Status:
COMPLETED
Experimental Human Infection With Neisseria Gonorrhoeae
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Gonococcal Infection
Eligibility:
MALE
18-36 years
Phase:
PHASE1
Brief 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 tes...
Detailed Description
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 tes...
Eligibility Criteria
Inclusion
- Healthy man \> / = 18 and \< 36 years old
- 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 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 all sexual activity until completion of the study and the follow-up test for gonorrhea is negative
- Acceptable medical history by screening evaluation
- No clinically significant abnormalities on physical exam
- Urinalysis: leukocyte esterase, and White Blood Cell (WBC) values within normal limits (WNL)
- CH50 WNL
- Urine negative for chlamydia, gonorrhea, and trichomonas
- Negative Human Immunodeficiency Virus (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 Sexually Transmitted Infections (STIs) including gonorrhea, chlamydia, syphilis, HIV, HBV, and HCV
- 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 \> 5 years ago
- Denies history of drug abuse
- 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 Human Immunodeficiency Virus (HIV) infection
- Psychiatric disorders that, in the opinion of the physician, 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
- Self-reported chemotherapy within the past year
- Current steroid use, except for topical application
- Allergy to penicillin, cephalosporins or ciprofloxacin or to lidocaine
- Treatment with medications in the previous month that are contraindicated with cefixime, ceftriaxone or ciprofloxacin and that cannot be withheld for the single doses given in this study
- Serum creatinine level \< 0.7 or \> 1.75 mg/dL and deemed clinically significant by the study physician
- Serum ALT level \< LLN or \> 105 U/L and deemed clinically significant by the study physician
- WBC count \< 2.5 or \> 15.0 x 10\^9/L and deemed clinically significant by the study physician
- Absolute neutrophil count (ANC) \< 1.5 or \> 7.5 x 10\^9/L and deemed clinically significant by the study physician Exception: For African Americans, ANC values as low as 1.3 x 10\^9/L will be allowed (25)
- Hemoglobin level \< 12.0 g/dL or above ULN and deemed clinically significant by the study physician
- Urinalysis: Qualitative protein level \> 1+ or RBC count \> 10/hpf
- Medications not permitted with cefixime or ceftriaxone:
- Warfarin
- Probenecid
- Aspirin
- Diuretics such as furosemide
- Aminoglycoside antibiotics
- Chloramphenicol
- Medications not permitted with ciprofloxacin:
- Tizanidine
- Theophylline
- Warfarin
- Glyburide
- Cyclosporine
- Probenecid
- Phenytoin
- Methotrexate
- Antacids, multivitamins, and other dietary supplements containing magnesium, calcium, aluminum, iron or zinc
- Caffeine-containing medications
- Sucralfate or didanosine chewable or buffered tablets
Key Trial Info
Start Date :
April 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 25 2019
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03840811
Start Date
April 23 2017
End Date
November 25 2019
Last Update
March 23 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