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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):

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Placebo Placebo: Placebo twice a day for 14 days
Ciprofloxacin Hydrochloride Ciprofloxacin hydrochloride: 250 mg Ciprofloxacin hydrochloride twice a day for 14 days

Participant Flow:   Overall Study
    Placebo   Ciprofloxacin Hydrochloride
STARTED   13   15 
COMPLETED   12   12 
NOT COMPLETED   1   3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Placebo: Placebo twice a day for 14 days
Ciprofloxacin Hydrochloride Ciprofloxacin hydrochloride: 250 mg Ciprofloxacin hydrochloride twice a day for 14 days
Total Total of all reporting groups

Baseline Measures
   Placebo   Ciprofloxacin Hydrochloride   Total 
Overall Participants Analyzed 
[Units: Participants]
 13   15   28 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Full Range)
 58.46 
 (44 to 72) 
 62.73 
 (47 to 71) 
 60.75 
 (44 to 72) 
Gender 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      13 100.0%      15 100.0%      28 100.0% 
Region of Enrollment 
[Units: Participants]
     
United States   13   15   28 


  Outcome Measures

1.  Primary:   PSA Levels (Change in PSA Levels With and Without Antibiotics Therapy)   [ Time Frame: 1 month post enrollment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: mhan1@jhmi.edu



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