NCT01949363View on ClinicalTrials.gov

The Pharmacokinetics of Extended Duration High-dose Cefixime for the Decreased Susceptibility of Neisseria Gonorrhoeae: A Phase I Pilot Study

PHASE1CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

December 31, 2013

Primary Completion Date

February 28, 2015

Study Completion Date

December 31, 2015

Conditions
Gonorrhoea
Interventions
DRUG

Cefixime

Cefixime is an FDA approved oral semi-synthetic cephalosporin antibiotic. The standard dose (400mg), high dose (800mg and 1200mg), and multiple 800mg and 1200mg doses given over a 24-hour period using a dose-frequency escalation method. Cohort A receives 400 mg orally once, Cohort B receives 800 mg orally once; Cohort C receives 1200 mg orally once; Cohort D receives 800 mg orally 3 times (every 8 hrs)

Trial Locations (1)

21224-2735

Johns Hopkins Bayview Medical Center - Infectious Diseases, Baltimore

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT01949363 - The Pharmacokinetics of Extended Duration High-dose Cefixime for the Decreased Susceptibility of Neisseria Gonorrhoeae: A Phase I Pilot Study | Biotech Hunter | Biotech Hunter