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

Acute Pyelonephritis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05060419
• Other study ID #: FL058-II-01
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 8, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: September 2021
• Source: Qilu Pharmaceutical Co., Ltd.
• Contact: Ju Yunfei, MM
• Phone: +86-0531-55821309
• Email: yunfei.ju[@]qilu-pharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: August 31, 2022
• Est. primary completion date: April 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Male or female patients, aged 18 ~ 75 years (inclusive);;

2. Acute pyelonephritis or other complicated urinary tract infection.

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 ß -lactam drugs or other ß -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.

Related Conditions & MeSH terms

• Acute Pyelonephritis
• Communicable Diseases
• Complicated Urinary Tract Infection
• Infections
• Pyelonephritis
• Urinary Tract Infections

Intervention

Drug:
• Meropenem- FL058
Meropenem-FL058(Meropenem 1000mg plus FL058 1000mg)q8h Meropenem-FL058(Meropenem 2000mg plus FL058 1000mg)q8h
• Piperacillin -tazobactam
Piperacillin-tazobactam (piperacillin 4 g plus tazobactam 0.5 g)q8h
• Saline
180min
• Saline
30min

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 to 9 days post-End of Treatment