Complicated Urinary Tract Infection Including Acute PyelonephritisPhase 2/3NCT04505683
A Study to Assess Efficacy and Safety Intravenous Benapenem in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
A Phase 2/3 study testing Benapenem and Ertapenem in people with Complicated Urinary Tract Infection Including Acute Pyelonephritis, run by Sihuan Pharmaceutical Holdings Group Ltd. at 1 site in China.
Trial summary
A Study to Assess Efficacy and Safety Intravenous Benapenem in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Complicated Urinary Tract Infection Including Acute Pyelonephritis
- What is being tested?
- Benapenem and Ertapenem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- 13 Dec 2018to 8 May 2020
- Phase
- Phase 2/3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects aged 18-75 years
- Have a diagnosis of cUTI or AP as defined below:
- cUTI definition:
- At least Two of the following signs and symptoms:
- Chills, rigors, or fever; fever must be observed and documented by a health care provider (tympanic temperature ≥37.3°C)
- Flank pain or Lower abdominal pain
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- Dysuria, urgency to void, or increased urinary frequency
- Nausea or vomiting
- Costovertebral angle tenderness or renal percussive pain on physical examination.
- Blood leukocytes above upper limit of normal value
- And at least One of the following risk factors for cUTI:
- Implanted urinary tract instrumentation (e.g., nephrostomy tube, ureteric stents), ongoing intermittent bladder catheterization, or presence of an indwelling bladder catheter (Note: bladder catheters prior to Screening should be expected to remove during study period
- post-void residual urine volume of ≥ 100 mL;
- Obstructive uropathy (e.g. bladder outlet obstruction, nephrolithiasis, prostatic hyperplasia) that is expected to be removed during study drug therapy;
- Perioperative urinary tract infection.
- AP definition: And at least One of the following signs and symptoms:
- Chills, rigors, or fever; fever must be observed and documented by a health care provider (tympanic temperature ≥37.3°C）；
- Flank pain
- Dysuria, urgency to void, or increased urinary frequency
- Nausea or vomiting
- Costovertebral angle tenderness or renal percussive pain on physical examination.
- Blood leukocytes above upper limit of normal value
- Patients or legal representatives can be able to provide informed consent
Who cannot join
- Receipt of potentially effective antibiotic therapy more than 24h within 72 h prior to randomization
- Anticipated concomitant use of other systemic antibiotic drugs during the study period
- Anticipated continnue to preventive anti-infectious therapy after cUTI patients completed investigational drug treatment
- Presence of any known or suspected disease or condition as following:
- Uncomplicated urinary tract infection (uUTI)
- Fungal Urinary tract infection
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- Perinephric or renal corticomedullary abscess
- Polycystic kidney disease
- Urinary tuberculosis
- Obstructive uropathy(e.g.congenital malformation) unable to remove during treatment.
- Ideal loop surgery or vesicoureteral reflux
- Permannent bladder catheterization or long term indwelling nephrostomy tube
- Previous or planned renal transplantation
- Patients undergoing dialysis"
- Confirmed or suspected acute or chronic bacterial prostatitis, orchitis, or epididymitis
- Confirmed or suspected sexually transmitted disease,e.g. gonorrhea and syphilis
- Confirmed or suspected non-renal source of infection (e.g., infective endocarditis, osteomyelitis, meningitis, pneumonia)
- Trauma to the pelvis or urinary tract within 7days before enrollment
- Rapid onset or life-threatening diseases, such as septic shock, respiratory failure, sepsis, etc;
- Severe cardiovascular and cerebrovascular diseases, acute myocardial infarction, acute ischemic stroke, acute Hemorrhagic stroke or intravascular intervention within recently 3 months
- Known or suspected central nerve system disorders, prone to epilepsy(e.g severe carebral arteriosclerosis)
- Known history of immunodeficiency diease, e.g.AIDS or human immunodeficiency virus (HIV) infection,hematologic malignancy, bone marrow transplant, or receiving immunosuppressive therapy such as cancer chemotherapy, medications for the rejection of transplantation, and long term use of systemic corticosteroids;
- Use of valproic acid or probenecid within 30 days before enrollment or during study period.
- Hepatic impairment at Screening, evidenced as:
- alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3x upper limit of normal (ULN);
- total bilirubin >1.5x ULN;
- alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2x upper limit of normal (ULN) and total bilirubin > ULN; Creatinine clearance (CrCl) of <60 mL/min, as estimated by the Cockcroft-Gault formula: estimated Creatinine Clearance (eC_Cr) [mL/min]=((140-Age [yrs]) × Body Weight [kg] × [0.85 if Female])/(72 × Serum Creatinine [mg⁄dL])
- Known allergic to β-lactam drugs or in an allergic state
- Confirmed or suspected alcohol or drug abuse history
- Patients with other mental disorders who are unable or unwilling to cooperate.
- Pregnant or breastfeeding women or plan to pregnant and unwilling to take contraceptive methods
- Participants in other clinical trials within 3 months before enrollment.
- Other situations that the investigators considers not suitable to participate in this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
Official title: A Phase 2, Randomized, Double-blind, Positive-control, Multicenter, Prospective Study to Assess Efficacy and Safety of Intravenous Benapenem in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
A Study to Assess Efficacy and Safety Intravenous Benapenem in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
- Being tested
- Benapenem, Ertapenem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BenapenemDrug
Benapenem for IV injection administered as a 1-gram IV infusion
ErtapenemDrug
Ertapenem for IV injection administered as a 1-gram IV infusion
| Study group | Role | What they receive |
|---|---|---|
| test drug arm | Experimental | Benapenem for IV injection administered as a 1-gram IV infusion over 30 min once daily for 7 to 14 days. Receives: Drug: Benapenem |
| active control arm | Active comparator | Ertapenem for IV injection administered as a 1-gram IV infusion over 30 min once daily for 7 to 14 days. Receives: Drug: Ertapenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with clinical cure at test-of-cure (TOC) visit
Clinical cure is defined as complete resolution of signs,symptoms and related laboratory tests of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted.
Measured: Day 7 +/- 1 days after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start13 Dec 2018
- Primary completion8 May 2020
- Study completion8 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complicated Urinary Tract Infection Including Acute PyelonephritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sihuan Pharmaceutical Holdings Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505683
- Sponsor's protocol ID
- 5081-II-2001
- Status last verified
- Aug 2020
- First submitted
- 6 Aug 2020
- Last updated
- 10 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Positive-control, Multicenter, Prospective Study to Assess Efficacy and Safety of Intravenous Benapenem in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
- ClinicalTrials.gov ID
- NCT04505683
- Acronym / sponsor ID
- 5081-II-2001
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Sihuan Pharmaceutical Holdings Group Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Dec 2018 (actual)
- Primary completion
- 8 May 2020 (actual)
- Study completion
- 8 May 2020 (actual)
- First posted
- 10 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Study to Assess Efficacy and Safety Intravenous Benapenem in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test drug arm | Experimental | Drug: BenapenemBenapenem for IV injection administered as a 1-gram IV infusion over 30 min once daily for 7 to 14 days. |
| active control arm | Active comparator | Drug: ErtapenemErtapenem for IV injection administered as a 1-gram IV infusion over 30 min once daily for 7 to 14 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Male and female subjects aged 18-75 years
- Have a diagnosis of cUTI or AP as defined below:
- Patients or legal representatives can be able to provide informed consent
Key exclusion criteria (33 listed)
- Receipt of potentially effective antibiotic therapy more than 24h within 72 h prior to randomization
- Anticipated concomitant use of other systemic antibiotic drugs during the study period
- Anticipated continnue to preventive anti-infectious therapy after cUTI patients completed investigational drug treatment
- Presence of any known or suspected disease or condition as following:
- Confirmed or suspected acute or chronic bacterial prostatitis, orchitis, or epididymitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BenapenemBenapenem for IV injection administered as a 1-gram IV infusion | Drug | test drug arm |
| ErtapenemErtapenem for IV injection administered as a 1-gram IV infusion | Drug | active control arm |
Primary outcome
Percentage of patients with clinical cure at test-of-cure (TOC) visit
Time frame: Day 7 +/- 1 days after the end of treatment
Clinical cure is defined as complete resolution of signs,symptoms and related laboratory tests of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Benapenem and Ertapenem in people with Complicated Urinary Tract Infection Including Acute Pyelonephritis, run by Sihuan Pharmaceutical Holdings Group Ltd. at 1 site 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 23 inclusion and 33 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 10 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Percentage of patients with clinical cure at test-of-cure (TOC) visit (time frame: Day 7 +/- 1 days after the end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2020.