Comparison of Fluoroquinolones and Other Antibiotic Prophylaxis Regimens for Preventing Complications in Patients Undergoing Transrectal Prostate Biopsy

Round 1

Reviewer 1 Report

The authors in this study evaluated the efficacy of various antibiotics regimens by comparing the incidence of infective complications after transrectal ultrasound-guided prostate biopsy via retrospective cohort study design. The findings are conclusive and good to publish.

Levofloxacin was the most frequent among fluoroquinolones-based regimens. Will there be any difference in the efficacy of other fluoroquinolones? Can authors discuss the efficacy of other fluoroquinolones like ciprofloxacin for the prevention? Will it be the same or comparable or do they recommend only levofloxacin as the best option. I know it is a retrospective study and authors can only present what they found in the data but what is their opinion or what they can discuss from previous literature published in this regard

Author Response

Editor

Lois Liu

Assistant Editor

Dorothy Liu

ANTIBIOTICS

 

Palermo, Feb 28^th 2022

 

Manuscript #: ANTIBIOTICS-1597891

Title: COMPARISON BETWEEN FLUOROQUINOLONES AND OTHER ANTIBIOTIC PROPHYLAXIS REGIMENS IN PREVENTING INFECTIVE COMPLICATIONS IN PATIENTS UNDERGOING TRANSRECTAL PROSTATE BIOPSY

 

 

Dear Editors,

 

Thanks for considering our manuscript for publication in the ANTIBIOTICS. We appreciated the comments made by the reviewers and we prepared a revised version of our manuscript based on these comments. Please also find a point-by-point “response to reviewers” below. We hope you can find this revised version of our manuscript fully suitable for publication in your esteemed journal.

 

Kindest regards

Gabriele Tulone, MD

 

 

 

 

 

 

 

 

 

 

 

 

 

Reviewer: 1

The authors in this study evaluated the efficacy of various antibiotics regimens by comparing the incidence of infective complications after transrectal ultrasound-guided prostate biopsy via retrospective cohort study design. The findings are conclusive and good to publish.

Levofloxacin was the most frequent among fluoroquinolones-based regimens. Will there be any difference in the efficacy of other fluoroquinolones? Can authors discuss the efficacy of other fluoroquinolones like ciprofloxacin for the prevention? Will it be the same or comparable or do they recommend only levofloxacin as the best option. I know it is a retrospective study and authors can only present what they found in the data but what is their opinion or what they can discuss from previous literature published in this regard

 

Thanks for your review. It could be very useful to study the effectiveness of the different quinolones but unfortunately the sample is very small for prulifloxacin and ciprofloxacin so we preferred to evaluate the entire class of quinolones. A future study can be plan to check for any differences.

 

Reviewer 2 Report

The manuscript submitted by Tulone et al., entitled "Comparison between Fluoroquinolones and other Antibiotic Prophylaxis Regimens in Preventing Infective Complications in Patients Undergoing Transrectal Prostate Biopsy," is quite interesting. The subject is interesting, and presenting more clinical data will improve the prophylactic strategy for prostate biopsy.

The manuscript is not well written and organized, and the English need significant improvements before it can be processed further.

Here are my comments:

1. Please delete from abstract- background, methods, conclusions.
2. Introduction:
   1. l. 53-55 references 2 and then 8-9?? Please check the number of references through the whole manuscript
   2. l. 60-62 needs a reference
   3. l. 65 [ref]????
   4. l.67-69 reference 12 is inadequate; the authors refer to EAU and AUA guidelines
   5. l. 75-78 hard to understand
   6. Please include the following articles in the Introduction and Discussion section
      •  https://doi.org/10.3389/fsurg.2018.00002
      • https://doi.org/10.1186/s12894-020-00592-8
      • https://doi.org/10.1186/s12301-020-00026-9
      • 10.12688/f1000research.19260.1
3. Results
   1. Include the tables in the Results section.
   2. Table 1 - Complications - no UTIs? 
   3. Please detail the reasons for unplanned visits and unplanned readmission in the result section.
4. Discussion should first summarize one or two key findings of the study. Why are those findings important in light of previous observations? How we can use these findings in developing antibiotic prophylaxis for prostate biopsy. Do not present at the beginning of the section some limitations.
   1. l.132-134 needs some references
   2. l. 161 - 166 the authors should present recent data, especially from Europe: 
      https://doi.org/10.31925/FARMACIA.2021.3.16 
      https://doi.org/10.3390/microorganisms8060848
   3. l. 167-170, the information presented is not correct. The EAU guidelines on prostate cancer - ``Ultrasound (US)-guided biopsy is now the standard of care. Prostate biopsy is performed by either the transrectal or transperineal approach``.
   4. Please include the limitations of the study.
5. Materials and methods
   1. l. 180 Please specify the centers
   2. l. 183 needs a reference
   3. describe clearly the dose of antibiotics, mode, and time of administration
   4. l. 213-216 hard to understand, please describe ``a rigid scheme of antibiotic prophylaxis``
   5. Please specify if the patients had enema the night before or on the morning of the procedure
6. Conclusions need to be revised
   1. ``In diabetic patients the different pharmacological efficacy against the infectious risk is probably caused by the different pathogens pharmacological resistance.`` is based on what results???
7. Please arrange the whole manuscript and review the references according to journal requirements.

 

 

Author Response

Editor

Lois Liu

Assistant Editor

Dorothy Liu

ANTIBIOTICS

 

Palermo, Feb 28^th 2022

 

Manuscript #: ANTIBIOTICS-1597891

Title: COMPARISON BETWEEN FLUOROQUINOLONES AND OTHER ANTIBIOTIC PROPHYLAXIS REGIMENS IN PREVENTING INFECTIVE COMPLICATIONS IN PATIENTS UNDERGOING TRANSRECTAL PROSTATE BIOPSY

 

 

Dear Editors,

 

Thanks for considering our manuscript for publication in the ANTIBIOTICS. We appreciated the comments made by the reviewers and we prepared a revised version of our manuscript based on these comments. Please also find a point-by-point “response to reviewers” below. We hope you can find this revised version of our manuscript fully suitable for publication in your esteemed journal.

 

Kindest regards

Gabriele Tulone, MD

 

 

 

 

 

 

 

 

 

 

 

 

 

Reviewer: 2

The manuscript submitted by Tulone et al., entitled "Comparison between Fluoroquinolones and other Antibiotic Prophylaxis Regimens in Preventing Infective Complications in Patients Undergoing Transrectal Prostate Biopsy," is quite interesting. The subject is interesting and presenting more clinical data will improve the prophylactic strategy for prostate biopsy.

Here are my comments:

1. We delete from the abstract background, methods and conclusion
2. Introduction:
3. 60-62 needs a reference:

 

Tahnks for your comment. We added the follow references:

[13] Aron, M., et al. Antibiotic prophylaxis for transrectal needle biopsy of the prostate: a randomized controlled study. BJU Int, 2000. 85: 682.

 

[9]. Abdelkhalek, M.; Abdelshafy, M.; Elhelaly, H.; et al. Hemosepermia after transrectal ultrasound-guided prostatic biopsy: A prospective study Urol Ann. 2013 Jan-Mar

 

l.67-69 reference 12 is inadequate; the authors refer to EAU and AUA guidelines

 

Thanks, we refer to the EAU and AUA guidelines before the EAU restriction

[13] Aron, M., et al. Antibiotic prophylaxis for transrectal needle biopsy of the prostate: a randomized controlled study. BJU Int, 2000. 85: 682.

 

 

1. 75-78 hard to understand

 

We reformulated the sentence:

The aim of our study is to compare the incidence of complications after TRUSBx. In particular, we reported  the events in relation of the use of different class of antibiotics prophylaxis.

 

Please include the following articles in the Introduction and Discussion section

 

Thanks a lot for the advice and for the interesting article that we included in the manuscript (Ref. 8, 12, 31)

 

Results

Include the tables in the Results section

 

We included table in the Results

 

Table 1 - Complications - no UTIs? 

 

Thanks for the observation. We could not include the UTIs in the complications because in most of the cases urinary infections were treated by the GP and we were not able to collect the data of interest. We added this as a  limitation of our study

 

Please detail the reasons for unplanned visits and unplanned readmission in the result section.

 

Thanks for your suggestion. We detailed the reason for unplanned visits e readmission in the table

 

1. Discussion should first summarize one or two key findings of the study. Why are those findings important in light of previous observations? How we can use these findings in developing antibiotic prophylaxis for prostate biopsy. Do not present at the beginning of the section some limitations.

 

Thanks for you guidance. We refolmulated the paraghraph as it follows.

In recent years there has been an increase in antibiotic resistance, like fluoroquinolones, and many scientific efforts are aimed at researching new antibiotics. This article opens an important discussion on the possibility of reintroducing drugs such as quinolones that have been banned by the EMA in recent years.

 

l.132-134 needs some references

 

Ref 16 Pilatz, A.; Veeratterapillay, R.; Dimitropoulos, K.; et al. European Association of Urology Position Paper on the Prevention of Infectious Complications Following Prostate Biopsy, European Urology, 2019

 

10. 161 - 166 the authors should present recent data, especially from Europe: 
    https://doi.org/10.31925/FARMACIA.2021.3.16 
    https://doi.org/10.3390/microorganisms8060848

 

Thanks, we include in the manuscript Ref 30 – 31

30)Chibelean, C. B.; Petca, R.C.; et al.A Clinical Perspective on the Antimicrobial Resistance Spectrum of Uropathogens in a Romanian Male Population Mares Microorganisms, June 2020

31)Styrke, J.;, Resare, S.; Lundström, K.J.; Current routines for antibiotic prophylaxis prior to transrectalprostate biopsy: a national survey to all urology clinics in Sweden. F1000Research 2020

 

1. 167-170, the information presented is not correct. The EAU guidelines on prostate cancer - ``Ultrasound (US)-guided biopsy is now the standard of care. Prostate biopsy is performed by either the transrectal or transperineal approach``.

 

Thanks for the advice. We rechecked the EAU recommendation 2021 That are recommending the transperineal technique as the gold standard

 

Please include the limitations of the study.

 

Thanks for your suggestions. We formulated the paragraphs.  We have not included the UTIs in the because in most cases urinary infections were treated by the GP, we could not trace the data of interest. This must be considered the limitation of our study.

 

Materials and methods

1. 180 Please specify the centers

 

We specified the centers: Palermo, Pisa, Cuneo

 

1. 183 needs a reference

 

We added reference 34

 

describe clearly the dose of antibiotics, mode, and time of administration

 

We described mode and time of antibiotics administration in the manuscript I 322, 323, 324

 

1. 213-216 hard to understand, please describe ``a rigid scheme of antibiotic prophylaxis``

 

We added the scheme I 322 – 323

 

Please specify if the patients had enema the night before or on the morning of the procedure

 

Specified: I. 324 -325

 

Conclusions need to be revised

``In diabetic patients the different pharmacological efficacy against the infectious risk is probably caused by the different pathogens pharmacological resistance.`` is based on what results??

 

Thanks for your advice. Because this was not the aim of our study we removed the consideration from the conclusion.

Round 2

Reviewer 2 Report

Dear Authors, 

The article presents some improvements, but it is still insufficient. The authors should try to address all the suggestions from my previous report, not only insert a few sentences. The manuscript is not well written and organized, and the English need significant improvements before it can be processed further. All the sections need to be revised. 

Please find other suggestions, and try to address all from my previous:

1. The authors should delete from title ``infective`` and leave only complications because they do not present data regarding UTIs
2. l. 68-69. The references are still inadequate. The authors must cite EAU and AUA guidelines.
   l. 69-74 needs some references
3. The authors should present the complications in each antibiotic prophylaxis group.
4. l. 136-138 needs reference
5. l. 192 ref 31 is not from an Eastern Europe
6. l. 195 The EAU guidelines on prostate cancer - ``Ultrasound (US)-guided biopsy is now the standard of care. Prostate biopsy is performed by either the transrectal or transperineal approach``. It is not the gold standard; it is the recommended approach. l. 195-199 needs a reference.
7. l. 213 Please delete ``All patients underwent TRUSBx``, the information is presented - l 210-211.
8. The following suggestions have not been appropriately addressed by the authors (in the article, the information is not present, as suggested in the cover letter)
   1. describe clearly the dose of antibiotics, mode, and time of administration
   2. Please specify if the patients had enema the night before or on the morning of the procedure
   The title of subsection 4.2 should be modified (actually, it should be before statistical analysis) - Antibiotic prophylaxis, patient preparation, and technique of TRUSBx
9. l. 256 it is not clear what authors understand by secondary prevention therapies
10. l. 259-260 should be deleted
11. The Discussion sections must be revised.
12. The Reference list should respect Journal requirements.

 

 

Author Response

Editor

Lois Liu

Assistant  Editor

Dorothy Liu

 

ANTIBIOTICS

 

Palermo, March 14^th 2022

 

Manuscript #: ANTIBIOTICS-1597891

Title: COMPARISON BETWEEN FLUOROQUINOLONES AND OTHER ANTIBIOTIC PROPHYLAXIS REGIMENS IN PREVENTING COMPLICATIONS IN PATIENTS UNDERGOING TRANSRECTAL PROSTATE BIOPSY

 

 

Dear Editors,

 

Thanks for considering our manuscript for publication in the ANTIBIOTICS. We appreciated the new comments made by the reviewer and we prepared a revised version of our manuscript based on these comments. Manuscript has undergone English language editing by MDPI as recommended.  Please also find a point-by-point “response to reviewer” below. We hope you can find this revised version of our manuscript fully suitable for publication in your esteemed journal.

 

Kindest regards

Gabriele Tulone, MD

 

Manuscript has undergone English language editing by MDPI as recommended

 

1. The authors should delete from title ``infective`` and leave only complications because they do not present data regarding UTIs

 

As recommended we change the Title of the manuscript removing “infective”

 

1.  68-69. The references are still inadequate. The authors must cite EAU and AUA guidelines.
    69-74 needs some references

 

We have added references on the advice on the use of levofloxacin as a prophylaxis of transrectal prostate biopsy. These are the European and American guidelines of 2018. In addition we have also included the EMA note on the restriction of the use of this class of anti-antibiotics (EMEA / H / A-31/1452 and UAE 2021) as indicated in the European guidelines of 2021

 

3. The authors should present the complications in each antibiotic prophylaxis group

 

Unfortunately we cannot go back to this data of the single complications for a single drug which is certainly useful. In the manuscript we preferred to focus on infectious complications, fever and sepsis. We decide to evaluate the complications related to the diabetes as described in tab. 2. A subsequent and prospective study may also focus on the other complications related to the single antibiotic.

 

4. 136-138 needs reference

As recommended we have included a reference. In the article by Yanshu Jia and Liyan Zhao entitled The antibacterial activity of fluoroquinolone derivatives: An update (2018 - 2021), published in Eur J Med Chem 2021 Nov 15; 224: 113741. doi: 10.1016 / j.ejmech.2021.113741 discusses the increased incidence of quinolone resistance among Gram-positive bacteria (including Enterococcus faecalis / E. faecalis and Enterococcus faecium / E. faecium) and Gram-negative (including Escherichia coli / E. coli, Pseudomonas aeruginosa / P. aeruginosa, and Klebsiella pneumonia / K. pneumonia).

 

5. 192 ref 31 is not from an Eastern Europe

 

Thank we corrected the answer 

 

6.  The EAU guidelines on prostate cancer - ``Ultrasound (US)-guided biopsy is now the standard of care. Prostate biopsy is performed by either the transrectal or transperineal approach``. It is not the gold standard; it is the recommended approach. l. 195-199 needs a reference.

 

Thanks for the advise. It is true that the guidelines recommend the perineal approach and still cannot be considered as the gold standard. We have added a meta-analysis conducted by Xiang et al in which the possible complications related to the two procedures are also mentioned. Particularly in the case of perineal biopsy there is a greater risk of post procedural perineal pain.

 

7. 213 Please delete ``All patients underwent TRUSBx``, the information is presented - l 210-211.

 

We eliminated the repetition

 

8. The following suggestions have not been appropriately addressed by the authors (in the article, the information is not present, as suggested in the cover letter)
   describe clearly the dose of antibiotics, mode, and time of administration
   2. Please specify if the patients had enema the night before or on the morning of the procedure
   The title of subsection 4.2 should be modified (actually, it should be before statistical analysis) - Antibiotic prophylaxis, patient preparation, and technique of TRUSBx

 

we insert in the manuscript a table with type, mode and time of administration of antibiotic prophylaxis

 

Type of antibiotc	Mode of administration	Time of administration
Cefixime 400 mg	Oral	The night before and the morning of the procedure
Ceftriaxone 1 g / Fosfomycin 3 g	Fosfomycin: Oral administration Ceftriaxone: Administration  within a muscle.	Fosfomycin: The night before and the morning of the procedure Ceftriaxone: one shot before the biopsy
Trimethoprim 160 mg / Sulfamethoxazole 800 mg	Oral	The night before and the morning of the procedure
Ciprofloxacin 500 mg	Oral	The night before and the morning of the procedure
Levofloxacin 500 mg	Oral	The night before and the morning of the procedure
Prulifloxacin 600 mg	Oral	The night before and the morning of the procedure

 

We fixed rectal cleansing with enema. All patients had enema the night before and the morning of the procedure

 

We modified the title of subsection 4.2 as advised.

 

9. 256 it is not clear what authors understand by secondary prevention therapies

 

The sentence is for patients with positive pre-procedure urine culture. They performed targeted therapy

 

 

10. 259-260 should be deleted

 

We deleted the answer

 

11. The Discussion sections must be revised.

 

We revised and corrected the discussion by integrating the suggestions made by the reviewers, making the text more organic and complete also thanks to the new references that give greater strength to the text. In addition, a English language editing by the MDPI corrected the errors present and made the text more fluent.

 

12. The Reference list should respect Journal requirements.

 

We correct the references respecting journal requirements