Status:
COMPLETED
Experimental Human Infection With Neisseria Gonorrhoeae (LptA Trial)
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Gonococcal Infection
Eligibility:
MALE
18-35 years
Phase:
PHASE1
Brief 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 t...
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- Healthy man between the ages of 18 and 35 years.
- Able and willing to be located easily by providing street address and telephone number (land line and/or cell phone number).
- Willingness to provide written informed consent.
- Able and willing to attend all study visits including 6-day stay in the Clinical and Translational Research Center (CTRC) during the trial (with ability to leave the unit during the day) and follow-up visit during the week after treatment.
- Able and willing to abstain from masturbation during the 6-day stay in the CTRC.
- Able and willing to abstain from all sexual activity during the course of the study.
- Acceptable medical history by screening evaluation.
- Standard physical exam within normal limits (WNL).
- Serum creatinine WNL.
- Serum alanine transaminase (ALT) WNL.
- White blood cell (WBC), polymorphonuclear cell (PMN) and hemoglobin values WNL.
- Normal urinalysis.
- Total Complement (CH50) WNL.
- Urine negative for chlamydia, gonorrhea, trichomonas and mycoplasma.
- Negative HIV, syphilis, and Hepatitis C (HCV) test results.
- Negative Hepatitis B (HBV) core and surface antibodies or results consistent with immunization (negative HBV core antibody/positive HBV surface antibody).
- Denies history of STIs including syphilis and hepatitis B \& C.
- Denies history of bleeding diathesis.
- Denies history of seizures (due to reports of seizures with ciprofloxacin).
- Denies history of cancer, except basal cell carcinoma of the skin more than 5 years ago.
- Denies history of drug abuse.
- Denies history of psychiatric disorders, except depression controlled by medication.
- Denies history of genitourinary surgery.
Exclusion
- Student or employee under the direct supervision of any of the study investigators.
- Any known immunodeficiencies including complement deficiency, antibody deficiency, chronic granulomatous disease or HIV infection.
- Psychiatric disorders that would interfere with the integrity of the data or volunteer safety.
- Unstable depression (defined as receiving either \< 3 months of the same medication (and dose) or a decompensating event during the previous 3 months) or depression that, in the opinion of the investigator, will compromise the subject's ability to comply with protocol requirements.
- Heart murmur or heart disease.
- Anatomic abnormality of the urinary tract.
- Any antibiotic treatment in the past 30 days, or azithromycin in the past 60 days.
- Chemotherapy within the past year.
- Current steroid use, except for topical application.
- Allergy to penicillin, ceftriaxone or ciprofloxacin or to lidocaine.
- Treatment with medications that are contraindicated with ciprofloxacin or ceftriaxone and that cannot be withheld for the single doses given in this study.
Key Trial Info
Start Date :
March 10 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2015
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04870138
Start Date
March 10 2013
End Date
April 28 2015
Last Update
December 2 2021
Active Locations (1)
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1
University of North Carolina Health Care - Infectious Diseases
Chapel Hill, North Carolina, United States, 27514-4220