Last updated: 03/05/2025 07:20:10

Meta analysis to estimate the bacteriological treatment effect of nitrofurantoin for determination of the non-inferiority margin in uUTI

GSK study ID
207625
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Meta analysis to estimate the bacteriological treatment effect of nitrofurantoin for determination of the non-inferiority margin in uUTI
Trial description: Uncomplicated UTI (uUTI) affects as many as 50-60 percent of women over the course of their lifetime and is most commonly caused by Escherichia coli (E.coli). It has been identified that there is an urgent need for drugs with potent activity against multi-drug resistant E. coli urinary pathogens. Gepotidacin is one such drug and is being developed for use in subjects with uUTI with limited treatment options due to multi-drug resistance. A clinical trial has been planned to demonstrate efficacy of Gepotidacin against an active control namely Nitrofurantoin. The aim of this meta analysis is to estimate the bacteriological treatment effect of Nitrofurantoin for determination of the non-inferiority margin in uUTI which then will be used in designing the clinical trial. A systematic review will be conducted to identify the published, randomized clinical trials which have a Nitrofurantoin and placebo arm for the treatment of adult subjects with uUTI. It will take place in two phases. In first stage abstracts of all eligible studies will be reviewed and specific studies will be selected. In second stage full text review of the selected studies will be carried out. The finalized studies will then be included in meta-analysis.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Estimation of the placebo bacteriological treatment effect in uUTI using systematic literature review

Timeframe: Up to 17 days

Estimation of the nitrofurantoin bacteriological treatment effect in uUTI using systematic literature review

Timeframe: Up to 15 days

Estimation of the difference in cure rates between active control and placebo in uUTI

Timeframe: Up to 15 days

Determination of the non-inferiority margin for the design of phase 3 registration trial

Timeframe: Up to 15 days

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Nitrofurantoin
  • Drug: Placebo
    • Enrollment:
    0
    Primary completion date:
    2017-10-04
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Mitrani-Gold F, Raychaudhuri A, Rao S. Systematic Review and Meta-analysis to Estimate the Antibacterial Treatment Effect of Nitrofurantoin in Uncomplicated Urinary Tract Infection. J Global Antimicrob Resist. 2020;30030-8 DOI: 10.1016/j.jgar.2020.01.027 PMID: 32084607
    Medical condition
    Infections, Urinary Tract
    Product
    gepotidacin, nitrofurantoin
    Collaborators
    Not applicable
    Study date(s)
    January 2017 to April 2017
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female
    Age
    15+ years
    Accepts healthy volunteers
    none
    • First stage screening: Randomized clinical trials of females with uUTI or acute cystitis where nitrofurantoin one arm of the trial (Nitrofurantoin Search).
    • First stage screening: Randomized clinical trials of females with uUTI or acute cystitis where placebo is one arm of the trial (Placebo Search).
    • First stage screening: Narrative reviews.
    • First stage screening: Case reports or case series.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • First stage screening: Randomized clinical trials of females with uUTI or acute cystitis where nitrofurantoin one arm of the trial (Nitrofurantoin Search).
    • First stage screening: Randomized clinical trials of females with uUTI or acute cystitis where placebo is one arm of the trial (Placebo Search).
    • First stage screening: Open label trials of nitrofurantoin or placebo in symptomatic females with uUTI or acute cystitis.
    Exclusion criteria:
    • First stage screening: Narrative reviews.
    • First stage screening: Case reports or case series.
    • First stage screening: Animal studies.
    • First stage screening: UTI prevention studies.
    • First stage screening: Clinical trial of Asymptomatic bacteriuria (ASB).
    • First stage screening: Clinical trials published in non-English language will be excluded.
    • First stage screening: Observational studies.
    • First stage screening: Studies which include subjects with concomitant infection requiring systemic antibacterial therapy other than study drugs at the time of randomization will be excluded.
    • First stage screening: Studies with include subjects receiving initial Intravenous (IV) antibacterial therapy, or with clinical signs and symptoms of complicated UTI or acute pyelonephritis (fever more than 38 degree within the last 24 hours, flank pain or cost vertebral angle tenderness (CVA), or studies conducted in subject subgroups which are considered complicated UTI (cUTI) based on definitions (that is diabetes, pregnancy, urological procedure or abnormalities, males) will be excluded.
    • First stage screening: Trials focusing on pharmacokinetic or pharmacodynamic variables will be excluded.
    • Second stage screening: Studies which include subjects with cUTI and uUTI, with efficacy data that are not stratified by indication
    • Second stage screening: Studies which provide no data on objectives.
    • Second stage screening: Studies which report duplicate data which is in the same population as another publication.
    • Second stage screening: Clinical trials which allow for concomitant use of antibiotics.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Protocol
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2017-10-04
    Actual study completion date
    2017-10-04

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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