Urinary Tract Infection

  • STATUS
    Recruiting
Updated on 11 February 2021
urinary tract infection
nitrite
dysuria
cystitis
urinary tract infection (uti)
urinary tract infections
acute cystitis

Summary

The purpose of this clinical research study is to evaluate an investigational medication compared to an already approved medication for treatment of a urinary tract infection.

Description

A Phase III Study in Adolescent and Adult Female Participants Comparing the Efficacy and Safety of a study medication to Nitrofurantoin in the Treatment of Uncomplicated Urinary Tract Infection (Acute Cystitis).

Details
Condition Urinary Tract Infections
Clinical Study IdentifierTX265704
Last Modified on11 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

The participant is ≥12 years of age at the time of signing the informed consent/assent and has a body weight ≥40 kg
The participant has 2 or more of the following clinical signs and symptoms of acute cystitis with onset ≤72 hours prior to study entry: dysuria, frequency, urgency, or lower abdominal pain (see Appendix 5)
The participant has nitrite or pyuria from a pretreatment clean-catch midstream urine sample based on local laboratory procedures
The participant is female. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
The participant is capable of giving signed informed consent/assent

Exclusion Criteria

The participant resides in a nursing home or dependent care type-facility
The participant has a body mass index ≥40.0 kg/m2 or a body mass index
The participant has a history of sensitivity to the study interventions, or components thereof, or a history of a drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates her participation
The participant is immunocompromised or has altered immune defenses that may predispose the participant to a higher risk of treatment failure and/or complications
The participant has any of the following: a.) Medical condition that requires medication that may be impacted by inhibition of acetylcholinesterase, such as: Poorly controlled asthma or chronic obstructive pulmonary disease at Baseline and, in the opinion of the investigator, not stable on current therapy. b.) Acute severe pain, uncontrolled with conventional medical management. c.) Active peptic ulcer disease. d.) Parkinson disease. e.) Myasthenia gravis. f.) A history of seizure disorder requiring medications for control. g.) Any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study intervention
The participant has a known glucose-6-phosphate dehydrogenase deficiency
The participant, in the judgment of the investigator, would not be able or willing to comply with the protocol or complete study follow-up
The participant has a serious underlying disease that could be imminently life threatening, or the participant is unlikely to survive for the duration of the study period
The participant has acute cystitis that is known or suspected to be due to fungal, parasitic, or viral pathogens; or known or suspected to be due to Pseudomonas aeruginosa or Enterobacteriaceae (other than E. coli) as the contributing pathogen
The participant has symptoms known or suspected to be caused by another disease process, such as asymptomatic bacteriuria, overactive bladder, chronic incontinence, or chronic interstitial cystitis, that may interfere with the clinical efficacy assessments
The participant has an anatomical or physiological anomaly that predisposes the participant to UTIs or may be a source of persistent bacterial colonization, including calculi, obstruction or stricture of the urinary tract, primary renal disease (
The participant has an indwelling catheter, nephrostomy, ureter stent, or other foreign material in the urinary tract
The participant who, in the opinion of the investigator, has an otherwise complicated UTI, an active upper UTI, signs and symptom onset ≥96 hours before study entry, or a temperature ≥101°F, flank pain, chills, or any other manifestations suggestive of upper UTI
The participant has known anuria, oliguria, or significant impairment of renal function
The participant presents with vaginal discharge at Baseline
The participant has congenital long QT syndrome or known prolongation of the corrected QT (QTc) interval
The participant has uncompensated heart failure
The participant has severe left ventricular hypertrophy
The participant has a family history of QT prolongation or sudden death
The participant has a recent history of vasovagal syncope or episodes of symptomatic bradycardia or brady arrhythmia within the last 12 months
The participant is taking QT-prolonging drugs or drugs known to increase the risk of torsades de pointes (TdP)
For any participant ≥12 to <18 years of age, the participant has an abnormal ECG reading at Baseline or during the study intervention
The participant has a QTc >450 msec or a QTc >480 msec for participants with bundle-branch block
The participant has a documented or recent history of uncorrected hypokalemia within the past 3 months
The participant has a known alanine aminotransferase (ALT) value >2 × upper limit of normal (ULN)
The participant has a known bilirubin value >1.5 × ULN (isolated bilirubin >1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
The participant has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice
The participant has a previous history of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin
The participant has received treatment with other systemic antimicrobials or systemic antifungals within 1 week before study entry
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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