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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00921024 |
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Date of registration:
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12/06/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety and Efficacy of IV CXA-101 and IV Ceftazidime in Patients With Complicated Urinary Tract Infections
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Scientific title:
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A Multicenter, Double-blind, Randomized, Phase 2 Study to Compare the Safety and Efficacy of Intravenous CXA-101 and Intravenous Ceftazidime in Complicated Urinary Tract Infection, Including Pyelonephritis |
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Date of first enrolment:
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June 30, 2009 |
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Target sample size:
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129 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00921024 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Germany
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Poland
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United States
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Contacts
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Name:
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Florian Wagenlehner, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Uniklinikum Giessen |
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Name:
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Ryszard Gellert, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Szpital Bielanski im.Ks. Jerzego Popieluszki Samodzielny Publiczny Zaklad Opieki Zdrowotnej IV Kliniczny Oddzial Chorób Wewnetrznych i Pododdzial Nefrologiczny |
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Name:
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Ahmad Haidar, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mississippi Medical Research, LLC |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Males and females 18 to 90 years of age, inclusive.
2. Pyuria (white blood cell [WBC] count > 10/µL in unspun urine or = 10 per high power
field in spun urine)
3. Clinical signs and/or symptoms of cUTI, either of:
a. Pyelonephritis, as indicated by both of the following: i. Fever (oral temperature =
37.8°C); ii. Flank pain or costovertebral angle tenderness;
OR
b. Complicated lower UTI, as indicated by both of the following: i. At least one of the
following new or worsening symptoms:
- Dysuria;
- Frequency;
- Suprapubic pain;
- Urgency
ii. At least one of the following complicating factors:
- Male gender;
- Current bladder instrumentation or indwelling urinary catheter that is expected to be
removed during the course of IV study drug administration;
- Obstructive uropathy that is expected to be medically or surgically treated during the
course of IV study drug administration;
- Urogenital surgery within 7 days preceding administration of the first dose of study
drug;
- Functional or anatomical abnormality of the urogenital tract including anatomic
malformations or neurogenic bladder with voiding disturbance of at least 100 mL
residual urine.
Exclusion Criteria
1. Documented history of any hypersensitivity or allergic reaction to any ß-lactam
antibacterial
2. Concomitant infection requiring systemic antibacterial therapy in addition to IV study
drug therapy at the time of randomization. Drugs with only gram-positive activity
(e.g. vancomycin, linezolid) are allowed
3. Complete, permanent obstruction of the urinary tract
4. Confirmed (at time of randomization) fungal urinary tract infection (with = 103 fungal
CFU/mL)
5. Suspected or confirmed perinephric or intrarenal abscess
6. Suspected or confirmed prostatitis
7. Known ileal loop or vesico-ureteral reflux
8. Women who are pregnant or nursing
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Complicated Urinary Tract Infection
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Intervention(s)
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Drug: CXA-101
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Drug: Ceftazidime
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Primary Outcome(s)
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Microbiological Response at the TOC Visit in the Microbiologically Evaluable (ME) Population.
[Time Frame: TOC; 6-9 days after last study drug administration]
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Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-Treat (mMITT) Population
[Time Frame: TOC; 6-9 days after last study drug administration]
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Secondary ID(s)
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7625-001
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CXA 101-03
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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