1) Patient refusal or non-compliance to continue with the trial |
2) Patient undergoes surgical intervention related to the abscess during the study period |
3) Patient suffers a serious adverse event as a result of the study |
- drop in hemoglobin greater than 20 g/L - bleeding requiring transfusion - allergic reaction requiring medical intervention |
4) Findings observed during the study lead to early termination either due to clear benefit or disadvantages of therapy |
5) Imaging findings demonstrate worsening of the abscess either as dissemination or increase in volume > 25% |
6) White blood cell count remains elevated above the baseline recorded value 48 hours beyond intervention |
7) The drainage catheter becomes dislodged from the abscess cavity (determined by routine imaging examinations) |
8) Technical malfunction of the catheter during drug administration (fracture or hole in the catheter or the catheter is occluded) |