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NCT04870138 · ClinicalTrials.gov registry record · Phase 1
Experimental Human Infection With Neisseria Gonorrhoeae (LptA Trial)
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT04870138 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 16 participants.
The verdict
NCT04870138, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
This is a Phase 1, interventional, non-randomized, experimental infection model study in healthy adult males (N=up to 25) between the ages of 18-35 at study enrollment. The study is designed to test the requirements of predicted N. gonorrhoeae virulence determinants for gonococcal infection in the male urethra through infection with engineered mutants of N. gonorrhoeae. We predict that mutations abolishing expression of N. gonorrhoeae virulence determinants will eliminate or significantly reduce gonococcal infectivity or the ability to induce inflammation in an infected individual, thus identifying potential vaccine candidates. Study duration will be 1 year, and the duration for all participants will be about 3 weeks. The primary objective of the study is to compare the ability of different engineered mutants of Neisseria gonorrhoeae to cause a clinical infection (signs or symptoms of urethritis such as discomfort during urination, urethral discharge, etc.) in the male urethra.
Interventions
- DRUG Azithromycin
- DRUG Ciprofloxacin
- DRUG Ceftriaxone
- BIOLOGICAL Neisseria gonorrhoeae strain FA1090 A26
- BIOLOGICAL Neisseria gonorrhoeae strain FA7527
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2013-03-10 |
| Est. Completion | 2015-04-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04870138
The ClinicalTrials.gov registry entry for NCT04870138 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Azithromycin is the first listed.
NCT04870138 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04870138 about?
NCT04870138 is a clinical study titled "Experimental Human Infection With Neisseria Gonorrhoeae (LptA Trial)". This is a Phase 1, interventional, non-randomized, experimental infection model study in healthy adult males (N=up to 25) between the ages of 18-35 at study enrollment. The study is designed to test the requirements of predicted N. gonorrhoeae virulence determinants for gonococcal infection in the m...
What is the current status of trial NCT04870138?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2013-03-10. Estimated completion is 2015-04-28.
What interventions are being tested in trial NCT04870138?
The interventions under investigation include: Azithromycin (DRUG), Ciprofloxacin (DRUG), Ceftriaxone (DRUG), Neisseria gonorrhoeae strain FA1090 A26 (BIOLOGICAL), Neisseria gonorrhoeae strain FA7527 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04870138?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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