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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: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The competitive index (CI) is defined by the ratio of colony forming units (cfu) of the two strains recovered from urine cultures on the day of treatment (output) compared to the ratio of strains in the inoculum (input): CI = mutant cfu(output)/wild-type cfu(output) ÷ mutant cfu(input)/wild-type cfu(input). The CI is used to assess whether the fitness of a given mutant is different than that of wild-type, and CI as a ratio is compared to 1. If it's not significantly different than 1, then no s
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 |
What the finished NCT03840811 record still lists
NCT03840811 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 5 interventions - of which Ciprofloxacin is the first listed.
NCT03840811 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03840811's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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