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Chemoprophylaxis during Transrectal Prostate Needle Biopsy: Interim analysis of randomized clinical trial(NCT02423759)

Abstract: PD11-07
Sources of Funding: none

Introduction

Post Transrectal biopsy infectious complications (PTBICs) are increasing due to rising fluoroquinolone resistance (FQ-R). Targeted prophylaxis based on prebiopsy rectal swabs has reduced PTBICs. However, rectal swab prior to every biopsy would create a burden for laboratories and extra costs. A randomized trial testing 3 chemoprophylaxis

Methods

Men presented for prostate biopsy were randomized to receive ciprofloxacin 500mg B.I.D for 3days from the night of biopsy(group A), augmented prophylaxis using ciprofloxacin and single prebiopsy shot of 160mg gentamycin IM(group B) and rectal swab culture based prophylaxis(group C). _x000D_ Primary end point is occurrence of postprocedure sepsis[ge]2 of SIRS (systemic inflammatory response syndrome) criteria. Inflammatory markers were used for postprocedure screening; CRP(C reactive protein), ESR(Erythrocyte sedimentation rate) and TLC(total leucocyte count). Secondary endpoint is occurrence of FQ-R in the screened men. Men were assessed 2 weeks prior to biopsy, at time of biopsy and 2 weeks after._x000D_

Results

Since November 2015, 258patients were randomized 89, 94 and 80 patients in groups A, B and C respectively. Baseline data was comparable among the 3 groups including prebiopsy urine culture with significant growth in 8 (8.9%), 8 (8.5%) and 10 (12%) in groups A, B and C respectively (P 0.6) and were treated before biopsy. _x000D_ Postprocedure fever occurred in 19 (21.3%), 9 (9.5%) and 8 (10%) in groups A, B and C respectively (P 0.03). Sepsis was reported in 5 (5.6%), 5 (5.3%) and 4 (5%) in groups A, B and C respectively (P 0.9) and 2 (2.2%) patients in group A required hospitalization. Figure 1 shows that the degree of change in TLC and ESR-1stH group was significantly more in group A than other groups (P 0.04 and 0.02 respectively). Urine culture 2 weeks after biopsy showed significant growth in 23 (25.8%), 5 (5.3%) and 11 (13.7%) in groups A, B and C respectively (P 0.002)_x000D_ Significant bacterial growth was noted in 62 (77.5%) out of 80 rectal swabs, FQ-R was reported in 55/62 (88.2%)

Conclusions

With increasing FQ-R, ciprofloxacin alone is not an optimal prophylactic approach. Augmented prophylaxis with single dose gentamycin is an effective approach. Targeted prophylaxis might be used when gentamycin is contraindicated.

Funding

none

Authors
Ahmed M. Atwa
Ahmed M. Elshal
Ahmed R. El-Nahas
Mohamed A. El-Ghar
Hashim Farg
Ali Elsorougy
Essam Elsawy
Asaad Gaber
Yasser Farag
Abdelwahab Hashem
Hossam Nabeeh
Ahmed Mosbah
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