Last updated: 02/06/2024 06:11:32
Systemic literature review and meta-analysis for estimating the treatment effect of ceftriaxone in uncomplicated urogenital gonorrhea
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Systematic literature review and meta-analysis to estimate the non-inferiority margin for a phase 3 NI trial in uncomplicated urogenital gonorrhea
Trial description: This observational study is intended to justify a non-inferiority (NI) margin for a phase 3 randomized comparative trial in uncomplicated urogenital gonorrhea. The primary objective of this systematic literature review is to identify historical clinical trials among participants, which have a ceftriaxone and or placebo/proxy for placebo arm, for the treatment of uncomplicated urogenital gonorrhea.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Percentage of participants with microbiological response at the urogenital site only in the micro-intent-to-treat (ITT) study population
Timeframe: Approximately 3 to 7 days post treatment
Secondary outcomes:
Percentage of participants with microbiological response at the urogenital site only in the microbiologically evaluable (ME) study population
Timeframe: Approximately 3 to 7 days post treatment
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2021-11-05
Observational study model:
Other
Time perspective:
Retrospective
Clinical publications:
Fanny S. Mitrani-Gold, Jonathan Fix, Alison Donald. Systematic review and meta-analysis to estimate the treatment effect and inform a non-inferiority margin for a phase 3 non-inferiority trial in uncomplicated urogenital gonorrhoea. Sex Transm Dis. 2022;
DOI: 10.1097/OLQ.0000000000001657
PMID: 35675712
Medical condition
Gonorrhea
Product
gepotidacin
Collaborators
Not applicable
Study date(s)
March 2021 to May 2021
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
- Inclusion criteria:
- Studies of adult and adolescent females and males (more than or equal to [>=]12 years) with uncomplicated urogenital gonorrhea. Studies with participants that have uncomplicated urogenital gonorrhea at other body sites are permitted for inclusion if the efficacy data are reported separately for each body site with the primary efficacy endpoint being microbiological response at the urogenital site only.
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion criteria:
- Studies of adult and adolescent females and males (more than or equal to [>=]12 years) with uncomplicated urogenital gonorrhea. Studies with participants that have uncomplicated urogenital gonorrhea at other body sites are permitted for inclusion if the efficacy data are reported separately for each body site with the primary efficacy endpoint being microbiological response at the urogenital site only.
- Interventions- Ceftriaxone alone or ceftriaxone plus azithromycin.
- Comparator- Placebo or proxy for placebo: a) Microbiological response in those with urogenital isolates with confirmed resistance to the active comparator they were randomized to. b) Spontaneous resolution via molecular microbiological response of urogenital infection from prospective cohort studies of urogenital gonorrhea.
- Outcomes- Bacteriological response or microbiological cure at the test of cure visit assessed from approximately 3 to 7 days post therapy.
- Study design(s)- randomized double-blind clinical trials, randomized clinical trials, open label studies.
- Timeframe/length of follow-up – studies with greater than 3-days of follow-up post therapy will be included on the timing of test of cure (approximately 3-7 days post therapy).
- Report characteristics- English language only publications, peer review publications of clinical trial study results, no limits on years considered, nor location of study. Exclusion Criteria for the first Stage:
- Narrative review.
- Case reports or case series.
- Animal studies.
- Gonorrhea prevention studies.
- Pediatric Clinical trials in children less than (<)12 years where efficacy data are not stratified for those >=12 years of age.
- Prophylaxis studies in uncomplicated urogenital gonorrhea.
- Clinical Trials published in non-English language.
- Observational studies (with the exception of studies that report rates of spontaneous resolution among untreated participants).
- Studies which include participants with concomitant infection requiring systemic antibacterial therapy other than study drugs at the time of randomization.
- Studies with include participants with complicated gonorrhea infection if efficacy data are not stratified.
- Trials focusing on pharmacokinetic or pharmacodynamics of uncomplicated urogenital gonorrhea. Exclusion criteria for the second stage:
- Studies which include participants with complicated and uncomplicated urogenital gonorrhea, whereby the efficacy data are not stratified by indication.
- Clinical studies which provide no efficacy data for objectives listed (bacteriological response).
- Studies which report duplicate data from the same study population and comparators as another primary publication identified.
- Clinical trials which allow for concomitant use of systemic antibiotics for other infections as this could overestimate active comparator treatment effect estimates.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
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
2021-11-05
Actual study completion date
2021-11-05
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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