shift (but the shape of the distribution remains the same), the individual difference in median ciprofloxacin MIC will be calculated (after intervention – baseline). Otherwise, the maximum absolute distance between the two individual empirical cumulative empirical distributions (ecdf’s) will be calculated (i.e. Kolmogorov-Smirnov test statistic). | — |
Secondary
| Measure | Time frame |
|---|---|
| Individual MIC distributions, Percentage of inhibited E. coli at the prespecified concentrations of ciprofloxacin per participant and per time point (baseline and after administration of the intervention/placebo)., Percentage of inhibited E. coli ciprofloxacin MIC ≥ 0.125 mg/L per participant and per time point (baseline and after administration of the intervention/placebo). This coincides with the sum of % inhibited at ciprofloxacin MIC = 0.125 mg/L and ciprofloxacin MIC = 0.250 mg/L., All above mentioned endpoints will be repeated for “non-E.coli coliforms", Concentration of ciprofloxacin in feces at day 0 and 30 | — |
Countries
Belgium
Outcome results
None listed