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Uncomplicated Urinary Tract InfectionPhase 3NCT05545137

Clinical Trial of Pivmecillinam Hydrochloride Tablets in the Treatment of Uncomplicated Urinary Tract Infection

A Phase 3 study testing Pivmecillinam hydrochloride tablets and Fosfomycin Tromethamine Granules in people with Uncomplicated Urinary Tract Infection, run by Benova (Tianjin) Innovative medicine Research Co., Ltd. at 10 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

the purpose of this study is to evaluate the efficacy and safety of pivmecillinam hydrochloride tablets in the treatment of uncomplicated urinary tract infection in China Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Uncomplicated Urinary Tract Infection
What is being tested?
Pivmecillinam hydrochloride tablets and Fosfomycin Tromethamine Granules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
299 participants
Where
10 sitesChina
Study dates
29 Sep 2022to 20 Feb 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients over 18 years of age with uncomplicated urinary tract infection ;
  • Within 72 hours prior to study entry, the following symptoms or signs occurred: frequency of urine, urgency, dysuria (including suprapubic pain, pain or burning sensation on urination), dysuria, and symptom score ≥ 2 points;
  • Urinalysis showed leukocyturia, i.e.,white blood cells≥ 10/μl on non-centrifuged urinalysis and white blood cell count greater than the upper limit of normal at the study site or white blood cells>5 /HP（high-power） on microscopic examination of urine sediment;
  • Those who have no childbearing plan within the past 6 months (women of childbearing potential have a negative urine pregnancy test result at screening or within 72 hours before starting the trial) and agree to use effective non-drug contraception during the study;
  • Subjects who agree to participate in this clinical trial and sign a written informed consent form (ICF);

Who cannot join

  • Patients with acute or chronic upper urinary tract infection (eg, temperature > 38 °C, chills, or costovertebral angle pain, etc.);
  • Other factors predisposing to urinary tract infection, including patients with known structural or functional abnormalities of the urinary tract such as urinary calculi;
  • Patients with indwelling catheterization or urinary incontinence;
  • Patients who have taken drugs for treatment of urinary tract infection or antibiotics for other diseases within 48 hours prior to dosing are excluded if the half-life of antibiotics taken by the subject is long and cannot be basically cleared before dosing as judged by the investigator, even if they have not taken any antibiotics within 48 hours prior to randomization;
  • Have taken probenecid, metoclopramide, methotrexate, aspirin, or other antimicrobial agents within 48 hours prior to dosing;
  • Have taken valproic acid or valproic acid-releasing drugs (including sodium valproate, sodium divalproex, etc.) within 48 hours prior to dosing;
Show all 18Show fewer
  • Previous or current STDs;
  • Previous diabetes mellitus with unregulated treatment showing abnormal blood glucose ;
  • Patients allergic (including lactose intolerance) to penicillins, pivmecillinam, mecillinam, cephalosporins, fosfomycin tromethamine, or other components of the study drug;
  • Patients suspected to be unable to comply with the protocol (e.g., alcoholism, drug dependence, or poor mental status);
  • Patients have been enrolled in this trial;
  • Those who have participated in other drug interventional clinical trials or are participating in other clinical trials within 3 months prior to screening;
  • Patients who have taken study drug within the past 3 months;
  • Pregnant, lactating women, patients who are pregnant during the study or have a fertility plan within 3 months after the end of the trial;
  • Complaints of active gastric ulcer and episodes of hemorrhagic gastritis;
  • Abnormal liver and kidney function tests (ALT, AST ≥ 1.5 times the upper limit of normal, or serum creatinine ≥ 1.5 × upper limit (ULN) or creatinine clearance ≤ 50 mL/min), or other diseases that affect the efficacy of the drug as judged by the investigator ;
  • Those who are judged by the investigator to be ineligible for enrollment by clinical laboratory tests, electrocardiograms, urinary ultrasound, etc.;
  • Other reasons for inappropriate participation in the trial in the opinion of the investigator.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

China10 sites

  • Beijing hospital

    Beijing, Beijing Municipality, 100000

  • Xiangya Humanity Rehabilitation hospital

    Changsha, Hunan, 410000

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510000

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250000

  • Loudi Central Hospital

    Loudi, Hunan, 417000

  • Jiangsu Provincial Hospital of Integrated Chinese and Western Medicine

    Nanjing, Jiangsu, 210000

  • Guangxi Zhuang Autonomous Region People's Hospital

    Nanning, Guangxi, 530000

  • The second hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

  • Wuhan Central Hospital

    Wuhan, Hubei, 430000

  • Yueyang people's Hospital

    Yueyang, Hunan, 414000

Other trials in China

About this study

Official title: Pivmecillinam Hydrochloride Tablets Versus Fosfomycin Tromethamine Granules for Uncomplicated Urinary Tract Infection in Women -A Randomized, Double-blind, Double Simulation, Positive Drug Parallel-controlled, Multi Center Phase III Clinical Trial in China

the purpose of this study is to evaluate the efficacy and safety of pivmecillinam hydrochloride tablets in the treatment of uncomplicated urinary tract infection in China

Read the detailed description

Screening period (D -3 to D -1): complete screening examinations will be performed after the subject signs the informed consent

Dosing Treatment Period (D 1 to D 5): subjects who met the inclusion criteria and did not meet the exclusion criteria were randomized. Refer to the randomization protocol for specific randomization process.

Safety check (D 5+1): perform on-site visit after 15 doses (D 5+1)

Post-treatment follow-up assessments ((D 12±2) and (D 21+7)): subjects returned to the study site for on-site follow-up on Day 12±2 and Day 21+7.

Urine bacterial culture and minimal inhibitory concentration (MIC) test: urine bacterial culture is required for subjects.

Being tested
Pivmecillinam hydrochloride tablets, Fosfomycin Tromethamine Granules

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pivmecillinam hydrochloride tabletsDrug

    Also called Selexid®

    400mg tablet

  • Fosfomycin Tromethamine GranulesDrug

    Also called Monurol®

    3g/pack

Study groups in NCT05545137
Study groupRoleWhat they receive
Pivmecillinam hydrochloride tablets treatment groupExperimentalparticipants received Pivmecillinam Hydrochloride Tablets + Fosfomycin Tromethamine Granules Simulant. Pivmecillinam Hydrochloride Tablets:oral,One tablets each time,3 times a day for five days. Fosfomycin Tromethamine Granules Simulant :oral, 1 pack, only once for the entire course of treatment
Receives: Drug: Pivmecillinam hydrochloride tablets
Fosfomycin Tromethamine Granules treatment groupActive comparatorparticipants received Fosfomycin Tromethamine Granules + Pivmecillinam Hydrochloride Tablets Simulant Fosfomycin Tromethamine Granules:oral, 1 pack, only once for the entire course of treatment. Pivmecillinam Hydrochloride Tablets Simulant :oral,One tablets each time,3 times a day for five days.
Receives: Drug: Fosfomycin Tromethamine Granules

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in urinary tract infection symptom score

    The Urinary Tract Infection Symptom Score is a validated, self-reported tool to assess the severity of frequency, urgency, pain, dysuria, and may range from 0 (no symptoms) to 12 (worst symptoms).

    Change = (Day 12±2 Score - Baseline Score)

    Measured: From Baseline to Day 12±2

  2. Urine white blood cell count

    Defined as whether the subject 's white blood cell count returned to normal. The result was yes or no.

    Measured: Day 12±2

Secondary outcomes (8)

  1. Urine culture pathogen count at visit

    The urine culture pathogenic bacteria count at the visit was defined as: the urine culture pathogen (baseline pathogen) at enrollment was cleared at the visit or the bacterial count was reduced to< 10^3 CFU(Colony-Forming Unit)/ml. The judgment results were: Yes, No, and could not be judged (could not be judged due to lack of culture results).

    Measured: Day 12±2

  2. Change in urinary tract infection symptom score

    The Urinary Tract Infection Symptom Score is a validated, self-reported tool to assess the severity of frequency, urgency, Urinary pain, dysuria, and may range from 0 (no symptoms) to 12 (worst symptoms).

    Change = (Day 12±2 Score - Baseline Score)

    Measured: From Baseline to Day 5+1

  3. Urine white blood cell count

    Defined as whether the subject 's white blood cell count returned to normal. The result was yes or no.

    Measured: Day 5+1

  4. Urine culture pathogen count at visit

    The urine culture pathogenic bacteria count at the visit was defined as: the urine culture pathogen (baseline pathogen) at enrollment was cleared at the visit or the bacterial count was reduced to<10^3 CFU/ml. The judgment results were: Yes, No, and could not be judged (could not be judged due to lack of culture results).

    Measured: Day 5+1

  5. Change in urinary tract infection symptom score

    The Urinary Tract Infection Symptom Score is a validated, self-reported tool to assess the severity of frequency, urgency, Urinary pain, dysuria, and may range from 0 (no symptoms) to 12 (worst symptoms).

    Change = (Day 12±2 Score - Baseline Score)

    Measured: From Baseline to Day 21+7

  6. Urine white blood cell count

    Defined as whether the subject 's white blood cell count returned to normal. The result was yes or no.

    Measured: Day 21+7

  7. Urine culture pathogen count at visit

    The urine culture pathogenic bacteria count at the visit was defined as: the urine culture pathogen (baseline pathogen) at enrollment was cleared at the visit or the bacterial count was reduced to<10^3 CFU/ml. The judgment results were: Yes, No, and could not be judged (could not be judged due to lack of culture results).

    Measured: Day 21+7

  8. Safety variables

    Safety variables: adverse events reported by the patient at the visit or occurred during the trial.

    Measured: Day 5+1,Day 12±2,Day 21+7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2022
  2. Study start29 Sep 2022
  3. Primary completion5 Feb 2024
  4. Study completion20 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
299 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05545137
Sponsor's protocol ID
CS1046
Status last verified
Apr 2024
First submitted
2 Sep 2022
Last updated
17 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pivmecillinam hydrochloride tablets and Fosfomycin Tromethamine Granules in people with Uncomplicated Urinary Tract Infection, run by Benova (Tianjin) Innovative medicine Research Co., Ltd. at 10 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in urinary tract infection symptom score (time frame: From Baseline to Day 12±2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05545137.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.

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