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Study comparing the efficacy of fosfomycin and ciprofloxacin antibiotics in the antibiotic prophylaxis of transrectal prostate biopsy

Comparative study between fosfomycin and ciprofloxacin in transrectal prostate biopsy prophylaxis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9tk9pwz
Enrollment
Unknown
Registered
2021-11-23
Start date
2021-04-08
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prostatite

Interventions

The final sample number was 115 participants, who were randomized, over the time of recruitment, in order of biopsy indication into two groups. The intervention group (57 patients) performed the proph
D03.633.100.810.835.322.186
D02.705.429.625

Sponsors

Universidade Federal do Paraná - Campus Toledo
Lead Sponsor
Universidade Federal do Paraná - Campus Toledo
Collaborator

Eligibility

Sex/Gender
Male
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: male gender; have a formal indication for prostate biopsy; aged between 18 and 100 years.

Exclusion criteria

Exclusion criteria: patients who for some reason cannot take the proposed medications; patients with a history of severe bleeding complications during the biopsy procedure.

Design outcomes

Primary

MeasureTime frame
Occurrence of infectious complications, which include genitourinary infection (symptoms of fever, chills and dysuria) with or without fever and asymptomatic bacteriuria, evaluated after the patients' return visit, in the medical record, and urine culture performed 10 days after the biopsy procedure, in each group, through the relative and absolute frequency of the occurrence.

Secondary

MeasureTime frame
The Prostate Specific Antigen (PSA) level was obtained from the patients' medical records through the relative and absolute rate in each group. The PSA levels found were mostly between 4-10 nanograms per milliliter (ng/ml) (64.3%). Levels below 4 ng/ml and above 10 ng/ml represent 18.3% of the sample and 17.4%, respectively. ;Previous use of a urinary catheter was evaluated in the patients' medical records, through the absolute and relative frequency, representing 1.7% of the patients. ;Uroculture and bacterial resistance 10 days after biopsy in patients who had symptoms of infectious complications, was evaluated in medical records using absolute and relative frequency. Only 1.7% of patients had positive urine culture and bacterial resistance in both cases.;The use of antibiotics in the last three months was evaluated in the patients' medical records through the absolute and relative frequency, corresponding to 2.6% of the patients. ;The personal history of Diabetes Melitus was evaluated in the patients' medical records through the relative and absolute frequency in each group. In all, 13% of patients had diabetes. ;The result of the anatomopathological study of the participants' prostate biopsies was evaluated in the medical record using absolute and relative frequency. Regarding the results of biopsies, most participants were diagnosed with adenocarcinoma (52.2%) followed by benign prostatic hyperplasia (BPH) (44.3%), followed by atypical proliferation of small acids (7%) and prostatitis ( 1.7%).

Countries

Brazil

Contacts

Public ContactDaiane de Souza
daiane_souzab@hotmail.com+55(44)9995-44726

Outcome results

None listed

Source: REBEC (via WHO ICTRP)