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Ciprofloxacin BioThrax Co-Administration Study

NCT01753115 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2025-06-15

Study results available
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Summary

The purpose of this clinical trial is to determine whether there is any effect on the antibiotic, ciprofloxacin when taken before and after administration of a 3-dose series of BioThrax® (Anthrax Vaccine Adsorbed or AVA).

This study will be conducted in the United States (US) in 154 healthy male and female volunteer subjects ages 18 to 45.

The duration of study participation for each subject will be approximately 76 days (approximately 2.5 months)

Conditions

  • Anthrax

Interventions

BIOLOGICAL

BioThrax

route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule

DRUG

Ciprofloxacin

500 mg twice a day (Days 1-6, 19-21, 33-35, 40-48).

Sponsors & Collaborators

Principal Investigators

  • Robert Hopkins, MD, MPH, TM · Emergent BioSolutions Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01753115 on ClinicalTrials.gov