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NCT03840811 · ClinicalTrials.gov registry record · Phase 1
Experimental Human Infection With Neisseria Gonorrhoeae
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT03840811 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 27 participants.
The verdict
NCT03840811, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
This is a Phase 1, interventional, non-randomized, experimental infection model study with healthy adult males adults (N=32) between the ages of 18-36 at study enrollment. The study is designed to test the requirements of predicted N. gonorrhoeae virulence determinants for gonococcal infection in the male urethra. The duration for all participants will be about 3 weeks. Study duration will be approximately about 18 months for implementation and enrollment. The primary objectives of the present study are to: (1) compare infectivity of different isogenic mutants with wild-type (WT) N. gonorrhoeae in noncompetitive infections and to (2) assess relative fitness of the mutant in competitive infections initiated by inocula containing equivalent numbers of both WT and mutant strains for mutants with WT infectivity.
Interventions
- DRUG Ciprofloxacin
- DRUG Ceftriaxone
- DRUG Cefixime
- BIOLOGICAL Neisseria gonorrhoeae strain FA1090 A26
- BIOLOGICAL Neisseria gonorrhoeae strain FA7537
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2017-04-23 |
| Est. Completion | 2019-11-25 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03840811
The ClinicalTrials.gov registry entry for NCT03840811 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 27 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 Ciprofloxacin is the first listed.
NCT03840811 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03840811 about?
NCT03840811 is a clinical study titled "Experimental Human Infection With Neisseria Gonorrhoeae". This is a Phase 1, interventional, non-randomized, experimental infection model study with healthy adult males adults (N=32) between the ages of 18-36 at study enrollment. The study is designed to test the requirements of predicted N. gonorrhoeae virulence determinants for gonococcal infection in th...
What is the current status of trial NCT03840811?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2017-04-23. Estimated completion is 2019-11-25.
What interventions are being tested in trial NCT03840811?
The interventions under investigation include: Ciprofloxacin (DRUG), Ceftriaxone (DRUG), Cefixime (DRUG), Neisseria gonorrhoeae strain FA1090 A26 (BIOLOGICAL), Neisseria gonorrhoeae strain FA7537 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03840811?
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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