Intra-abdominal InfectionsPhase 3NCT06633718
Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in CIAI
A Phase 3 study testing Meropenem and Pralurbactam, Saline and Ceftazidime-avibactam in people with Intra-abdominal Infections, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a Phase 3, randomized, double-blind, multicenter, positive control study to assess the efficacy, safety, and pharmacokinetics of Meropenem and Pralurbactam compared with Ceftazidime-avibactam in combination with Metronidazole in the treatment of adult complicated intra-abdominal infections (cIAI). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intra-abdominal Infections
- What is being tested?
- Meropenem and Pralurbactam, Saline and Ceftazidime-avibactam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 786 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2024to 30 May 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 participants ≥18 and ≤75 years of age.
- Diagnosed or highly suspected cIAI.
- Evidence of a systemic inflammatory response with at least one of the following:a. Fever ( temperature ≥ 38°C); b. hypotension (systolic blood pressure < 90 mmhg); c. abdominal pain; d. nausea and/or vomiting; e. physical examination found abdominal mass; f. mental state change; g. other circumstances.
- Female subjects must meet the following conditions: a. menopause for at least 1 year, or b. Sterilization has been performed, or C. Those who are fertile must meet the following conditions at the same time: the random pre-blood/urine pregnancy test is negative, effective contraceptive measures are taken during the study period and within 30 days after the last application of experimental drugs, and eggs are not donated, and they are not breastfeeding.
- Male subjects are willing to take effective contraceptive measures and not donate sperm during the study period and within 30 days after the last application of experimental drugs.
- Understand and abide by the research procedures and methods, voluntarily participate in this research, and sign an informed consent form .
Who cannot join
- Allergic to any carbapenem, cephalosporin, penicillin, metronidazole disodium phosphate, other beta-lactam drugs or other beta-lactamase inhibitors and their auxiliary materials.
- Non-complicated abdominal infection (infection is limited to abdominal organs), such as simple appendicitis and simple cholecystitis.
- Abdominal wall infection or abscess (infection has not spread into abdominal cavity).
- The creatinine clearance rate in the screening period is ≤50mL/min.
- The estimated survival time is less than 4 weeks.
- Those who have a history of drug abuse or drug abuse within 6 months before screening.
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- Those who participated in other clinical trials within 28 days before randomization and used any test drugs or medical devices.
- Any physiological or psychological disease or condition that may increase the risk of the experiment, affect the compliance of the subject with the protocol or affect the completion of the experiment as judged by the researcher.
- Subjects are directly related persons who participated in this research.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014
Tingwei Liang, +86-18560013055, tingwei.liang@qilu-pharma.com
About this study
Official title: A Phase 3,Multicenter, Randomized, Double-Blind, Positive Control，Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in Complicated Intra-abdominal Infections
This is a Phase 3, randomized, double-blind, multicenter, positive control study to assess the efficacy, safety, and pharmacokinetics of Meropenem and Pralurbactam compared with Ceftazidime-avibactam in combination with Metronidazole in the treatment of adult complicated intra-abdominal infections (cIAI).
Read the detailed description
This is a Phase 3, randomized, double-blind, multicenter, positive control study to assess the efficacy, safety, and pharmacokinetics of Meropenem and Pralurbactam compared with Ceftazidime-avibactam in combination with Metronidazole in the treatment of adult complicated intra-abdominal infections (cIAI). Treatment duration for each cohort was 7 to 14 days.
- Conditions
- Intra-abdominal Infections
- Being tested
- Meropenem and Pralurbactam, Saline, Ceftazidime-avibactam, Metronidazole
- Medical subject headings
- Intraabdominal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meropenem and PralurbactamDrug
3g，q8h，120min infusion
SalineDrug
100mL，q8h，60min infusion
Ceftazidime-avibactamDrug
2.5g，q8h，120min infusion
MetronidazoleDrug
0.915g，q8h，60min infusion
| Study group | Role | What they receive |
|---|---|---|
| Meropenem and Pralurbactam | Experimental | Meropenem and Pralurbactam (120min infusion) Receives: Drug: Meropenem and Pralurbactam; Drug: Saline |
| Ceftazidime-avibactam | Active comparator | Ceftazidime-avibactam (120min infusion) 、 Metronidazole(60min infusion) Receives: Drug: Ceftazidime-avibactam; Drug: Metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With a Clinical Response of "Cure" at the Test of Cure (TOC) Visit
Percentage of Participants With a Clinical Response of "Cure" at the Test of Cure (TOC) Visit
Measured: Up to approximately 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start31 Oct 2024 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-abdominal InfectionsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 786 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yunfei Ju, MM, Study chair, Qilu Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633718
- Sponsor's protocol ID
- FL058-301
- Status last verified
- Sep 2024
- First submitted
- 26 Sep 2024
- Last updated
- 9 Oct 2024
- 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 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3,Multicenter, Randomized, Double-Blind, Positive Control，Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in Complicated Intra-abdominal Infections
- ClinicalTrials.gov ID
- NCT06633718
- Acronym / sponsor ID
- FL058-301
- Conditions
- Intra-abdominal Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 786 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2024 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 9 Oct 2024 (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.
This is a Phase 3, randomized, double-blind, multicenter, positive control study to assess the efficacy, safety, and pharmacokinetics of Meropenem and Pralurbactam compared with Ceftazidime-avibactam in combination with Metronidazole in the treatment of adult complicated intra-abdominal infections (cIAI).
Detailed description
This is a Phase 3, randomized, double-blind, multicenter, positive control study to assess the efficacy, safety, and pharmacokinetics of Meropenem and Pralurbactam compared with Ceftazidime-avibactam in combination with Metronidazole in the treatment of adult complicated intra-abdominal infections (cIAI). Treatment duration for each cohort was 7 to 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meropenem and Pralurbactam | Experimental | Drug: Meropenem and Pralurbactam, Drug: SalineMeropenem and Pralurbactam (120min infusion) |
| Ceftazidime-avibactam | Active comparator | Drug: Ceftazidime-avibactam, Drug: MetronidazoleCeftazidime-avibactam (120min infusion) 、 Metronidazole(60min infusion) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female participants ≥18 and ≤75 years of age.
- Diagnosed or highly suspected cIAI.
- Evidence of a systemic inflammatory response with at least one of the following:a. Fever ( temperature ≥ 38°C); b. hypotension (systolic blood pressure < 90 mmhg); c. abdominal pain; d. nausea and/or vomiting; e. physical examination found abdominal mass; f. mental state change; g. other circumstances.
- Female subjects must meet the following conditions: a. menopause for at least 1 year, or b. Sterilization has been performed, or C. Those who are fertile must meet the following conditions at the same time: the random pre-blood/urine pregnancy test is negative, effective contraceptive measures are taken during the study period and within 30 days after the last application of experimental drugs, and eggs are not donated, and they are not breastfeeding.
- Male subjects are willing to take effective contraceptive measures and not donate sperm during the study period and within 30 days after the last application of experimental drugs.
Key exclusion criteria (9 listed)
- Allergic to any carbapenem, cephalosporin, penicillin, metronidazole disodium phosphate, other beta-lactam drugs or other beta-lactamase inhibitors and their auxiliary materials.
- Non-complicated abdominal infection (infection is limited to abdominal organs), such as simple appendicitis and simple cholecystitis.
- Abdominal wall infection or abscess (infection has not spread into abdominal cavity).
- The creatinine clearance rate in the screening period is ≤50mL/min.
- The estimated survival time is less than 4 weeks.
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 and Pralurbactam3g，q8h，120min infusion | Drug | Meropenem and Pralurbactam |
| Saline100mL，q8h，60min infusion | Drug | Meropenem and Pralurbactam |
| Ceftazidime-avibactam2.5g，q8h，120min infusion | Drug | Ceftazidime-avibactam |
| Metronidazole0.915g，q8h，60min infusion | Drug | Ceftazidime-avibactam |
Primary outcome
Percentage of Participants With a Clinical Response of "Cure" at the Test of Cure (TOC) Visit
Time frame: Up to approximately 28 days
Percentage of Participants With a Clinical Response of "Cure" at the Test of Cure (TOC) Visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
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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.
Yunfei Ju, MM study chair
Qilu Pharmaceutical Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Meropenem and Pralurbactam, Saline and Ceftazidime-avibactam in people with Intra-abdominal Infections, run by Qilu Pharmaceutical Co., 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 6 inclusion and 9 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: opening soon, as of the sponsor's last update on 9 Oct 2024. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yunsong Yu, Professor (+86-0571-85893267, yvys119@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With a Clinical Response of "Cure" at the Test of Cure (TOC) Visit (time frame: Up to approximately 28 days). 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 9 Oct 2024.