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Impact of Antibiotic Treatment on Prostate-Specific Antigen (PSA) Variability

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ClinicalTrials.gov Identifier: NCT00596453
Recruitment Status : Terminated (Unable to recruit enough patients)
First Posted : January 17, 2008
Results First Posted : January 23, 2017
Last Update Posted : January 23, 2017
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Diagnostic
Condition Prostate Infections
Interventions Drug: Ciprofloxacin hydrochloride
Drug: Placebo
Enrollment 31
Recruitment Details  
Pre-assignment Details 3 participants were enrolled but were removed prior to arm/group assignment. One participant was not eligible for the study and the other two participants changed their minds about being part of the research study.
Arm/Group Title Placebo Ciprofloxacin Hydrochloride
Hide Arm/Group Description Placebo: Placebo twice a day for 14 days Ciprofloxacin hydrochloride: 250 mg Ciprofloxacin hydrochloride twice a day for 14 days
Period Title: Overall Study
Started 13 15
Completed 12 12
Not Completed 1 3
Arm/Group Title Placebo Ciprofloxacin Hydrochloride Total
Hide Arm/Group Description Placebo: Placebo twice a day for 14 days Ciprofloxacin hydrochloride: 250 mg Ciprofloxacin hydrochloride twice a day for 14 days Total of all reporting groups
Overall Number of Baseline Participants 13 15 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 15 participants 28 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
  76.9%
8
  53.3%
18
  64.3%
>=65 years
3
  23.1%
7
  46.7%
10
  35.7%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 13 participants 15 participants 28 participants
58.46
(44 to 72)
62.73
(47 to 71)
60.75
(44 to 72)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 15 participants 28 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
13
 100.0%
15
 100.0%
28
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 15 participants 28 participants
13 15 28
1.Primary Outcome
Title PSA Levels (Change in PSA Levels With and Without Antibiotics Therapy)
Hide Description

We took 4 Prostate Specific Antigen (PSA, ng/mL) measurements per participant. The first PSA test was performed at enrollment. The second PSA test was performed 7 days (+/-3 days) later. Then the participants took the Placebo or Cipro for 14 days. The participants returned for their 3rd PSA test upon completion of the Placebo or Cipro. The final PSA test was performed 7 days (+/-3 days) after the 3rd test.

We planned to compare the differences between the first two PSA tests and the last two PSA tests in the Placebo vs Cipro groups.

Time Frame 1 month post enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Ciprofloxacin Hydrochloride
Hide Arm/Group Description:
Placebo: Placebo twice a day for 14 days
Ciprofloxacin hydrochloride: 250 mg Ciprofloxacin hydrochloride twice a day for 14 days
Overall Number of Participants Analyzed 13 15
Mean (Standard Deviation)
Unit of Measure: ng/mL
1.23  (0.6) 0.52  (0.59)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Ciprofloxacin Hydrochloride
Hide Arm/Group Description Placebo: Placebo twice a day for 14 days Ciprofloxacin hydrochloride: 250 mg Ciprofloxacin hydrochloride twice a day for 14 days
All-Cause Mortality
Placebo Ciprofloxacin Hydrochloride
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Ciprofloxacin Hydrochloride
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Ciprofloxacin Hydrochloride
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/13 (7.69%)      1/15 (6.67%)    
Gastrointestinal disorders     
Diarrhea  1/13 (7.69%)  2 1/15 (6.67%)  4
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Misop Han, M.D.
Organization: Johns Hopkins Medical Institutions
Phone: 410-502-7454
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00596453     History of Changes
Other Study ID Numbers: NA_00010549
First Submitted: January 8, 2008
First Posted: January 17, 2008
Results First Submitted: August 16, 2016
Results First Posted: January 23, 2017
Last Update Posted: January 23, 2017