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NCT02961751 · ClinicalTrials.gov registry record · NA
Clinical Validation of a Molecular Test for Ciprofloxacin-Susceptibility in Neisseria Gonorrhoeae
A NA study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- NA
- Development phase
- 211
- Enrollment target
NCT02961751: Completed NA study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT02961751 is a NA study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 211 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02961751, a NA study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- NA
- Development phase
- 211 participants
- Enrollment target
Study Summary
This study is a multi-center, single-arm, open-label clinical study to assess the efficacy of one dose of ciprofloxacin given orally in subjects infected with untreated gyrase A (gyrA) serine 91 genotype Neisseria gonorrhoeae (N. gonorrhoeae) as determined by a real-time Polymerase Chain Reaction (PCR) assay. The study will enroll approximately 381 subjects to obtain an eligibility target of 257 subjects, per protocol, age 18 and older regardless of gender identification who are seeking care in Sexually Transmitted Disease (STD) clinics of up to eight of the participating sites in the United States. Subjects who have untreated gyrA serine 91 genotype N. gonorrhoeae of the rectum, or male or female urogenital tract identified by a positive culture or Nucleic Acid Amplification Test (NAAT) conducted at a prior visit will be offered enrollment in the study. They will receive one dose of directly observed ciprofloxacin 500 milligrams. Subjects not consenting to participate in the study will receive treatment per local standard of care. The duration of the study for each subject will be approximately 11 through 14 days. The primary objective of this study is to determine the efficacy of ciprofloxacin for treatment of uncomplicated N. gonorrhoeae infections with gyrA serine 91 genotype.
Primary Outcome
Subjects infected with gyrase A (gyrA) serine 91 genotype of Neisseria gonorrhoeae (N. gonorrhoeae) were evaluated for microbiological cure at 5-10 days after treatment. Cure was defined as N. gonorrhoeae not detectable by culture from all anatomical sites that had detectable N. gonorrhoeae at baseline.
Interventions
- DRUG Ciprofloxacin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 211 participants |
| Start Date | 2016-10-19 |
| Est. Completion | 2019-01-04 |
| Phase | NA |
What the finished NCT02961751 record still lists
NCT02961751 is an interventional study that assigns participants to a tested intervention. The registered 211 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which Ciprofloxacin is the first listed.
NCT02961751 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02961751 about?
NCT02961751 is a clinical study titled "Clinical Validation of a Molecular Test for Ciprofloxacin-Susceptibility in Neisseria Gonorrhoeae". This study is a multi-center, single-arm, open-label clinical study to assess the efficacy of one dose of ciprofloxacin given orally in subjects infected with untreated gyrase A (gyrA) serine 91 genotype Neisseria gonorrhoeae (N. gonorrhoeae) as determined by a real-time Polymerase Chain Reaction (P...
What is the current status of trial NCT02961751?
This trial is currently completed. It is a NA study. The enrollment target is 211 participants. The study started on 2016-10-19. Estimated completion is 2019-01-04.
What interventions are being tested in trial NCT02961751?
The interventions under investigation include: Ciprofloxacin (DRUG).
Who is sponsoring clinical trial NCT02961751?
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 NCT02961751's enrollment target sits among peer trials
211 490th of 2000 higher than 1,511 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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