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Status unknownNCT05060419Updated Sep 29, 2021

Meropenem-FL058 Phase 2 Study in the Treatment of Complicated Urinary Tract Infections

A Phase 2 interventional study of Meropenem- FL058 and Piperacillin -tazobactam in Complicated Urinary Tract Infection and Acute Pyelonephritis, sponsored by Qilu Pharmaceutical Co., Ltd.. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-09-29.

Sponsored by Qilu Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Complicated Urinary Tract Infection
  • Acute Pyelonephritis
03

In context

Pyelonephritis

79 studies on the registry are indexed under Pyelonephritis; 12 are open to participants now.

This study's planned enrollment of 150 is below the median of 175 across 62 interventional studies indexed under Pyelonephritis.

Browse Pyelonephritis studies →

Lead sponsor

Qilu Pharmaceutical Co., Ltd. is the lead sponsor of 198 studies on the registry; 120 are open to participants now.

Browse Qilu Pharmaceutical Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female patients, aged 18 \~ 75 years (inclusive);；
  2. Acute pyelonephritis or other complicated urinary tract infection.

Exclusion criteria

Exclusion Criteria:

  1. Patients needing concomitant systemic antimicrobial agents in addition to those designated in the various study treatment groups;
  2. Fungal urinary tract infection;
  3. History of allergic to any carbapenem, cephalosporin, penicillin, other β -lactam drugs or other β -lactamase inhibitors;
  4. Pregnant or breastfeeding women;
  5. Inability to tolerate intravenous fluids, due to medical reasons, of 1050 mL per day required for study drug administration;
  6. Unable or unwilling, in the judgment of the Investigator, to comply with the protocol.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Meropenem-FL058 (180min infusion)

    Drug: Meropenem- FL058 · Drug: Saline

  • Active comparator
    Piperacillin-Tazobactan (30min infusion)

    Drug: Piperacillin -tazobactam · Drug: Saline

Interventions

  • DrugMeropenem- FL058

    Meropenem-FL058(Meropenem 1000mg plus FL058 1000mg)q8h Meropenem-FL058(Meropenem 2000mg plus FL058 1000mg)q8h

  • DrugPiperacillin -tazobactam

    Piperacillin-tazobactam (piperacillin 4 g plus tazobactam 0.5 g)q8h

  • DrugSaline

    180min

  • DrugSaline

    30min

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 5 to 9 days post-End of Treatment

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05060419
Lead sponsor
Qilu Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Sep 29, 2021
Start date
Oct 8, 2021 (estimated)
Primary completion
Apr 29, 2022 (estimated)
Completion
Aug 31, 2022 (estimated)
Last update
Sep 29, 2021

Study contacts

Ju Yunfei, MM
Contact
yunfei.ju@qilu-pharma.com
+86-0531-55821309
Huang Haihui, Professor
principal investigator · Huashan Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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