An Efficacy and Safety of Flomoxef Versus Cefepime in the Treatment of Participants With Urinary Tract Infections

NCT02302092 | Terminated Phase 3 Results

• 2 other identifiers: FLOMOXEF_301U1111-1154-2448
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to compare the effectiveness of antibiotic flomoxef with cefepime for the treatment of complicated urinary tract infections (cUTIs) in Russian adults.

Conditions

Urinary Tract Infection

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved Resolution of All Clinical Symptoms of a Complicated Urinary Tract Infection (cUTI) at the End of Treatment (EOT) Visit

  At the EOT visit (Days 7 to 14), the Investigator collected information about each symptom and performed a judgement about the participant's status. Clinical symptoms present at trial entry were considered to be resolved if the participant has no pyuria; no fever; no malaise, flank pain, back pain, and/or costo-vertebral angle pain or tenderness; and no symptoms of dysuria, urinary urgency, urinary frequency, suprapubic discomfort, new urinary incontinence, or worsening of pre-existing incontinence. Resolution of all clinical symptoms of cUTI were assessed relative to baseline.

  Baseline and Days 7 to 14

Secondary Outcomes (10)

• Percentage of Participants With Microbiological Success at the EOT and Test-of-Cure (TOC) Visits

  Baseline, Days 7 to 14 and 14 to 21

• Percentage of Participants Who Achieved Clinical Resolution of Symptoms of a cUTI at Visit 3, TOC and Late Follow-up (LFU) Visits

  Baseline, Days 3, 14 to 21 and 30

• Percentage of Participants With Microbiologic Eradication of the Unique Pathogen at the EOT and TOC Visits

  Baseline, Days 7 to 14 and 14 to 21

• Percentage of Participants With Microbiologic Persistence of the Unique Pathogen at the EOT and TOC Visits

  Baseline, Days 7 to 14 and 14 to 21

• Percentage of Participants With a New Infection at the EOT and TOC Visits

  Baseline, Days 7 to 14 and 14 to 21

Study Arms (2)

Flomoxef

EXPERIMENTAL

Flomoxef, 2g, injection, intravenously, twice daily (every 12 hours), for up to 12 days.

Drug: Flomoxef

Cefepime

ACTIVE COMPARATOR

Cefepime, 1g, injection, intravenously, twice daily (every 12 hours) for up to 14 days.

Drug: Cefepime

Interventions

Flomoxef DRUG

Flomoxef intravenous infusion

Flomoxef

Cefepime DRUG

Cefepime intravenous infusion

Also known as: Maxipime

Cefepime

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is a man or woman aged 18 to 70 years, inclusive.
• Has pyuria (a white blood cell \[WBC\] count greater than 10/μL in unspun urine or greater than or equal to 10 per high power field in spun urine).
• Has clinical signs and/or symptoms of a complicated lower urinary tract infection (UTI) and/or acute pyelonephritis that include one or more of the following: fever (i.e, axillary temperature greater than 37.7°C), chills, malaise, flank pain, back pain, and/or costo-vertebral angle pain or tenderness and/or any symptoms of dysuria (dysuria, urinary urgency, urinary frequency, suprapubic discomfort, new urinary incontinence or worsening of pre-existing incontinence) that occur in the presence of a functional or anatomical abnormality of the urinary tract or in the presence of catheterization.
• Has a pretreatment baseline urine culture specimen obtained within 24 hours before the administration of the first dose of study drug (NOTE: Participants may be enrolled in this study and start intravenous (IV) study drug therapy before the Investigator knows the results of the baseline urine culture).
• Requires IV antibacterial therapy for the treatment of the presumed complicated UTI (cUTI).
• In the opinion of the investigator, is capable of understanding and complying with protocol requirements.
• Signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures, or has a legally acceptable representative sign the forms.
• Meets protocol-specified criteria regarding the use of contraception; and 9-Is willing and able to comply with study procedures.

You may not qualify if:

• Has received any investigational compound within 30 days of screening.
• Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, or sibling) or may consent under duress.
• Is a female participant who is pregnant or lactating or intending to become pregnant before, during, or within one month after participating in this study, or intends to donate ova during such time period.
• Is a male participant who intends to donate sperm during the course of this study or for 12 weeks thereafter.
• Has participated in another clinical study within the past 30 days.
• Has a history of allergy to or intolerance of beta-lactams (penicillins, cephalosporins or carbopenems).
• Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1) the safety or well-being of the participant or study staff, 2) the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding), or 3) the analysis of results.
• Has received any amount of potentially therapeutic antibacterial therapy after collection of the pretreatment baseline urine culture and before administration of the first dose of study drug.
• Has received any dose of a potentially therapeutic antibacterial agent for the treatment of the current UTI within 48 hours before providing the pretreatment baseline urine culture specimen.
• Has a current urinary catheter that is not scheduled to be removed before the End-of-Therapy (EOT) visit (intermittent straight catheterization during the IV study drug administration period is acceptable).
• Has any history of trauma to the pelvis or urinary tract within one year before the screening visit.
• Has any other contraindications to the medicines that are to be used in the study (according to the manufacturer's instructions).
• Is considered unlikely to survive the four-week study period or has any rapidly progressing disease or immediately life-threatening illness (including acute hepatic failure, respiratory failure or septic shock).

Sponsors & Collaborators

• Takeda: lead

Study Sites (5)

Unknown Facility

Moscow, Russia

Location

Unknown Facility

Rostov-on-Don, Russia

Location

Unknown Facility

Saint Petersburg, Russia

Location

Unknown Facility

Volgograd, Russia

Location

Unknown Facility

Yaroslavl, Russia

Location

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

flomoxef; Cefepime

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

The study is limited as only 13 out of the original 80 participants planned entered the study, due to this none of the planned statistical analyses from the protocol could be carried out, and all results should be reviewed with caution.

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: November 26, 2014
• Study Start: December 1, 2015
• Primary Completion: February 2, 2016
• Study Completion: December 15, 2016
• Last Updated: October 27, 2017
• Results First Posted: October 27, 2017

Record last verified: 2017-06

Locations

RU (5)