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Trial · NCT05254808

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryTime to recovery28 days
Duration of absence of cystitis symptoms is defined as 'the number of days with full resolution of relevant cystitis symptoms, in the absence of aggravation to pyelonephritis or urosepsis within the period of 28 days after randomisation'
SecondaryClinical failure28 daysRate of clinical failure, defined as new or persisting cystitis symptoms or aggravation to pyelonephritis or urosepsis for which a new antibiotic treatment was prescribed within 28 days
SecondaryMicrobiological failure28 daysRate of microbiological failure at day 28 (26 to 31) defined as persistence of the initial infecting organism (≥ 103 colony forming units (cfu) /ml)
SecondaryDevelopment of pyelonephritis or urosepsis28 days
Rate of pyelonephritis or urosepsis, defined as the occurrence of signs or symptoms of pyelonephritis or urosepsis (fever, flank pain, or other matching symptoms) for which antibiotic treatment was prescribed\*
SecondaryRelapse28 daysRate of relapses at day 28, defined as clinical failure caused by the initial infecting organism (\> 103 cfu /ml)
SecondaryReinfection28 daysRate of reinfections at day 28, defined as clinical failure caused by another organism than the initial infecting organism
SecondaryAll-cause mortality28 daysRate of mortality (all-cause)
SecondaryAll-cause hospital admission28 daysRate of hospital admission (all-cause)
SecondaryAdverse events symptoms28 daysDuration of adverse events symptoms (including diarrhea, nausea, abdominal cramps, increased vaginal discharge or other).
SecondaryIncidence and nature of severe adverse events28 days
SecondaryTherapy adherence7 daysRate of complete self-reported therapy adherence
SecondarySatisfaction with treatment28 daysSatisfaction with the treatment received on a scale of 5. A scale from 1 to 5 will be calculated for each comparison and will be reported with corresponding 98.3% confidence intervals.
SecondaryAbsenteeism education or work28 daysNumber of days of absenteeism: * education * (voluntary) work

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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