Clinical trial NCT04985110: Administration of Antibiotic Prophylaxis for Transperineal Prostate Biopsy in Cipto Mangunkusumo Hospital
Official title: Pemberian Antibiotik Profilaksis Pada Biopsi Prostat Transperineal di RSUPN Dr. Cipto Mangunkusumo: Uji Klinis Acak Terkontrol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Prostate Cancer
Prostate Biopsy
Perioperative Complication
Bacteriuria
Urinary Tract Infections
Sepsis
Keywords: Antibiotic prophylaxis
Transperineal prostate biopsy
Randomized controlled trial
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2021-08-02
Enrollment: 78
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This randomized controlled trial aims to compare the rate of perioperative infection complications in transperineal prostate biopsy between the group that receives prophylactic antibiotic and the group that receives placebo.
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial aims to compare the rate of perioperative infection complications in transperineal prostate biopsy between the group that receives prophylactic antibiotic and the group that receives placebo. The types of infection studied included bacteriuria, urinary tract infection (UTI), UTI with fever (febrile UTI), and sepsis. This study hypothesized that the administration of prophylactic antibiotics during transperineal prostate biopsy would result in lower rates of perioperative infection complications.

Detailed description: Prostate cancer screenings will be conducted in all patients aged \>45 years with lower urinary tract symptoms (LUTS) through PSA test and digital rectal examination (DRE). Those with PSA levels of 4.0 ng/mL or higher or other abnormal findings on DRE will be recommended to undergo transperineal prostate biopsy. In addition, participants will be offered to participate in this clinical trial, in which participants will be randomly assigned into two groups: one group will receive prophylactic antibiotic, while the other group will receive placebo.

The randomization process will be conducted before the biopsy procedure. Computers will generate random numbers, which will put the participants into two groups. These numbers can only be accessed by the research monitor (Clinical Research Supporting Unit of IMERI FMUI), while the investigators, surgeons, residents, and nurses involved will be blinded to this information. To ensure patient blinding, the placebo and cotrimoxazole forte 960 mg will be reformed as identical as possible in capsule preparation.

The primary outcomes of this clinical trial are the rate of perioperative infection complications, including bacteriuria, urinary tract infection (UTI), UTI with fever (febrile UTI), and sepsis, in 24 hours, 7 days, and 14 days postoperatively. The secondary outcomes of this clinical trial are the rate of readmission.

Eligibility criteria: Inclusion Criteria:

* Patient with lower urinary tract symptoms aged \>45 years with either PSA levels of 4.0 ng/mL or higher or abnormal findings on digital rectal examination (DRE)
* Patient with a negative initial urine culture / urinalysis test

Exclusion Criteria:

* Patients who refuses to undergo transperineal prostate biopsy
* Patients who refuses to participate in the research
* Patient who is unable to communicate effectively
* Patient with a documented history of cotrimoxazole allergy
* Patient who has consumed antibiotics for other indications prior to undergoing prostate biopsy
* Patient with urinary tract infection symptoms prior to undergoing prostate biopsy
* Patient with a history of immunodeficiency disorders or long-term corticosteroid use
* Patient with a history of prostate cancer
* Patient with a history of prior prostate biopsy

Primary outcomes:
measure: Incidence of infection complications
timeFrame: 24 hours
measure: Incidence of infection complications
timeFrame: 7 days
measure: Incidence of infection complications
timeFrame: 14 days
Secondary outcomes:
measure: Rate of readmission
timeFrame: 7 days
measure: Rate of readmission
timeFrame: 14 days
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Dr. Cipto Mangunkusumo Hospital
state: DKI Jakarta
Study officials:
affiliation: Universitas Indonesia - Cipto Mangunkusumo Hospital
name: Agus Rizal A. H. Hamid, M.D, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitas Indonesia - Cipto Mangunkusumo Hospital
name: Harun Wijanarko Kusuma Putra, M.D, B.Med.Sci(Hons)
role: STUDY_CHAIR
affiliation: Fatmawati General Hospital, Jakarta - Indonesia
name: Syamsu Hudaya, M.D.
role: STUDY_DIRECTOR
affiliation: Persahabatan Central General Hospital, Jakarta - Indonesia
name: Hendy Mirza, M.D.
role: STUDY_DIRECTOR
affiliation: Universitas Indonesia, Depok - Indonesia
name: Dyandra Parikesit, B.Med.Sc., M.D.
role: STUDY_DIRECTOR
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