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Short-course (7‑day) versus standard 14‑day ciprofloxacin treatment for men with serious urinary tract infection

Fast replyRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

A Urinary tract infection that spreads beyond the bladder and causes fever, flank pain, low blood pressure, or high levels of inflammation in the blood is being studied. The infection is treated with the oral antibiotic ciprofloxacin, which is taken as a tablet. In some cases a matching placebo capsule that looks the same as the antibiotic may be used to keep the study blinded.

The purpose of the study is to determine whether a shorter, 7‑day course of the antibiotic works as well as the standard 14‑day course in achieving a cure of the infection.

Participants are randomly assigned to receive either the short or the longer treatment. After finishing the medication, they are followed up with visits about two weeks and four weeks later to check whether symptoms have resolved, whether the infection has returned, and whether any side effects have occurred. “Clinical cure” means the patient’s signs and symptoms have returned to normal and no additional antibiotics are needed.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joined trial
After providing informed consent, baseline information such as medical history, current symptoms, and laboratory results is recorded.
The trial staff confirms eligibility for a male urinary tract infection with systemic involvement.
Step 2
Randomization
The participant is randomly assigned to one of two treatment groups: a short course of ciprofloxacin for 7 days or a longer course for 14 days.
The assignment is kept confidential to maintain the blind nature of the study.
Step 3
Receive medication
The participant receives oral tablets containing ciprofloxacin 500 mg each.
The total daily dose is 1500 mg, usually taken as three tablets taken at evenly spaced times during the day.
If assigned to the short‑course group, matching placebo tablets are provided for the remaining days to keep the number of pills taken consistent.
Step 4
Treatment period
The participant takes the prescribed tablets exactly as instructed.
For the short‑course group, the ciprofloxacin tablets are taken for 7 days followed by placebo tablets for the next 7 days; for the long‑course group, the tablets are taken for the full 14 days.
Any new symptoms, side effects, or concerns are recorded in a diary and reported to the trial staff during scheduled contacts.
Step 5
Completion of medication
After the assigned number of days (7 or 14), the participant stops taking the study tablets.
The participant is reminded to keep the medication bottle for possible verification.
Step 6
First follow‑up (day 14 after end of treatment)
A visit or telephone contact is scheduled 14 days after the last dose.
The staff assesses clinical cure, meaning resolution of fever, flank pain, blood pressure, and laboratory markers to the state before the infection.
The participant is asked about any new urinary infections, side effects, or need for additional antibiotics.
Step 7
Second follow‑up (day 28 after end of treatment)
A second assessment occurs 28 days after the last dose.
The evaluation includes checking for late relapse or recurrence of urinary infection, any infection‑related deaths, hospital readmissions, and other adverse events.
The information is recorded for the study outcomes.

Who can join the trial?

6 criteria

Be a male who is 18 years old or older.
Have a urinary tract infection (UTI) with systemic involvement, which means the infection is affecting the whole body and may cause fever (temperature ≥ 38 °C), side or back pain, low blood pressure (systolic < 90 mm Hg), high inflammation markers in blood tests, or bacteria found in the blood.
Have a monobacterial UTI – the infection is caused by only one type of bacteria.
Have already started an empiric antibiotic treatment – an antibiotic chosen before the exact bacteria is known, using one of the approved medicines in the study.
The bacteria causing the infection must be ciprofloxacin‑sensitive, meaning this specific antibiotic can effectively kill it.
Be haemodynamically stable at the time of joining the study, which means you are not in sepsis or septic shock (a severe infection that causes dangerously low blood pressure and organ problems).

Who cannot join the trial?

22 criteria

Expected life expectancy shorter than 30 days – meaning the person is not expected to live more than about one month.
Conditions that may prevent oral medication from reaching effective levels, such as difficulty swallowing or problems absorbing the drug from the gut.
Participation in any other clinical study that tests a new treatment for a urinary tract infection.
Having a urinary tract infection caused by a bacteria that requires a higher dose of ciprofloxacin, for example Pseudomonas aeruginosa.
Needing a lower dose of ciprofloxacin than the study’s standard (less than 500 mg taken twice daily).
Having received an active antibiotic that targets the identified bacteria for less than 72 hours before being considered for the study.
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Any absolute reason not to use ciprofloxacin, including:
- known allergy to ciprofloxacin,
- taking the medication tizanidine,
- having G6PD deficiency (a blood enzyme problem),
- a history of tendon problems caused by fluoroquinolone antibiotics,
- a heart rhythm issue called long QTc (interval > 450 ms) unless cleared by a heart doctor,
- previous psychiatric side effects from fluoroquinolone drugs,
- having myasthenia gravis (a muscle‑weakness disorder).
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  Having certain urinary tract or related problems, such as:
  - a permanently placed urinary catheter,
  - infection of a kidney cyst,
  - inflammation of the epididymis or testicles (epididymitis or orchitis),
  - infection of a transplanted kidney,
  - severe kidney infection called encrusted pyelonephritis,
  - any surgical diversion of the urinary tract,
  - an untreated abscess in the urinary tract,
  - chronic prostatitis,
  - being on permanent dialysis or having very poor kidney function (glomerular filtration rate ≤ 20 ml/min).

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Az St-Jan Brugge-Oostende A.V.
Brugge, Belgium
Responsive
Katholieke Universiteit te Leuven
Leuven, Belgium
Responsive
Universitair Ziekenhuis Gent
Gent, Belgium

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Investigated drugs

Ciprofloxacin is an oral antibiotic that works by stopping the growth of bacteria that cause infections. In this trial, participants with male urinary tract infections that have spread to the bloodstream or other parts of the body took ciprofloxacin tablets. The study compared two treatment lengths: a short course of about one week (at least four days of the medicine, total seven days) and a longer course of two weeks. The goal was to see if the shorter treatment could cure the infection just as well as the longer one.

Ciprofloxacin

What is already known about the treatment

Ciprofloxacin - Ciprofloxacin is taken by mouth as a film‑coated tablet that is swallowed with water. It is a widely used fluoroquinolone antibiotic that has been on the market for decades and is well documented in medical literature. The drug is mainly prescribed for urinary tract infections with systemic involvement, as well as for other bacterial infections such as gastrointestinal and respiratory infections. It works by blocking bacterial enzymes called DNA gyrase and topoisomerase IV, which are needed for the bacteria to copy their DNA, thereby stopping bacterial growth.

Investigated diseases

Urinary tract infection with systemic involvement - It is an infection of the urinary system that spreads enough to cause signs throughout the body. It starts when bacteria enter the bladder or kidneys and then trigger fever, flank pain, low blood pressure, or high inflammatory markers. As the infection progresses, the bacteria may enter the bloodstream, leading to bacteremia. The condition often begins with localized urinary symptoms and then expands to cause systemic signs. The disease course can include worsening of fever and pain if the infection is not resolved.