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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-08

Study Completion Date

2022-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Complicated Urinary Tract Infection Acute Pyelonephritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Double-Blind,Double-Dummy

Study Groups

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Meropenem-FL058 (180min infusion)

Group Type EXPERIMENTAL

Meropenem- FL058

Intervention Type DRUG

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

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

Saline

Intervention Type DRUG

30min

Piperacillin-Tazobactan (30min infusion)

Group Type ACTIVE_COMPARATOR

Piperacillin -tazobactam

Intervention Type DRUG

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

Saline

Intervention Type DRUG

180min

Interventions

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Meropenem- FL058

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

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

Intervention Type DRUG

Piperacillin -tazobactam

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

Intervention Type DRUG

Saline

180min

Intervention Type DRUG

Saline

30min

Intervention Type DRUG

Eligibility Criteria

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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 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No