Complicated Urinary Tract InfectionPhase 2NCT05060419
Meropenem-FL058 Phase 2 Study in the Treatment of Complicated Urinary Tract Infections
A Phase 2 study testing Meropenem- FL058, Piperacillin -tazobactam and Saline in people with Complicated Urinary Tract Infection and Acute Pyelonephritis, run by Qilu Pharmaceutical Co., Ltd..
Trial summary
Phase 2, randomised, double-blind,double-dummy study in hospitalised adults with complicated urinary tract infection (cUTI), including acute pyelonephritis.Treatment duration for each cohort was 7 to 14 days. Patients were not permitted to switch to oral therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Complicated Urinary Tract Infection, Acute Pyelonephritis
- What is being tested?
- Meropenem- FL058, Piperacillin -tazobactam and Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 8 Oct 2021to 31 Aug 2022
- Phase
- Phase 2
- 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 or female patients, aged 18 ~ 75 years (inclusive);；
- Acute pyelonephritis or other complicated urinary tract infection.
Who cannot join
- Patients needing concomitant systemic antimicrobial agents in addition to those designated in the various study treatment groups;
- Fungal urinary tract infection;
- History of allergic to any carbapenem, cephalosporin, penicillin, other β -lactam drugs or other β -lactamase inhibitors;
- Pregnant or breastfeeding women;
- Inability to tolerate intravenous fluids, due to medical reasons, of 1050 mL per day required for study drug administration;
- Unable or unwilling, in the judgment of the Investigator, to comply with the protocol.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Phase Ⅱ, Randomized, Double-Blind,Double-Dummy Study Evaluating Safety,Tolerability,Efficacy of Meropenem-FL058 in Adult Patients With Complicated Urinary Tract Infections, Including Acute Pyelonephritis
Phase 2, randomised, double-blind,double-dummy study in hospitalised adults with complicated urinary tract infection (cUTI), including acute pyelonephritis.Treatment duration for each cohort was 7 to 14 days. Patients were not permitted to switch to oral therapy.
- Being tested
- Meropenem- FL058, Piperacillin -tazobactam, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meropenem- FL058Drug
Meropenem-FL058(Meropenem 1000mg plus FL058 1000mg)q8h
Meropenem-FL058(Meropenem 2000mg plus FL058 1000mg)q8h
Piperacillin -tazobactamDrug
Piperacillin-tazobactam (piperacillin 4 g plus tazobactam 0.5 g)q8h
SalineDrug
180min
SalineDrug
30min
| Study group | Role | What they receive |
|---|---|---|
| Meropenem-FL058 (180min infusion) | Experimental | Not described Receives: Drug: Meropenem- FL058; Drug: Saline |
| Piperacillin-Tazobactan (30min infusion) | Active comparator | Not described Receives: Drug: Piperacillin -tazobactam; Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients in the Microbiological Modified Intent to Treat (m-MITT) Population who achieve overall treatment success at Test Of Cure (TOC).
Treatment success is defined as the composite of clinical outcome of Cure and the microbiological outcome of Eradication.
Measured: 5 to 9 days post-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 posted29 Sep 2021
- Study start8 Oct 2021 (estimated)
- Primary completion29 Apr 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complicated Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huang Haihui, Professor, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060419
- Sponsor's protocol ID
- FL058-II-01
- Status last verified
- Sep 2021
- First submitted
- 18 Sep 2021
- Last updated
- 29 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ⅱ, Randomized, Double-Blind,Double-Dummy Study Evaluating Safety,Tolerability,Efficacy of Meropenem-FL058 in Adult Patients With Complicated Urinary Tract Infections, Including Acute Pyelonephritis
- ClinicalTrials.gov ID
- NCT05060419
- Acronym / sponsor ID
- FL058-II-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Oct 2021 (estimated)
- Primary completion
- 29 Apr 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 29 Sep 2021 (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.
Phase 2, randomised, double-blind,double-dummy study in hospitalised adults with complicated urinary tract infection (cUTI), including acute pyelonephritis.Treatment duration for each cohort was 7 to 14 days. Patients were not permitted to switch to oral therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meropenem-FL058 (180min infusion) | Experimental | Drug: Meropenem- FL058, Drug: Saline |
| Piperacillin-Tazobactan (30min infusion) | Active comparator | Drug: Piperacillin -tazobactam, Drug: Saline |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female patients, aged 18 ~ 75 years (inclusive);；
- Acute pyelonephritis or other complicated urinary tract infection.
Key exclusion criteria (6 listed)
- Patients needing concomitant systemic antimicrobial agents in addition to those designated in the various study treatment groups;
- Fungal urinary tract infection;
- History of allergic to any carbapenem, cephalosporin, penicillin, other β -lactam drugs or other β -lactamase inhibitors;
- Pregnant or breastfeeding women;
- Inability to tolerate intravenous fluids, due to medical reasons, of 1050 mL per day required for study drug administration;
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 |
|---|---|---|
| Meropenem- FL058Meropenem-FL058(Meropenem 1000mg plus FL058 1000mg)q8h Meropenem-FL058(Meropenem 2000mg plus FL058 1000mg)q8h | Drug | Meropenem-FL058 (180min infusion) |
| Piperacillin -tazobactamPiperacillin-tazobactam (piperacillin 4 g plus tazobactam 0.5 g)q8h | Drug | Piperacillin-Tazobactan (30min infusion) |
| Saline180min | Drug | Piperacillin-Tazobactan (30min infusion) |
| Saline30min | Drug | Meropenem-FL058 (180min infusion) |
Primary outcome
Proportion of patients in the Microbiological Modified Intent to Treat (m-MITT) Population who achieve overall treatment success at Test Of Cure (TOC).
Time frame: 5 to 9 days post-End of Treatment
Treatment success is defined as the composite of clinical outcome of Cure and the microbiological outcome of Eradication.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
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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.
Huang Haihui, Professor principal investigator
Huashan Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Meropenem- FL058, Piperacillin -tazobactam and Saline in people with Complicated Urinary Tract Infection and Acute Pyelonephritis, run by Qilu Pharmaceutical Co., Ltd..
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ju Yunfei, MM (+86-0531-55821309, yunfei.ju@qilu-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients in the Microbiological Modified Intent to Treat (m-MITT) Population who achieve overall treatment success at Test Of Cure (TOC). (time frame: 5 to 9 days post-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 29 Sep 2021.