Surveillance study for investigating gepotidacin against N. gonorrhoeae infections

GSK Gepotidacin GC In vitro Global Surveillance Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2020/03/024190

Enrollment

2000

Registered

2020-03-23

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N998- Other intraoperative and postprocedural complications and disorders of genitourinary system

Interventions

Intervention1: Not Applicable: Not Applicable Control Intervention1: Not Applicable: Not Applicable

Eligibility

Inclusion criteria

Inclusion criteria: 1. Clinically relevant causative isolate â?? The isolate must meet the laboratory criteria of â??significant pathogenâ?? and be considered the â??probable causative agentâ?? of infection. 2. Unique, nonâ??replicate isolates that represent one isolates/body site/patient only. 3. Only include isolates that have been consecutively collected and/or stored on or after January 1, 2018 through December 31, 2020.

Exclusion criteria

Exclusion criteria: 1. Isolates that have been collected and/or stored prior to January 1, 2018 or later than December 31, 2020. 2. Duplicate isolates (same genus and species) obtained from the same or different specimen regardless of whether they were obtained from the same or different body sites. 3. Duplicate isolates (same genus and species) obtained at any subsequent time from the same patient, regardless of susceptibility or phenotypic profile. Environmental samples (nonâ??patient derived) or surveillance cultures taken for infection control purposes. 4. Outside study group â?? any isolate other than those defined by protocol.

Design outcomes

Primary

Measure	Time frame
In this study, global, in vitro surveillance data will be collected over a 3-year period investigating the antimicrobial susceptibility of gepotidacin and comparators against Neisseria gonorrhoeae.Timepoint: End of the study	—

Secondary

Measure	Time frame
This data will support a GlaxoSmithKline LLC (GSK) submission to the FDA and other global regulatory agencies for GSK to obtain regulatory clearance for the treatment of N. gonorrhoeae infections with gepotidacin.Timepoint: End of the study	—

Countries

Australia, Canada, India, South Africa, United States of America

Contacts

Public ContactDr Tarun Mathur

IHMA India LLP

tmathur@ihma.com911244930744

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026